A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04546009
• Collaborator: (none)
• Enrollment: 978
• Locations: 365
• Arms: 2
• Anticipated Duration (Months): 77.2
• Patients Per Site: 2.7
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.

Condition or Disease	Intervention/Treatment	Phase
Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer	Drug: Giredestrant; Drug: Giredestrant-matched Placebo; Drug: Letrozole; Drug: Letrozole-matched Placebo; Drug: Palbociclib; Drug: LHRH Agonist	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 978 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
• Actual Study Start Date: Oct 9, 2020
• Anticipated Primary Completion Date: Apr 26, 2024
• Anticipated Study Completion Date: Mar 18, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Giredestrant + Letrozole-matched Placebo + Palbociclib	Drug: Giredestrant; Giredestrant is taken orally once per day on Days 1-28 of each 28-day treatment cycle.; Other Names: GDC-9545 RO7197597 RG6171 ; Drug: Letrozole-matched Placebo; Letrozole-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.; Drug: Palbociclib; Palbociclib 125 mg is taken orally once per day on Days 1-21 of each 28-day treatment cycle.; Drug: LHRH Agonist; Only premenopausal/perimenopausal and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.
Active Comparator: Letrozole + Giredestrant-matched Placebo + Palbociclib	Drug: Giredestrant-matched Placebo; Giredestrant-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.; Drug: Letrozole; Letrozole 2.5 milligrams (mg) is taken orally once per day on Days 1-28 of each 28-day treatment cycle.; Drug: Palbociclib; Palbociclib 125 mg is taken orally once per day on Days 1-21 of each 28-day treatment cycle.; Drug: LHRH Agonist; Only premenopausal/perimenopausal and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.

Outcome Measures

Primary Outcome Measures

1. Progression-Free Survival (PFS), as Determined by the Investigator According to RECIST v1.1 [From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 78 months)]

Secondary Outcome Measures

1. Overall Survival [From randomization to death from any cause (up to 78 months)]

2. Objective Response Rate, as Determined by the Investigator According to RECIST v1.1 [From randomization until disease progression or death (up to 78 months)]

   The objective response rate is defined as the percentage of participants with a complete response or partial response on two consecutive occasions at least (≥)4 weeks apart.

3. Duration of Response, as Determined by the Investigator According to RECIST v1.1 [From first occurrence of documented objective response to disease progression or death from any cause, whichever occurs first (up to 78 months)]

4. Clinical Benefit Rate, as Determined by the Investigator According to RECIST v1.1 [From randomization until disease progression or death (up to 78 months)]

   The clinical benefit rate is defined as the percentage of participants with stable disease for ≥24 weeks or a complete response or partial response.

5. Time to Deterioration in Pain Level, Defined as the Time to First Documented ≥2-Point Increase from Baseline in the 'Worst Pain' Item from the Brief Pain Inventory-Short Form (BPI-SF) Questionnaire [From Baseline until treatment discontinuation (up to 78 months)]

6. Time to Deterioration in Pain Presence and Interference, Defined as the Time to First Documented ≥10-Point Increase from Baseline in the EORTC QLQ-C30 Linearly Transformed Pain Scale Score [From Baseline until treatment discontinuation (up to 78 months)]

   EORTC QLQ-C30 = European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire

7. Time to Deterioration in Physical Functioning, Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed Physical Functioning Scale Score [From Baseline until treatment discontinuation (up to 78 months)]

8. Time to Deterioration in Role Functioning, Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed Role Functioning Scale Score [From Baseline until treatment discontinuation (up to 78 months)]

9. Time to Deterioration in Global Health Status and Quality of Life (GHS/QoL), Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed GHS/QoL Scale Score [From Baseline until treatment discontinuation (up to 78 months)]

10. Number of Participants with Adverse Events, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) [From treatment initiation until 30 days after the final dose of study treatment (up to 78 months)]

11. Number of Participants with Vital Sign Abnormalities Over the Course of the Study [Baseline, Days 1 and 15 of Cycles 1 and 2, and Day 1 of each cycle thereafter until treatment discontinuation (1 cycle is 28 days)]

    Vital signs include respiratory rate, pulse rate, and systolic and diastolic blood pressure while the participant is in a seated position, and temperature.

12. Plasma Concentration of Giredestrant at Specified Timepoints [Days 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 8, and 16 (1 cycle is 28 days)]

13. Plasma Concentration of Palbociclib at Specified Timepoints [Days 1 and 15 of Cycle 1 (1 cycle is 28 days)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• For women who are premenopausal or perimenopausal and for men: treatment with approved LHRH agonist therapy for the duration of study treatment

• Locally advanced (recurrent or progressed) or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent

• Documented ER-positive tumor and HER2-negative tumor, assessed locally

• Patients who have bilateral breast cancers which are both ER-positive and HER2-negative can be included in the study because the metastases are suitably targeted by the study treatments. If patients have bilateral tumors which are of different biomarker status, then proof of the ER and HER2 status of the metastases is required for study entry

• No history of systemic anti-cancer therapy for locally advanced (recurrent or progressed) or metastatic disease

• Disease recurrence from early-stage breast cancer after standard adjuvant endocrine therapy meeting the protocol-defined criteria of having received at least 24 months of treatment without disease progression during treatment and a disease-free interval since the completion of treatment that was greater than 12 months

• Measurable disease as defined per RECIST v.1.1 or bone only disease which must have at least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed

• Eastern Cooperative Oncology Group Performance Status 0-1

• Adequate organ function

Exclusion Criteria:

• Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with an aromatase inhibitor (AI)

• Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with any CDK4/6 inhibitor

• Prior treatment with a selective estrogen receptor degrader (SERD)

• Prior treatment with tamoxifen is permitted, provided the patient did not experience disease recurrence within the first 24 months of treatment with tamoxifen

• Treatment with any investigational therapy within 28 days prior to study treatment

• Advanced, symptomatic, visceral spread that is at risk of life-threatening complications

• Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease

• Active cardiac disease or history of cardiac dysfunction

• Pregnant or breastfeeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alaska Oncology and Hematology	Anchorage	Alaska	United States	99508
2	Long Beach Memorial Medical Center	Fountain Valley	California	United States	92708
3	Orange Coast Memorial Medical Center	Fountain Valley	California	United States	92708
4	Los Angeles Hematology Oncology Medical Group	Los Angeles	California	United States	90017
5	Kaiser Permanente - Oakland	Oakland	California	United States	94611
6	California Cancer Associates for Research & Excellence, Inc.	Poway	California	United States	92069
7	Kaiser Permanente - Roseville	Roseville	California	United States	95661
8	Kaiser Permanente - San Francisco Medical Center	San Francisco	California	United States	94118
9	Kaiser Permanente - San Leandro Medical Center	San Leandro	California	United States	94577
10	Kaiser Permanente - South San Francisco	South San Francisco	California	United States	94080
11	Stanford Univ Medical Center	Stanford	California	United States	94305
12	Kaiser Permanente - Vallejo	Vallejo	California	United States	94589
13	Kaiser Permanente - Walnut Creek	Walnut Creek	California	United States	94596
14	University of Colorado	Aurora	Colorado	United States	80045-2517
15	Rocky Mountain Cancer Center	Denver	Colorado	United States	80218
16	St Mary's Hospital and Medical Center	Grand Junction	Colorado	United States	81502-1628
17	Norwalk Hospital	Norwalk	Connecticut	United States	06856
18	University of Miami; Dept Sylvester Cancer Center	Deerfield Beach	Florida	United States	33442
19	Florida Cancer Specialists - Fort Myers (Broadway)	Fort Myers	Florida	United States	33901
20	Memorial Regional Cancer Ctr	Hollywood	Florida	United States	33021
21	Miami Cancer Institute of Baptist Health, Inc.	Miami	Florida	United States	33176
22	Miami Cancer Institute-Plantation	Plantation	Florida	United States	33324
23	SCRI Florida Cancer Specialists North; Research Office North Region.	Saint Petersburg	Florida	United States	33705
24	SCRI Florida Cancer Specialists PAN	Tallahassee	Florida	United States	32308
25	Northwest Georgia Oncology Centers PC - Marietta	Marietta	Georgia	United States	30060
26	Kaiser Permanente - Moanalua Medical Center	Honolulu	Hawaii	United States	96819-1469
27	Norton Cancer Institute - St. Matthews	Louisville	Kentucky	United States	40207
28	Mercy Medical Center	Baltimore	Maryland	United States	21202
29	Maryland Oncology Hematology; Maryland Oncology Hematology, PA	Silver Spring	Maryland	United States	20902
30	Massachusetts General Hospital	Boston	Massachusetts	United States	02114-2621
31	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
32	US oncology research at Minnesota Oncology	Saint Paul	Minnesota	United States	55102
33	HCA Midwest Division	Kansas City	Missouri	United States	64132
34	St. Vincent Frontier Cancer Center	Billings	Montana	United States	59101
35	Memorial Sloan Kettering Cancer Center Basking Ridge	Basking Ridge	New Jersey	United States	07920
36	Cooper Cancer Institute	Camden	New Jersey	United States	08103
37	Astera Cancer Care East Brunswick	East Brunswick	New Jersey	United States	08816
38	Memorial Sloan Kettering - Monmouth	Middletown	New Jersey	United States	07748
39	Memorial Sloan Kettering Cancer Center at Bergen	Montvale	New Jersey	United States	07645
40	Jefferson Health New Jersey	Sewell	New Jersey	United States	08080
41	UNM Lovelace	Albuquerque	New Mexico	United States	87102
42	New Mexico Oncology Hematology Consultants	Albuquerque	New Mexico	United States	87109
43	Presbyterian Kaseman Hospital	Albuquerque	New Mexico	United States	87110
44	University of New Mexico Cancer Center	Albuquerque	New Mexico	United States	87131
45	San Juan Oncology Associates	Farmington	New Mexico	United States	87401
46	Memorial Medical Center	Las Cruces	New Mexico	United States	88011
47	Presbyterian Rust Medical Center/Jorgensen Cancer Center	Rio Rancho	New Mexico	United States	87124
48	New York Cancer and Blood Specialists-Eastchester Cancer Center	Bronx	New York	United States	10469
49	MSKCC @ Commack	Commack	New York	United States	11725
50	Memorial Sloan Kettering Cancer Center at Westchester	Harrison	New York	United States	10604
51	New York Cancer and Blood Specialists - New Hyde Park	New Hyde Park	New York	United States	11042
52	New York Cancer and Blood Specialists-Central Park Hematology & Oncology	New York	New York	United States	10028
53	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
54	North Shore Hematology Oncology Associates, d.b.a. New York Cancer and Blood Specialists	Port Jefferson Station	New York	United States	11776
55	Memorial Sloan Kettering Cancer Center at Nassau	Uniondale	New York	United States	11553
56	Waverly Hematology Oncology	Cary	North Carolina	United States	27518
57	Fairview Hospital; Cleveland Clinic Cancer Center	Cleveland	Ohio	United States	44111
58	The Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
59	Hillcrest Hospital; Hirsch Cancer Center	Mayfield Heights	Ohio	United States	44124
60	Strongsville Hospital; Cleveland Clinic Cancer Center	Strongsville	Ohio	United States	44136
61	Hightower Clinical	Oklahoma City	Oklahoma	United States	73102-1077
62	Providence Portland Medical Ctr	Portland	Oregon	United States	97225
63	Ann B. Barshinger Cancer Institute	Lancaster	Pennsylvania	United States	17604
64	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States	19107
65	Asplundh Cancer Pavilion	Willow Grove	Pennsylvania	United States	19090
66	Charleston Oncology, P .A	Charleston	South Carolina	United States	29414
67	West Cancer Center	Germantown	Tennessee	United States	38138
68	Sarah Cannon Research Inst.	Nashville	Tennessee	United States	37203
69	Harrington Cancer Center	Amarillo	Texas	United States	79106
70	Texas Oncology - Austin	Austin	Texas	United States	78745
71	Texas Oncology-Baylor Sammons Cancer Center	Dallas	Texas	United States	75246
72	Texas Oncology (Flower Mound) - USOR	Flower Mound	Texas	United States	75028
73	Texas Oncology, P.A. - Fort Worth	Fort Worth	Texas	United States	76104
74	The Center for Cancer and Blood Disorders - Fort Worth	Fort Worth	Texas	United States	76104
75	Baylor St. Luke's Medical Center	Houston	Texas	United States	77030
76	Houston Methodist Hospital	Houston	Texas	United States	77030
77	Texas Oncology McKinney	McKinney	Texas	United States	75071
78	Texas Oncology Cancer Center - Sugarland	Sugar Land	Texas	United States	77479
79	Renovatio Clinical	The Woodlands	Texas	United States	77380
80	Texas Oncology, P.A. - Tyler; Tyler Cancer Center	Tyler	Texas	United States	75702
81	Texas Oncology, P.A.; Duke Slayton Cancer Center	Webster	Texas	United States	77598-4420
82	Virginia Cancer Specialists, PC	Fairfax	Virginia	United States	22031
83	Inova Fairfax Hospital	Falls Church	Virginia	United States	22031
84	Bon Secours St. Francis Medical Center Oncology Research	Midlothian	Virginia	United States	23114
85	Virginia Oncology Associates	Norfolk	Virginia	United States	23502
86	Providence Regional Cancer Partnership	Everett	Washington	United States	98201
87	Northwest Medical Specialties	Tacoma	Washington	United States	98405
88	University of Wisconsin	Madison	Wisconsin	United States	53792
89	Fundación CENIT para la Investigación en Neurociencias	Buenos Aires		Argentina	C1125ABD
90	Hospital Britanico	Ciudad Autonoma Bs As		Argentina	C1280AEB
91	Hospital de Onc Angel Roffo	Ciudad Autonoma Buenos Aires		Argentina	C1417DTB
92	Instituto de Investigaciones Metabolicas (Idim)	Ciudad Autonoma de Buenos Aires		Argentina	C1012AAR
93	Instituto de Oncología de Rosario	Rosario		Argentina	S2000KZE
94	Hospital Provincial del Centenario	Rosario		Argentina	S2002KDS
95	CEMER Centro Medico de Enfermedades Respiratorias	Vicente López		Argentina	B1602DQD
96	Chris O'Brien Lifehouse	Camperdown	New South Wales	Australia	2050
97	Kinghorn Cancer Centre; St Vincents Hospital	Darlinghurst	New South Wales	Australia	2010
98	Calvary Mater Newcastle; Medical Oncology	Waratah	New South Wales	Australia	2298
99	Mater Hospital Brisbane	South Brisbane	Queensland	Australia	4101
100	Princess Alexandra Hospital; Division of Cancer Services	Woolloongabba	Queensland	Australia	4102
101	Flinders Medical Centre; Medical Oncology	Bedford Park	South Australia	Australia	5042
102	Frankston Hospital	Frankston	Victoria	Australia	3199
103	Austin Health; Cancer Clinical Trial Centre	Heidelberg	Victoria	Australia	3084
104	Peter MacCallum Cancer Centre-East Melbourne	Melbourne	Victoria	Australia	3000
105	Sunshine Hospital	St Albans	Victoria	Australia	3021
106	Fiona Stanley Hospital - Medical Oncology	Murdoch	Western Australia	Australia	6150
107	Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie	Innsbruck		Austria	6020
108	Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU	Salzburg		Austria	5020
109	A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie	Steyr		Austria	4400
110	Landesklinikum Wiener Neustadt; Innere Medizin, Hämatologie u. internistische Onkologie	Wiener Neustadt		Austria	2700
111	Medizinische Universität Wien; Univ.Klinik für Innere Medizin I	Wien		Austria	1090
112	CHIREC	Auderghem		Belgium	1160
113	Cliniques Universitaires St-Luc	Bruxelles		Belgium	1200
114	Jessa Zkh (Campus Virga Jesse)	Hasselt		Belgium	3500
115	Hospital Sao Rafael - HSR	Salvador	BA	Brazil	41253-190
116	Hospital Araujo Jorge; Departamento de Ginecologia E Mama	Goiania	GO	Brazil	74605-070
117	Hospital do Cancer de Pernambuco - HCP	Recife	PE	Brazil	50040-000
118	Santa Casa de Misericordia de Porto Alegre	Porto Alegre	RS	Brazil	90050-170
119	Hospital Sao Lucas - PUCRS	Porto Alegre	RS	Brazil	90610-000
120	Hospital de Base de Sao Jose do Rio Preto	Sao Jose do Rio Preto	SP	Brazil	15090-000
121	Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda	Sao Paulo	SP	Brazil	01317-001
122	Beneficencia Portuguesa de Sao Paulo	São Paulo	SP	Brazil	01321-00
123	Tom Baker Cancer Centre-Calgary	Calgary	Alberta	Canada	T2N 4N2
124	BC Cancer - Surrey	Surrey	British Columbia	Canada	V3V 1Z2
125	BC Cancer - Victoria	Victoria	British Columbia	Canada	V8R 6V5
126	Royal Victoria Regional Health Centre	Barrie	Ontario	Canada	L4M 6M2
127	William Osler Health System Brampton Civic Hospital	Brampton	Ontario	Canada	L6R 3J7
128	Ottawa Hospital Research Institute	Ottawa	Ontario	Canada	K1Y 4E9
129	Princess Margaret Cancer Center	Toronto	Ontario	Canada	M5G 1Z5
130	Universite de Montreal - Hopital Maisonneuve-Rosemont	Montreal	Quebec	Canada	H1T 2M4
131	Centre Hospitalier de l'Université de Montréal (CHUM)	Montreal	Quebec	Canada	H2X 0C2
132	Jewish General Hospital	Montreal	Quebec	Canada	H3T 1E2
133	McGill University Health Center	Montreal	Quebec	Canada	H4A 3J1
134	Hopital du Saint Sacrement	Quebec City	Quebec	Canada	G1S 4L8
135	Centre Hospitalier Regional De Rimouski	Rimouski	Quebec	Canada	G5L 5T1
136	Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont	Sherbrooke	Quebec	Canada	J1H 5N4
137	Anyang Tumor Hosptial	Anyang City		China	455000
138	Affiliated Hospital of Hebei University; Department of medical oncology	Baoding		China	071000
139	Peking University People's Hospital	Beijing		China	100044
140	Beijing Cancer Hospital	Beijing		China	100142
141	the First Affiliated Hospital of Bengbu Medical College	Bengbu City		China	233000
142	The First Hospital of Jilin University	Changchun City		China	130021
143	Hunan Cancer Hospital	Changsha City		China	410013
144	Sichuan Cancer Hospital	Chengdu City		China	610041
145	West China Hospital, Sichuan University; Department of Breast	Chengdu		China	610041
146	Fujian Medical University Union Hospital	Fuzhou City		China	350001
147	The First Affiliated Hospital, Sun Yat-sen University; Thyroid and Breast Surgery	Guangzhou City		China	510080
148	Sun Yat-sen Memorial Hospital	Guangzhou		China	510000
149	Sun Yet-sen University Cancer Center	Guangzhou		China	510060
150	Sir Run Run Shaw Hospital Zhejiang University	Hangzhou City		China	310016
151	Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department	Hangzhou City		China	310022
152	Zhejiang Provincial People's Hospital	Hangzhou		China	310014
153	Harbin Medical University Cancer Hospital	Harbin		China	150081
154	Shandong Cancer Hospital	Jinan		China	250117
155	The First Affiliated Hospital to Henan University of Science and Technology	Luoyang		China	471003
156	The Third Hospital of Nanchang	Nanchang City		China	330009
157	Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)	Nanjing City		China	210029
158	Guangxi Cancer Hospital of Guangxi Medical University	Nanning		China	530021
159	Zhongshan Hospital Fudan University	Shanghai		China	200032
160	Cancer Hospital of Shantou University Medical College	Shantou		China	515041
161	Shengjing Hospital of China Medical University	ShenYang		China	110004
162	Liaoning cancer Hospital & Institute	Shenyang		China	110042
163	Tianjin Cancer Hospital	Tianjin		China	300060
164	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan City		China	430023
165	Hubei Cancer Hospital	Wuhan		China	430079
166	The First Affiliated Hospital of Xian Jiao Tong University	Xi'an City		China	710061
167	Herlev Hospital; Afdeling for Kræftbehandling	Herlev		Denmark	2730
168	Sjællands Universitetshospital, Næstved; Onkologisk Afdeling	Naestved		Denmark	4700
169	Odense Universitetshospital, Onkologisk Afdeling R	Odense C		Denmark	5000
170	Vejle Sygehus; Onkologisk Afdeling	Vejle		Denmark	7100
171	ICO Paul Papin; Oncologie Medicale.	Angers		France	49055
172	Centre Hospitalier de La Cote Basque; Oncologie	Bayonne		France	64109
173	CHD DE VENDEE; Unité de Recherche Clinique Onco-Hematologie	La Roche Sur Yon		France	85925
174	Institut régional du Cancer Montpellier	Montpellier		France	34298
175	Institut Curie; Oncologie Medicale	Paris		France	75231
176	Chu La Miletrie; Oncologie Medicale	Poitiers		France	86021
177	Institut Jean Godinot; Oncologie Medicale	Reims CEDEX		France	51056
178	Centre Eugene Marquis; Service d'oncologie	Rennes		France	35042
179	Centre Alexis Vautrin; Oncologie Medicale	Vandoeuvre-les-nancy		France	54519
180	Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters	Berlin		Germany	13581
181	Städtisches Klinikum Brandenburg GmbH; Klinik für Gynäkologie und Geburtshilfe	Brandenburg an der Havel		Germany	14770
182	Klinikum Chemnitz gGmbH; Frauen- und Kinderklinik	Chemnitz		Germany	09116
183	Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden	Dresden		Germany	01307
184	Universitätsklinikum Essen; Zentrum Für Frauenheilkunde	Essen		Germany	45122
185	Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe	Esslingen		Germany	73730
186	Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH	Georgsmarienhütte		Germany	49124
187	Dres.Andreas Ammon und Dirk Meyer	Göttingen		Germany	37073
188	Universitätsklinikum Hamburg-Eppendorf; Frauenklinik	Hamburg		Germany	20246
189	Facharztzentrum Eppendorf, Studien GbR	Hamburg		Germany	20249
190	Diakovere Henriettenstift, Frauenklinik	Hannover		Germany	30559
191	Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie	Hannover		Germany	30625
192	Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg	Heidelberg		Germany	69120
193	Praxis Köppler, Heymann, Weide, Thomalla; Fä Für Innere Medizin	Koblenz		Germany	56068
194	Dres. Andreas Köhler und Roswitha Fuchs	Langen		Germany	63225
195	St. Elisabeth-Krankenhaus, Senologie/Brustzentrum	Leipzig		Germany	04277
196	Onkologische Schwerpunktpraxis Lübeck	Lübeck		Germany	23562
197	Klinikum Magdeburg gGmbH, Brustzentrum; Klinik für Frauenheilkunde und Geburtshilfe	Magdeburg		Germany	39130
198	Universitätsklinikum Mannheim; Frauenklinik	Mannheim		Germany	68167
199	Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt	München		Germany	80337
200	Gemeinschaftspraxis für Hämatologie und Onkologie	Münster		Germany	48153
201	Studienzentrum Onkologie Ravensburg GbR; Onkologie Ravensburg	Ravensburg		Germany	88212
202	Universitätsfrauen- und Poliklinik am Klinikum Suedstadt	Rostock		Germany	18059
203	Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie	Trier		Germany	54290
204	Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis	Troisdorf		Germany	53840
205	Universitätsklinik Tübingen; Frauenklinik	Tübingen		Germany	72076
206	Lahn-Dill Kliniken GmbH Klinikum Wetzlar Gynäkologie/Geburtshilfe	Wetzlar		Germany	35578
207	Marien-Hospital Witten; Frauenklinik Brustzentrum	Witten		Germany	58452
208	Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine	Athens		Greece	115 22
209	Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine	Athens		Greece	115 22
210	University Hospital of Larissa;Department of Medical Oncology	Larissa		Greece	411 10
211	Euromedical General Clinic of Thessaloniki; Oncology Department	Thessaloniki		Greece	546 45
212	Pamela Youde Nethersole Eastern Hospital; Clinical Oncology	Hong Kong		Hong Kong
213	Princess Margaret Hospital; Oncology	Hong Kong		Hong Kong
214	Queen Mary Hospital; Dept of Medicine	Hong Kong		Hong Kong
215	Szent Margit Hospital; Dept. of Oncology	Budapest		Hungary	1032
216	Honvédelmi Minisztérium Állami Egészségügyi Központ; Onkológiai Osztály; Oncology department	Budapest		Hungary	1062
217	Uzsoki Utcai Korhaz; Onkoradiológiai Osztály	Budapest		Hungary	1145
218	Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet	Pécs		Hungary	7623
219	Davidof Center - Rabin Medical Center	Petah Tiqwa		Israel	49100
220	Chaim Sheba Medical Center; Oncology Dept	Ramat Gan		Israel	5262100
221	Tel Aviv Sourasky Medical Ctr; Oncology	Tel Aviv		Israel	6423906
222	Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale	Napoli	Campania	Italy	80131
223	IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica	Meldola	Emilia-Romagna	Italy	47014
224	IRCCS Istituto Regina Elena (IFO); Oncologia Medica B	Roma	Lazio	Italy	00144
225	A.O. Universitaria S. Martino Di Genova	Genova	Liguria	Italy	16132
226	Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina	Brescia	Lombardia	Italy	25123
227	Istituto Europeo Di Oncologia	Milano	Lombardia	Italy	20141
228	ASST DI MONZA; Oncologia Medica	Monza	Lombardia	Italy	20900
229	Fondazione del Piemonte per l'Oncologia (IRCCS)	Candiolo	Piemonte	Italy	10060
230	Humanitas Centro Catanese Di Oncologia; Oncologia Medica	Misterbianco (CT)	Sicilia	Italy	95045
231	Ospedale Civile - Livorno	Livorno	Toscana	Italy	57124
232	Ospedale Sacro Cuore Don Calabria	Negrar	Veneto	Italy	37024
233	IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II	Padova	Veneto	Italy	35128
234	Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza	Vicenza	Veneto	Italy	36100
235	Nagoya University Hospital	Aichi		Japan	466-8560
236	Chiba Cancer Center	Chiba		Japan	260-8717
237	National Cancer Center Hospital East	Chiba		Japan	277-8577
238	National Hospital Organization Kyushu Cancer Center	Fukuoka		Japan	811-1395
239	Fukushima Medical University Hospital	Fukushima		Japan	960-1295
240	Hiroshima City Hiroshima Citizens Hospital	Hiroshima		Japan	730-8518
241	Hiroshima University Hospital	Hiroshima		Japan	734-8551
242	National Hospital Organization Hokkaido Cancer Center	Hokkaido		Japan	003-0804
243	Hyogo Cancer Center	Hyogo		Japan	673-0021
244	University of Tsukuba Hospital	Ibaraki		Japan	305-8576
245	Sagara Hospital	Kagoshima		Japan	892-0833
246	St. Marianna University Hospital	Kanagawa		Japan	216-8511
247	Kanagawa Cancer Center	Kanagawa		Japan	241-8515
248	Tokai University Hospital	Kanagawa		Japan	259-1193
249	Kumamoto University Hospital	Kumamoto		Japan	860-8556
250	Niigata Cancer Center Hospital	Niigata		Japan	951-8566
251	Naha-nishi Clinic	Okinawa		Japan	901-0154
252	National Hospital Organization Osaka National Hospital	Osaka		Japan	540-0006
253	Osaka International Cancer Institute	Osaka		Japan	541-8567
254	Saitama Cancer Center	Saitama		Japan	362-0806
255	National Cancer Center Hospital	Tokyo		Japan	104-0045
256	St. Luke's Internat. Hospital, Breast Surgical Oncology	Tokyo		Japan	104-8560
257	Juntendo University Hospital	Tokyo		Japan	113-8431
258	The Cancer Institute Hospital of JFCR	Tokyo		Japan	135-8550
259	Showa University Hospital	Tokyo		Japan	142-8666
260	Chungbuk National University Hospital	Cheongju-si		Korea, Republic of	28644
261	Kyungpook National University Medical Center	Daegu		Korea, Republic of	41404
262	National Cancer Center	Goyang-si		Korea, Republic of	10408
263	Ajou University Medical Center	Gyeonggi-do		Korea, Republic of	16499
264	Gachon University Gil Medical Center	Incheon		Korea, Republic of	21565
265	Seoul National University Bundang Hospital	Seongnam-si		Korea, Republic of	13605
266	Korea University Anam Hospital	Seoul		Korea, Republic of	02841
267	Seoul National University Hospital	Seoul		Korea, Republic of	03080
268	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	03722
269	Asan Medical Center	Seoul		Korea, Republic of	05505
270	Gangnam Severance Hospital	Seoul		Korea, Republic of	06273
271	Samsung Medical Center	Seoul		Korea, Republic of	06351
272	Seoul St Mary's Hospital	Seoul		Korea, Republic of	06591
273	Ewha Womans University Mokdong Hospital	Seoul		Korea, Republic of	07985
274	Korea University Guro Hospital	Seoul		Korea, Republic of	08308
275	Ulsan University Hosiptal	Ulsan		Korea, Republic of	44033
276	Health Pharma Professional Research	Cdmx	Mexico CITY (federal District)	Mexico	03100
277	Centro Medico Dalinde	Cdmx	Mexico CITY (federal District)	Mexico	06760
278	Christus Muguerza Clinica Vidriera	Monterrey	Nuevo LEON	Mexico	64570
279	Oncologico Potosino	San Luis Potosí	SAN LUIS Potosi	Mexico	78209
280	Auckland City Hospital; Clinical Oncology	Auckland		New Zealand	1023
281	Waikato Breast Cancer Trust	Hamilton		New Zealand	3240
282	Centro Medico Monte Carmelo	Arequipa		Peru	04001
283	Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel	Lima		Peru	15088
284	Oncosalud Sac; Oncología	Lima		Peru	41
285	Instituto Nacional de Enfermedades Neoplasicas	Lima		Peru	Lima 34
286	Clinica Ricardo Palma	San Isidro		Peru	Lima 27
287	Instituto Regional de Enfermedades Neoplasicas - IREN Norte	Trujillo		Peru	13014
288	Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii	Gdańsk		Poland	80-214
289	Szpital Morski im. PCK; Poradnia Onkologiczna	Gdynia		Poland	81-519
290	Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna	Lodz		Poland	90-242
291	Woj. Wielospecjalistyczne Centrum Onkol. i Traumat. im.M.Kopernika; Woj. Przychodnia Onkologiczna	Lodz		Poland	93-513
292	Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr	Warszawa		Poland	02-781
293	IPO de Coimbra; Servico de Oncologia Medica	Coimbra		Portugal	3000-075
294	IPO de Lisboa; Servico de Oncologia Medica	Lisboa		Portugal	1099-023
295	Hospital da Luz; Departamento de Oncologia Medica	Lisboa		Portugal	1500-650
296	Centro Hospitalar Lisboa Norte	Lisboa		Portugal
297	IPO do Porto; Servico de Oncologia Medica	Porto		Portugal	4200-072
298	Respublikanskiy Onkologicheskiy Dispanser	Saransk	Mordovija	Russian Federation	430032
299	SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"	Moskva	Moskovskaja Oblast	Russian Federation	111123
300	Ryazan Regional clinical oncology dispensary	Ryazan	Rjazan	Russian Federation	390011
301	Chelyabinsk region oncology dispensary	Chelyabinsk		Russian Federation	454087
302	Podolsk City Clinical Hospital; Hematology	Podolsk		Russian Federation	142100
303	GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)	Saint Petersburg		Russian Federation	197758
304	Multidisciplinary clinic Reaviz	Samara		Russian Federation	443011
305	Regional Clinical Oncology Hospital	Yaroslavl		Russian Federation	150040
306	Corporacio Sanitaria Parc Tauli; Servicio de Oncologia	Sabadell	Barcelona	Spain	8208
307	Hospital de Donostia; Servicio de Oncologia Medica	San Sebastian	Guipuzcoa	Spain	20080
308	Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia	A Coruña	LA Coruña	Spain	15006
309	Hospital del Mar; Servicio de Oncologia	Barcelona		Spain	08003
310	Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica	Barcelona		Spain	08028
311	Vall d´Hebron Institute of Oncology (VHIO), Barcelona	Barcelona		Spain	08035
312	Hospital Duran i Reynals; Oncologia	Barcelona		Spain	08907
313	Hospital Lucus Augusti; Servicio de Oncologia	Lugo		Spain	27003
314	Hospital General Universitario Gregorio Marañon; Servicio de Oncologia	Madrid		Spain	28007
315	Centro Oncologico MD Anderson Internacional; Servicio de Oncologia	Madrid		Spain	28033
316	Hospital Ramon y Cajal; Servicio de Oncologia	Madrid		Spain	28034
317	Hospital Clinico San Carlos; Servicio de Oncologia	Madrid		Spain	28040
318	HM Sanchinarro - CIOCC; Servicio de Oncologia	Madrid		Spain	28050
319	Hospital Universitario Virgen del Rocio; Servicio de Oncologia	Sevilla		Spain	41013
320	Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia	Valencia		Spain	46010
321	Hospital Quiron Salud Valencia	Valencia		Spain	46010
322	China Medical University Hospital; Surgery	Taichung		Taiwan	404
323	National Cheng Kung Uni Hospital; Dept of Hematology and Oncology	Tainan		Taiwan	704
324	VETERANS GENERAL HOSPITAL; Department of General Surgery	Taipei		Taiwan	00112
325	National Taiwan Uni Hospital; Dept of Oncology	Taipei		Taiwan	100
326	Mackay Memorial Hospital; Dept of Surgery	Taipei		Taiwan	104
327	Chang Gung Memorial Hosipital at Linkou	Taoyuan City		Taiwan	333
328	Chulalongkorn Hospital, Faculty of Medicine; Dept. of Medicine	Bangkok		Thailand	10330
329	Rajavithi Hospital; Division of Medical Oncology	Bangkok		Thailand	10400
330	Ramathibodi Hospital; Medicine/Oncology	Bangkok		Thailand	10400
331	Maharaj Nakorn Chiang Mai Hosp; Surgery/Oncology	Chang Mai		Thailand	50200
332	Songklanagarind Hospital; Department of Oncology	Songkhla		Thailand	90110
333	Adana Baskent University Hospital; Medical Oncology	Adana		Turkey	01120
334	Ankara City Hospital	Ankara		Turkey	06490
335	Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi	Edirne		Turkey	22030
336	Medipol University MF; Oncology Department	Istanbul		Turkey	34214
337	Katip Celebi University Ataturk Training and Research Hospital; Oncology	Izmir		Turkey	35360
338	Kocaeli University Faculty of Medicine; Medical oncology	Izmit		Turkey	31380
339	Medeniyet University Goztepe Training and Research Hospital.	Kadiköy		Turkey	34722
340	Antalya Memorial Hastanesi; Onkoloji	Kepez		Turkey	07020
341	Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department	Malatya		Turkey	44280
342	Mersin Medical Park Hospital	Mezi̇tli̇		Turkey	33200
343	19 Mayis University Medical Faculty; Medical Oncology Department	Samsun		Turkey	55139
344	Hacettepe Uni Medical Faculty Hospital; Oncology Dept	Sihhiye/Ankara		Turkey	06230
345	Municipal Institution City Clinical Hospital #4 of Dnipro City Council	Dnipropetrovsk	Katerynoslav Governorate	Ukraine	49102
346	Uzhgorod Central City Clinical Hospital	Uzhhorod	Katerynoslav Governorate	Ukraine	88000
347	SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU	Kharkiv	Kharkiv Governorate	Ukraine	61018
348	Ivano-Frankivsk Regional Oncology Center	Ivano-Frankivsk		Ukraine	76018
349	ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department	Kryvyi Rih		Ukraine	50048
350	Sumy Regional Clinical Onc Ctr	Sumy		Ukraine	40005
351	Royal Sussex County Hospital	Brighton		United Kingdom	BN2 5BE
352	Velindre Cancer Centre; Clinical Trials Unit	Cardiff		United Kingdom	CF14 2TL
353	Coventry and Warwickshire Partnership NHS Trust	Coventry		United Kingdom	CV6 6NY
354	Leicester Royal Infirmary; Infectious Disease Unit	Leicester		United Kingdom	LE1 5WW
355	University College London Hospital	London		United Kingdom	NW1 - 2PG
356	Royal Free Hospital	London		United Kingdom	NW3 2QS
357	Guys & St Thomas Hospital; Department of Oncology	London		United Kingdom	SE1 9RT
358	Royal Marsden Hosp NHS Fnd; Breast Unit	London		United Kingdom	SW3 6JJ
359	Maidstone Hospital; Kent Oncology Centre	Maidstone		United Kingdom	ME16 9QQ
360	Nottingham City Hospital	Nottingham		United Kingdom	NG5 1PB
361	Peterborough City Hospital; Oncology Research Department 018	Peterborough		United Kingdom	PE3 9GZ
362	Derriford Hospital	Plymouth		United Kingdom	PL6 8DH
363	Royal Stoke University Hospital	Stoke-on-Trent		United Kingdom	ST4 6QG
364	Royal Marsden Hosp NHS Fnd; Medicine - Breast Unit	Sutton		United Kingdom	SM2 5PT
365	Royal Cornwall Hospital	Truro		United Kingdom	TR1 3LQ

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT04546009
• Other Study ID Numbers: BO41843; 2020-000119-66
• First Posted: Sep 11, 2020
• Last Update Posted: Aug 9, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Letrozole; Palbociclib

Study Results

No Results Posted as of Aug 9, 2022