PATINA: Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer

• Sponsor: Alliance Foundation Trials, LLC. (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02947685
• Collaborator: Pfizer (Industry), German Breast Group (Other), Fondazione Michelangelo (Other), PrECOG, LLC. (Other), Breast Cancer Trials, Australia and New Zealand (Other), Syneos Health (Other), SOLTI Breast Cancer Research Group (Other), UNICANCER (Other)
• Enrollment: 496
• Locations: 107
• Arms: 2
• Anticipated Duration (Months): 105.3
• Patients Per Site: 4.6
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.

Condition or Disease	Intervention/Treatment	Phase
HER-2 Positive Breast Cancer; Estrogen Receptor Positive Breast Cancer	Drug: palbociclib; Drug: trastuzumab; Drug: pertuzumab; Drug: letrozole; Drug: Anastrozole; Drug: Exemestane; Drug: Fulvestrant	Phase 3

Detailed Description

Subjects will be randomized into one of two treatment arms following minimum of 4 and maximum of 8 cycles of induction treatment with anti-HER2 therapy. Arm A subjects will receive the experimental therapy, palbociclib, in addition to their current anti-HER2 therapy and endocrine therapy. Arm B subjects will continue to receive the anti-HER2 therapy. It is expected that the addition of palbociclib to the first-line treatment of HER2 disease will delay the onset of therapeutic resistance and ultimately prolong the survival of patients with metastatic breast cancer. The study is designed to treat the subset of patients with HER2+ disease who are also hormone receptor positive (HR+). It is also expected that palbociclib will modulate the endocrine resistance in HER2+/HR+ disease and potentiate the benefits of anti-HER2 therapy. Lastly, the current study includes a comprehensive molecular characterization of the disease at study entrance which will allow us to investigate the benefits of palbociclib in subsets of HER2+/HR+ disease such as PIK3CA mutant.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 496 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy After Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer
• Actual Study Start Date: Jun 21, 2017
• Anticipated Primary Completion Date: May 31, 2023
• Anticipated Study Completion Date: Mar 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A Palbociclib 125 mg daily + AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt) until confirmed disease progression	Drug: palbociclib; o Starting dose: 125 mg capsule taken orally once per day for 21 days followed by 7 days off to complete 28 day cycle. Dose reductions: 100 mg, 75 mg. allowed. Number of Cycles: until progression or unacceptable toxicity develops; Other Names: Ibrance ; Drug: trastuzumab; Patients must have received a minimum of 4 and maximum of 8 cycles of induction therapy prior to randomization to Arm A or B, at which point they will continue on antiHER2 therapy and endocrine therapy, with or without palbociclib. Trastuzumab dosing will be determined based on a loading dose of 8mg trastuzumab/kg body weight for Q3WK dosing schedules or a maintenance dose of 6mg/kg trastuzumab/kg dosing weight for Q3WK dosing schedules. Loading dose will be administered on Cycle 1, Day 1.; Other Names: Herceptin ; Drug: pertuzumab; Patients must have received a minimum of 4 and maximum of 8 cycles of induction therapy prior to randomization to Arm A or B, at which point they will continue on antiHER2 therapy and endocrine therapy, with or without palbociclib.Pertuzumab will be administered at a loading dose of 840 mg infusion and then at a maintenance dose of 420 mg q3wks. If patient is within 5 weeks of receiving loading dose at Cycle 1, Day 1, patient may start with maintenance dose of 420 mg.; Other Names: Perjeta ; Drug: letrozole; There are several allowed endocrine treatment agents for Arm A and Arm B of this study. Administration is performed on an outpatient, self-administration basis according to local requirements and local standard practice. Endocrine treatment may have started before the patient enters the study. Agents will be administered at the discretion of principal investigator as well as according to standard institutional or regional practice. Recommended dosing regimen for letrozole oral therapy is 2.5 mg orally, once a day.; Other Names: Femara ; Drug: Anastrozole; There are several allowed endocrine treatment agents for Arm A and Arm B of this study. Administration is performed on an outpatient, self-administration basis according to local requirements and local standard practice. Endocrine treatment may have started before the patient enters the study. Agents will be administered at the discretion of principal investigator as well as according to standard institutional or regional practice. Recommended dosing regimen for anastrozole is 1 mg orally, once a day.; Other Names: Arimidex ; Drug: Exemestane; There are several allowed endocrine treatment agents for Arm A and Arm B of this study. Administration is performed on an outpatient, self-administration basis according to local requirements and local standard practice. Endocrine treatment may have started before the patient enters the study. Agents will be administered at the discretion of principal investigator as well as according to standard institutional or regional practice. Recommended dosing regimen for exemestane is 25 mg orally, once a day.; Other Names: Aromasin ; Drug: Fulvestrant; There are several allowed endocrine treatment agents for Arm A and Arm B of this study. Administration is performed on an outpatient, self-administration basis according to local requirements and local standard practice. Endocrine treatment may have started before the patient enters the study. Agents will be administered at the discretion of principal investigator as well as according to standard institutional or regional practice. Recommended dosing regimen for Fulvestrant is 250 mg injections on Day 1 and Day 15 of Cycle 1, and q4weeks thereafter.; Other Names: Faslodex
Active Comparator: Arm B AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant) until confirmed disease progression	Drug: pertuzumab; Patients must have received a minimum of 4 and maximum of 8 cycles of induction therapy prior to randomization to Arm A or B, at which point they will continue on antiHER2 therapy and endocrine therapy, with or without palbociclib.Pertuzumab will be administered at a loading dose of 840 mg infusion and then at a maintenance dose of 420 mg q3wks. If patient is within 5 weeks of receiving loading dose at Cycle 1, Day 1, patient may start with maintenance dose of 420 mg.; Other Names: Perjeta ; Drug: letrozole; There are several allowed endocrine treatment agents for Arm A and Arm B of this study. Administration is performed on an outpatient, self-administration basis according to local requirements and local standard practice. Endocrine treatment may have started before the patient enters the study. Agents will be administered at the discretion of principal investigator as well as according to standard institutional or regional practice. Recommended dosing regimen for letrozole oral therapy is 2.5 mg orally, once a day.; Other Names: Femara ; Drug: Anastrozole; There are several allowed endocrine treatment agents for Arm A and Arm B of this study. Administration is performed on an outpatient, self-administration basis according to local requirements and local standard practice. Endocrine treatment may have started before the patient enters the study. Agents will be administered at the discretion of principal investigator as well as according to standard institutional or regional practice. Recommended dosing regimen for anastrozole is 1 mg orally, once a day.; Other Names: Arimidex ; Drug: Exemestane; There are several allowed endocrine treatment agents for Arm A and Arm B of this study. Administration is performed on an outpatient, self-administration basis according to local requirements and local standard practice. Endocrine treatment may have started before the patient enters the study. Agents will be administered at the discretion of principal investigator as well as according to standard institutional or regional practice. Recommended dosing regimen for exemestane is 25 mg orally, once a day.; Other Names: Aromasin ; Drug: Fulvestrant; There are several allowed endocrine treatment agents for Arm A and Arm B of this study. Administration is performed on an outpatient, self-administration basis according to local requirements and local standard practice. Endocrine treatment may have started before the patient enters the study. Agents will be administered at the discretion of principal investigator as well as according to standard institutional or regional practice. Recommended dosing regimen for Fulvestrant is 250 mg injections on Day 1 and Day 15 of Cycle 1, and q4weeks thereafter.; Other Names: Faslodex

Outcome Measures

Primary Outcome Measures

1. Progression-free survival (PFS) as assessed by Investigator [24 months]

Secondary Outcome Measures

1. Overall Survival (OS) [24 months]

   Defined as time from date of randomization to date of death due to any cause

2. 3 and 5 year survival probabilities [24 months]

   Survival probabilities will be estimated using the Kaplan-Meier method

3. Objective Response Rate (OR: CR or PRR) [24 months]

   Defined as complete response (CR) or partial response (PR) according to RECIST v1.1

4. Duration of Response (DOR) [24 months]

   Defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death from any cause, whichever occurs first

5. Clinical Benefit Rate (CBR: CR or PR or SD ≥ 24 weeks [24 months]

   The Clinical Benefit Rate (CBR) on each treatment arm will be estimated by dividing the number of patients with CR, PR, or SD/Non-CR and Non-PD (for patients with measurable disease) ≥ 24 weeks by the number of patients randomized to the treatment arm.

6. Safety: Type incidence and severity (as graded by NCI CTCAE v 4.0) [24 months]

   Seriousness and attribution to the study medications of AEs and any laboratory abnormalities

7. Patient Reported Outcomes [24 months]

   Time to symptom progression (FACT-B PFB-TOI), breast cancer specific health treatment related quality of life and general health status

Other Outcome Measures

1. Trough Plasma concentration of palbociclib, trastuzumab and pertuzumab [Palbociclib PK assessment: Day 22, Cycle 1, No; Pertuzumab, Trastuzumab PK assessment: Day 1, Cycle 4]

   only for patients enrolled in the US

2. PIK3CA genotype assessed in circulating cfDNA [Day 1, Cycle 1, Day 1, Cycle 4, End of Treatment, approx 24 months]

   Progression Free Survival (PFS) based upon investigator assessment of progression between patients in the two treatment arms in the subset of patients with tumors bearing a PIK3CA mutation.

3. Tumor tissue biomarkers including genes, proteins, and RNA expression [Baseline]

   Will evaluate baseline tumor and blood-based markers as predictors of benefit from the addition of palbociclib to anti-HER2 therapy plus endocrine therapy

Eligibility Criteria

Criteria

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

Inclusion Criteria (Preliminary Screening)

1. Signed Preliminary Screening Informed Consent Form obtained prior to any study specific assessments and procedures

2. Age ≥18 years (or per national guidelines)

3. Patients must have histologically confirmed invasive breast cancer that is metastatic or not amenable for resection or radiation therapy with curative intent. Histological documentation of metastatic/recurrent breast cancer is not required if there is unequivocal evidence for recurrence of the breast cancer.

4. Patients must have histologically confirmed HER2+ and hormone receptor positive (ER+ and/or PR+), metastatic breast cancer. ER, PR and HER2 measurements should be performed according to institutional guidelines, in a CLIA-approved setting in the US or certified laboratories for Non-US regions. Cut-off values for positive/negative staining should be in accordance with current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines.

5. Patients must agree to provide a representative formalin-fixed paraffin-embedded (FFPE) tumor tissue block (preferred) from primary breast or metastatic site (archival) OR at least 15 freshly cut unstained slides from such a block, along with a pathology report documenting HER2 positivity and hormone receptor positivity.

6. Patients should be willing to provide a representative tumor specimen obtained from recently biopsied metastatic disease if clinically feasible. This is recommended but optional tissue.

Inclusion Criteria (Randomization Screening)

1. Signed Main Informed Consent Form obtained prior to any study specific assessments and procedures

2. Age ≥ 18 years (or per national guidelines)

3. ECOG performance status 0-1

4. Patients must be able and willing to swallow and retain oral medication without a condition that would interfere with enteric absorption.

5. Serum or urine pregnancy test must be negative within 7 days of randomization in women of childbearing potential. Pregnancy testing does not need to be pursued in patients who are judged as postmenopausal before randomization, as determined by local practice, or who have undergone bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation. Women of childbearing potential and male patients randomized into the study must use adequate contraception for the duration of protocol treatment which is 6 months after the last treatment with palbociclib if they are in Arm A and for 7 months after last treatment with trastuzumab if in either Arm A or Arm B Adequate contraception is defined as one highly effective form (i.e. abstinence, (fe)male sterilization OR two effective forms (e.g. non-hormonal IUD and condom / occlusive cap with spermicidal foam / gel / film / cream / suppository).

6. Resolution of all acute toxic effects of prior induction anti-HER2-based chemotherapy regimen to NCI CTCAE version 4.0 Grade ≤1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion) 12 weeks between last dose of chemotherapy-anti-HER2therapy and randomization are allowed. Endocrine therapy could start before study randomization.

7. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Prior Treatment Specifics

1. Patients may or may not have received neo/adjuvant therapy, but must have a disease-free interval from completion of anti-HER2 therapy to metastatic diagnosis ≥6 months.

2. Patients must have received an acceptable, standard, chemotherapy containing anti-HER2 based induction therapy for the treatment of metastatic breast cancer prior to study enrollment. For this study, chemotherapy is limited to a taxane or vinorelbine (only for trastuzumab-based regimen). Eligible patients are expected to have completed 6 cycles of chemotherapy containing anti-HER2-therapy treatment. A minimum of 4 cycles of treatment is acceptable for patients experiencing significant toxicity associated with treatment as long as they are without evidence of disease progression (i.e. CR, PR or SD). The maximum number of cycles is 8. Patients can randomize immediately following completion of their induction therapy, or for those who have already completed induction, a gap of 12 weeks between their last infusion/dose of induction therapy and the C1D1 visit is permitted. Patients are eligible provided they are without evidence of disease progression by local assessment (i.e. CR, PR or SD).

3. Patients with a history or presence of asymptomatic CNS metastases are eligible, provided they meet all of the following criteria:

• Disease outside the CNS is present.

• No evidence of interim progression between the completion of induction therapy and the screening radiographic study

• No history of intracranial hemorrhage or spinal cord hemorrhage

• Not requiring anti-convulsants for symptomatic control

• Minimum of 3 weeks between completion of CNS radiotherapy and Cycle 1 Day 1 and recovery from significant (Grade ≥ 3) acute toxicity with no ongoing requirement for corticosteroid

Baseline Body Function Specifics

1. Absolute neutrophil count ≥ 1,000/mm3

2. Platelets ≥ 100,000/mm3

3. Hemoglobin ≥ 10g/dL

4. Total serum bilirubin ≤ ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range in patients with documented Gilbert's Syndrome.

5. Aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) ≤ 3 × institutional ULN (≤5 x ULN if liver metastases are present).

6. Serum creatinine below the upper limit of normal (ULN) of the institutional normal range or creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with serum creatinine levels above institutional ULN.

7. Left ventricular ejection fraction (LVEF) ≥ 50% at baseline as determined by either ECHO or MUGA

Exclusion Criteria (Randomization)

1. Concurrent therapy with other Investigational Products.

2. Prior therapy with any CDK 4/6 inhibitor.

3. History of allergic reactions attributed to compounds of chemical or biologic composition similar to palbociclib.

4. Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A isoenzymes within 7 days of randomization (see Section 8.6.3 for list of strong inhibitors or inducers of CYP3A isoenzymes).

5. Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes, or psychiatric illness/social situations that would limit compliance with study requirements. Ability to comply with study requirements is to be assessed by each investigator at the time of screening for study participation.

6. Pregnant women, or women of childbearing potential without a negative pregnancy test (serum or urine) within 7 days prior to randomization, irrespective of the method of contraception used, are excluded from this study because the effect of palbociclib on a developing fetus is unknown. Breastfeeding must be discontinued prior to study entry.

7. Patients on combination antiretroviral therapy, i.e. those who are HIV-positive, are ineligible because of the potential for pharmacokinetic interactions or increased immunosuppression with palbociclib.

8. QTc interval >480 msec, Brugada syndrome or known history of QTc prolongation or Torsade de Pointes.

9. Patients with clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSF	San Francisco	California	United States	94115
2	Georgetown University Medical Center	Washington	District of Columbia	United States	20007
3	Baycare Healthcare (Morton Plant Mease)	Clearwater	Florida	United States	33756
4	Memorial Healthcare System	Hollywood	Florida	United States	33021
5	University of Miami	Miami	Florida	United States	33136
6	Florida Hospital	Orlando	Florida	United States	32804
7	Emory University	Atlanta	Georgia	United States	30322
8	University of Illinois at Chicago	Chicago	Illinois	United States	60612
9	The University of Chicago Medical Center	Chicago	Illinois	United States	60637
10	Ingalls Memorial Hospital	Harvey	Illinois	United States	60426
11	Cancer Center of Kansas	Wichita	Kansas	United States	67214
12	Ochsner Medical Center Jefferson	New Orleans	Louisiana	United States	70121
13	New England Cancer Specialists	Scarborough	Maine	United States	04074
14	Anne Arundel Medical Center	Annapolis	Maryland	United States	21401
15	University of Maryland - Greenebaum Comprehensive Cancer Center	Baltimore	Maryland	United States	21201
16	Johns Hopkins University/Sidney Kimmel Cancer Center	Baltimore	Maryland	United States	21287
17	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
18	Lowell General Hospital	Lowell	Massachusetts	United States	01854
19	Michigan Cancer Research Consortium (St. Joseph Mercy Hospital	Ann Arbor	Michigan	United States	48106
20	West Michigan Cancer Center	Grand Rapids	Michigan	United States	49503
21	Metro-Minnesota NCI Community Oncology Research Program	Minneapolis	Minnesota	United States	55416
22	Mayo Clinic, Rochester, MN	Rochester	Minnesota	United States	55905
23	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
24	Nebraska Methodist Hospital	Omaha	Nebraska	United States	68114
25	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198
26	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
27	Hackensack Medical Center	Hackensack	New Jersey	United States	07601
28	The Valley Hospital, Okonite Research Center	Paramus	New Jersey	United States	07652
29	New Mexico Cancer Care Alliance	Albuquerque	New Mexico	United States	87131
30	Duke Cancer Institute	Durham	North Carolina	United States	27710
31	First Health of the Carolinas Cancer Center	Pinehurst	North Carolina	United States	28374
32	Ohio State University	Columbus	Ohio	United States	43210
33	Legacy Good Samaritan Hospital	Portland	Oregon	United States	97210
34	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19106
35	Lexington Medical Center	West Columbia	South Carolina	United States	29169
36	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37204
37	MD Anderson	Houston	Texas	United States	77030
38	Huntsman Cancer Institute, University of Utah	Salt Lake City	Utah	United States	84112
39	Monash Health	Clayton		Australia
40	St. Vincent's Hospital, Sydney Kinghorn Cancer Centre	Darlinghurst		Australia
41	The Canberra Hospital	Garran		Australia
42	Peter MacCallum Cancer Centre, Royal Melbourne Hospital	Melbourne		Australia
43	Breast Cancer Research Centre-WA	Nedlands		Australia
44	Icon Cancer Care	South Brisbane		Australia
45	Mater Cancer Care Centre	South Brisbane		Australia
46	Calvary Mater Newcastle Hospital	Waratah		Australia
47	Westmead Hospital	Westmead		Australia
48	Institut de Cancérologie de l'Ouest, site Paul Papin	Angers		France
49	Institut Sainte Catherine	Avignon		France
50	Institut Bergonié	Bordeaux		France
51	Centre Francois Baclesse	Caen		France
52	Centre Hospitalier Cholet	Cholet		France
53	Centre Jean Perrin	Clermont-Ferrand		France
54	Centre Georges François Leclerc	Dijon		France
55	CHU de Limoges	Limoges		France
56	Centre Léon Bérard	Lyon		France
57	Institut Paoli Calmettes	Marseille		France
58	Centre Antoine Lacassagne	Nice		France
59	Hôpital Saint Louis	Paris		France
60	Institut Curie Site Paris	Paris		France
61	Tenon Oncologie Médicale - APHP	Paris		France
62	Centre CARIO-HPCA	Plerin Cedex		France
63	Institut Jean Godinot	Reims		France
64	Centre Henri Becquerel	Rouen		France
65	Institut Curie Site Saint Cloud	Saint-Cloud		France
66	Institut de Cancérologie Lucien Neuwirth	Saint-Priest-en-Jarez		France
67	Centre Paul Strauss	Strasbourg		France
68	Intitut Claudius Regaud	Toulouse		France
69	Gustave Roussy	Villejuif		France
70	Praxisklinik Krebsheilkunde für Frauen	Berlin		Germany
71	Studiengesellschaft Onkologie Bielefeld	Bielefeld		Germany
72	Marienhospital Bottrop	Bottrop		Germany
73	Luisenkrankenhaus Düsseldorf	Düsseldorf		Germany
74	Universitätsklinikum Düsseldorf, Klinik für Frauenheilkunde & Geburtshilfe	Düsseldorf		Germany
75	Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft GmbH	Essen		Germany
76	Agaplesion Markus Krankenhaus	Frankfurt		Germany
77	Sana-Klinikum Hameln	Hameln		Germany
78	Diakovere Henriettenstift Frauenklinik	Hannover		Germany
79	Vidia Christliche Kliniken Karlsruhe Vincentius-Diakonissen-Kliniken gAG Frauenklinik	Karlsruhe		Germany
80	UKSH, Klinik für Gynäkologie und Geburtshilfe	Kiel		Germany
81	St. Elisabeth Krankenhaus	Köln		Germany
82	Praxis Prof. Nitz im Brustzentrum Niederrhein	Munster		Germany
83	Universitätsklinikum Münster	Münster		Germany
84	Univ. Klinikum Oldenburg AÖR Hämatologie/Onkologie	Oldenburg		Germany
85	Leopoldina-Krankenhaus Schweinfurt	Schweinfurt		Germany
86	HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie	Wiesbaden		Germany
87	Ospedale San Raffaele	Segrate		Italy
88	Auckland City Hospital Cancer and Blood Research	Auckland		New Zealand
89	Hospital Clínic de Barcelona	Barcelona		Spain
90	Hospital General de Catalunya	Barcelona		Spain
91	Hospital Universitari Vall d'Hebron	Barcelona		Spain
92	ICO L'Hospitalet	Barcelona		Spain
93	Hospital Universitario 12 de Octubre	Madrid		Spain
94	Hospital Universitario de Fuenlabrada	Madrid		Spain
95	Hospital Universitario Fundación Alcorcón	Madrid		Spain
96	Hospital Universitario Fundación Jiménez Díaz	Madrid		Spain
97	Hospital Universitario La Paz	Madrid		Spain
98	Hospital Universitario Severo Ochoa	Madrid		Spain
99	MD Anderson Cancer Center Spain	Madrid		Spain
100	Hospital Universitario Virgen de la Arrixaca	Murcia		Spain
101	Hospital Regional Universitario de Málaga	Málaga		Spain
102	Complejo Hospitalario de Navarra	Navarro		Spain
103	Hospital Universitario de Salamanca	Salamanca		Spain
104	Complejo Hospitalario Univ. De Santiago	Santiago		Spain
105	Hospital Quirón Sagrado Corazón	Seville		Spain
106	Hospital Sant Joan de Reus	Tarragona		Spain
107	Hospital Clínico Universitario de Valencia	Valencia		Spain

Sponsors and Collaborators

• Alliance Foundation Trials, LLC.
• Pfizer
• German Breast Group
• Fondazione Michelangelo
• PrECOG, LLC.
• Breast Cancer Trials, Australia and New Zealand
• Syneos Health
• SOLTI Breast Cancer Research Group
• UNICANCER

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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• Cristofanilli M, Turner NC, Bondarenko I, Ro J, Im SA, Masuda N, Colleoni M, DeMichele A, Loi S, Verma S, Iwata H, Harbeck N, Zhang K, Theall KP, Jiang Y, Bartlett CH, Koehler M, Slamon D. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 2016 Apr;17(4):425-439. doi: 10.1016/S1470-2045(15)00613-0. Epub 2016 Mar 3. Erratum in: Lancet Oncol. 2016 Apr;17 (4):e136. Lancet Oncol. 2016 Jul;17 (7):e270.
• Early Breast Cancer Trialists' Collaborative Group (EBCTCG), Peto R, Davies C, Godwin J, Gray R, Pan HC, Clarke M, Cutter D, Darby S, McGale P, Taylor C, Wang YC, Bergh J, Di Leo A, Albain K, Swain S, Piccart M, Pritchard K. Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100,000 women in 123 randomised trials. Lancet. 2012 Feb 4;379(9814):432-44. doi: 10.1016/S0140-6736(11)61625-5. Epub 2011 Dec 5.
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• Responsible Party: Alliance Foundation Trials, LLC.
• ClinicalTrials.gov Identifier: NCT02947685
• Other Study ID Numbers: AFT-38
• First Posted: Oct 28, 2016
• Last Update Posted: Mar 18, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Alliance Foundation Trials, LLC.: breast cancer; malignant tumor of the breast; HER2+; HR+; metastatic breast cancer
• Additional relevant MeSH terms: Breast Neoplasms; Trastuzumab; Pertuzumab; Letrozole; Fulvestrant; Palbociclib; Anastrozole; Exemestane

Study Results

No Results Posted as of Mar 18, 2022