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AMEERA-5: Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer

Sponsor
Sanofi (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04478266
Collaborator
(none)
1,068
Enrollment
300
Locations
2
Arms
80
Anticipated Duration (Months)
3.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary Objective:

To determine whether Amcenestrant (SAR439859) in combination with palbociclib improvesprogression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with ER+, HER2- advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease.

Secondary Objective:

  • To compare the overall survival in both treatment arms

  • To evaluate the objective response rate in both treatment arms

  • To evaluate the duration of response in both treatment arms

  • To evaluate the clinical benefit rate in both treatment arms

  • To evaluate progression-free survival on next line of therapy

  • To evaluate the pharmacokinetics of amcenestrant, and palbociclib

  • To evaluate health-related quality of life in both treatment arms

  • To evaluate the time to first chemotherapy in both treatment arms

  • To evaluate safety in both treatment arms

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Study duration per participant is approximately 59 months, which includes a 33- month treatment period

Study Design

Study Type:
Interventional
Actual Enrollment :
1068 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Multicenter, Double-blind Phase 3 Study of Amcenestrant (SAR439859) Plus Palbociclib Versus Letrozole Plus Palbociclib for the Treatment of Patients With ER (+), HER2 (-) Breast Cancer Who Have Not Received Prior Systemic Anti-cancer Treatment for Advanced Disease
Actual Study Start Date :
Oct 14, 2020
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jun 15, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Amcenestrant with Letrozole-matching placebo Arm

Participants in Amcenestrant with Letrozole-matching placebo Arm will be administered: Amcenestrant dose, once daily, continuously. Letrozole-matching placebo, once daily, continuously. Palbociclib dose once daily, days 1-21 of every 28-day cycle. Goserelin once every 4 weeks in pre/peri menopausal women and men

Drug: SAR439859
Pharmaceutical form: Tablets Route of Administration: Oral
Other Names:
  • Amcenestrant

    • Drug: Palbociclib
    Pharmaceutical form: Capsules/Tablets Route of Administration: Oral
    Other Names:
  • Ibrance

    • Drug: Goserelin
    Pharmaceutical form: Depot Injection Route of Administration: Subcutaneous

    Drug: Letrozole-matching placebo
    Pharmaceutical form: Tablets Route of Administration: Orally
    Active Comparator: Letrozole with Amcenestrant matching placebo Arm

    Participants in Letrozole with Amcenestrant-matching placebo Arm will be administered: Letrozole dose, once daily, continuously. Amcenestrant-matching placebo, once daily, continuously. Palbociclib dose once daily, days 1-21 of every 28-day cycle Goserelin once every 4 weeks in pre/peri menopausal women and men

    Drug: Amcenestrant-matching placebo
    Pharmaceutical form: Tablets Route of Administration: Oral

    Drug: Palbociclib
    Pharmaceutical form: Capsules/Tablets Route of Administration: Oral
    Other Names:
  • Ibrance

    • Drug: Letrozole
    Pharmaceutical form: Tablets Route of Administration: Orally

    Drug: Goserelin
    Pharmaceutical form: Depot Injection Route of Administration: Subcutaneous

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival [From randomization date to date of first documentation of progression OR death (up to approximately 4 years)]

      Progression-free survival is defined as the time interval from the date of randomization to the date of first documented tumor progression as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or death (due to any cause), whichever come first.

    Secondary Outcome Measures

    1. Overall Survival [From randomization date to date of death (up to approximately 6 years)]

      Overall survival is defined as the time interval from the date of randomization to the date of documented death (due to any cause).

    2. Objective Response Rate [From randomization date to end of treatment (up to approximately 4 years)]

      Objective response rate is defined as the proportion of participants who have a CR or PR, as best overall response determined as per RECIST 1.1, from the date of randomization to the date of until disease progression, death, cutoff date, initiation of post-treatment anti-cancer therapy, whichever occurs first.

    3. Duration of Response [From randomization date to end of treatment (up to approximately 4 years)]

      Duration of response is defined as the time from first documented evidence of CR or PR until progressive disease (PD) as determined as per RECIST 1.1 or death from any cause, whichever occurs first.

    4. Clinical Benefit Rate [From randomization date to end of treatment (up to approximately 4 years)]

      Clinical benefit rate is defined as the proportion of participants who have a confirmed CR, PR, or SD for at least 24 weeks determined as per RECIST 1.1, from the date of randomization until disease progression, death, cutoff date, initiation of post-treatment anti-cancer therapy, whichever occurs first

    5. PK parameter: Plasma concentrations [From randomization date to end of treatment (up to approximately 4 years)]

      Plasma concentrations of Amcenestrant and palbociclib.

    6. Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) [From Baseline up to end of study (approximately 6.5 years)]

      Incidence of participants with TEAEs, SAEs and laboratory abnormalities according to NCI CTCAE V5

    7. Time to First Chemotherapy [From randomization date to end of treatment (up to approximately 4 years)]

      Time to chemotherapy is defined as the time interval from the date of randomization to the start date of the first chemotherapy after study treatment discontinuation.

    8. Health state utility and health status will be assessed using the European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L) [From Baseline to 90 days after end of treatment (up to approximately 4 years)]

      Change From Baseline between treatment comparison Using the European Quality of Life- 5-Dimension 5 Level (EQ-5D 5L).

    9. Disease-specific HRQL will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30) [From Baseline to 90 days after end of treatment (up to approximately 4 years)]

      Change From Baseline between treatment comparison in Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).

    10. Disease- and treatment-related quality of life will be assessed using the EORTC breast cancer module (QLQ-BR45) questionnaire [From Baseline to 90 days after end of treatment (up to approximately 4 years)]

      Change From Baseline between treatment comparison in Quality of Life Using the EORTC QLQ-BR45 (Breast) Questionnaire.

    11. Disease- and treatment-related quality of life will be assessed using the EORTC breast cancer module (QLQ-BR23) questionnaire [From Baseline to 90 days after end of treatment (up to approximately 4 years)]

      Change From Baseline between treatment comparison in Quality of Life Using the EORTC QLQ-BR23 (Breast) Questionnaire.

    12. Progression-free survival on next line of therapy (PFS2) [From randomization date to date of death (up to approximately 6.5 years)]

      PFS2 is defined as the time from the date of randomization to the date of first documentation of PD on the next systemic anti-cancer therapy according to investigator or death due to any cause, whichever occurs first.

    Eligibility Criteria

    Criteria

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

    • Adult participants with loco-regional recurrent or metastatic disease not amenable to curative treatment

    • Confirmed diagnosis of ER+/HER2- breast cancer

    • No prior systemic treatment for loco-regional recurrent or metastatic disease

    • Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease

    • Eastern Cooperative Oncology Group (ECOG) performance status 0-2

    • Participants should be willing to provide tumor tissue

    • Capable of giving informed consent

    Exclusion criteria:

    • Known active brain metastases

    • Prior neo (adjuvant) treatment with any selective estrogen receptor degrader (SERD)

    • Inadequate organ and marrow function

    • Disease recurrence while on, or within 12 months of completion of (neo)adjuvant endocrine therapy

    • Pregnant, breastfeeding, or woman of child bearing potential unwilling to use recommended contraception methods

    • Male participants who disagree to follow contraception

    • Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term

    • Participants with significant concomitant illness

    The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational Site Number :8400075 Daphne Alabama United States 36526
    2 Investigational Site Number :8400083 Glendale Arizona United States 85308
    3 Investigational Site Number :8400066 Tucson Arizona United States 85712
    4 Investigational Site Number :8400038 Fullerton California United States 92835
    5 Investigational Site Number :8400056 Los Alamitos California United States 90720
    6 Investigational Site Number :8400040 San Francisco California United States 94158
    7 Investigational Site Number :8400029 Santa Monica California United States 90404
    8 Investigational Site Number :8400036 Sylmar California United States 91342
    9 Investigational Site Number :8400032 Torrance California United States 90502
    10 Investigational Site Number :8400052 Whittier California United States 90602
    11 Investigational Site Number :8400051 Colorado Springs Colorado United States 80909
    12 Investigational Site Number :8400025 Denver Colorado United States 80262
    13 Investigational Site Number :8400050 Fort Collins Colorado United States 80528
    14 Investigational Site Number :8400021 Fort Lauderdale Florida United States 33309
    15 Investigational Site Number :8400059 Lakeland Florida United States 33805
    16 Investigational Site Number :8400053 Orlando Florida United States 32804
    17 Investigational Site Number :8400048 Orlando Florida United States 32806
    18 Investigational Site Number :8400081 Palm Bay Florida United States 32901
    19 Investigational Site Number :8400055 Athens Georgia United States 30607
    20 Investigational Site Number :8400016 Atlanta Georgia United States 30342
    21 Investigational Site Number :8400034 Savannah Georgia United States 31405
    22 Investigational Site Number :8400035 Thomasville Georgia United States 31792
    23 Investigational Site Number :8400087 Arlington Heights Illinois United States 60005
    24 Investigational Site Number :8400079 Chicago Ridge Illinois United States 60415
    25 Investigational Site Number :8400039 Chicago Illinois United States 60612
    26 Investigational Site Number :8400062 Peoria Illinois United States 61615
    27 Investigational Site Number :8400008 Fort Wayne Indiana United States 46804
    28 Investigational Site Number :8400006 Iowa City Iowa United States 52242
    29 Investigational Site Number :8400013 Westwood Kansas United States 66205-2003
    30 Investigational Site Number :8400028 Scarborough Maine United States 04074-9308
    31 Investigational Site Number :8400017 Boston Massachusetts United States 02114
    32 Investigational Site Number :8400076 Danvers Massachusetts United States 01923
    33 Investigational Site Number :8400077 Newton Massachusetts United States 02463
    34 Investigational Site Number :8400002 Ann Arbor Michigan United States 48109
    35 Investigational Site Number :8400005 Kansas City Missouri United States 64111
    36 Investigational Site Number :8400004 Saint Louis Missouri United States 63141
    37 Investigational Site Number :8400037 Henderson Nevada United States 89074
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    40 Investigational Site Number :8400015 New Brunswick New Jersey United States 08901-1914
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    42 Investigational Site Number :8400057 Mineola New York United States 11501
    43 Investigational Site Number :8400010 New York New York United States 10016
    44 Investigational Site Number :8400023 Stony Brook New York United States 11794-8121
    45 Investigational Site Number :8400009 Winston-Salem North Carolina United States 27157
    46 Investigational Site Number :8400060 Tulsa Oklahoma United States 74146
    47 Investigational Site Number :8400067 Tigard Oregon United States 97223
    48 Investigational Site Number :8400089 Philadelphia Pennsylvania United States 19104
    49 Investigational Site Number :8400001 Pittsburgh Pennsylvania United States 15232
    50 Investigational Site Number :8400073 Austin Texas United States 78745
    51 Investigational Site Number :8400071 Dallas Texas United States 75203
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    54 Investigational Site Number :8400080 Denton Texas United States 76021
    55 Investigational Site Number :8400074 El Paso Texas United States 79902
    56 Investigational Site Number :8400061 Houston Texas United States 77024
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    60 Investigational Site Number :8400086 The Woodlands Texas United States 77380
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    62 Investigational Site Number :8400082 Webster Texas United States 77598
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    66 Investigational Site Number :8400069 Winchester Virginia United States 22601
    67 Investigational Site Number :8400088 Madison Wisconsin United States 53717
    68 Investigational Site Number :0320001 Caba Buenos Aires Argentina C1012AAR
    69 Investigational Site Number :0320005 Caba Buenos Aires Argentina C1019ABS
    70 Investigational Site Number :0320008 Capital Federal Buenos Aires Argentina C1417DTB
    71 Investigational Site Number :0320006 Pergamino Buenos Aires Argentina B2700CPM
    72 Investigational Site Number :0320010 Cordoba Córdoba Argentina 5000
    73 Investigational Site Number :0320002 Rosario Santa Fe Argentina 2000
    74 Investigational Site Number :0320004 Buenos Aires Argentina C1125ABD
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    76 Investigational Site Number :0320009 Mar del Plata Argentina B7600FYK
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    78 Investigational Site Number :0360004 Macquarie Park New South Wales Australia 2109
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    80 Investigational Site Number :0360003 Wahroonga New South Wales Australia 2076
    81 Investigational Site Number :0360002 Richmond Victoria Australia 3121
    82 Investigational Site Number :0360001 Nedlands Western Australia Australia 6009
    83 Investigational Site Number :0400001 Graz Austria 8036
    84 Investigational Site Number :0560003 Bruxelles Belgium BE-1200
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    86 Investigational Site Number :0560001 Leuven Belgium 3000
    87 Investigational Site Number :0560002 Namur Belgium 5000
    88 Investigational Site Number :0760005 Porto Alegre Rio Grande Do Sul Brazil 90035 003
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    106 Investigational Site Number :1520005 La Serena Coquimbo Chile 1720430
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    133 Investigational Site Number :1560011 Harbin China 150081
    134 Investigational Site Number :1560020 Hefei China 230001
    135 Investigational Site Number :1560041 Hefei China 233004
    136 Investigational Site Number :1560018 Jinan China 250013
    137 Investigational Site Number :1560046 Jinan China 250117
    138 Investigational Site Number :1560051 Jining China
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    140 Investigational Site Number :1560055 Luoyang China 471003
    141 Investigational Site Number :1560048 Neijiang China 641003
    142 Investigational Site Number :1560001 Shanghai China 200032
    143 Investigational Site Number :1560037 Shaoguan China 512025
    144 Investigational Site Number :1560050 Suining China 629000
    145 Investigational Site Number :1560016 Suzhou China 215004
    146 Investigational Site Number :1560028 Tianjin China 300060
    147 Investigational Site Number :1560052 Urumqi Xinjiang China 830000
    148 Investigational Site Number :1560033 Wuhan China 430060
    149 Investigational Site Number :1560024 Wuhan China 430079
    150 Investigational Site Number :1560045 Xi'an China 710004
    151 Investigational Site Number :1560044 Xi'An China 710061
    152 Investigational Site Number :1560027 Xuzhou China 221009
    153 Investigational Site Number :1560049 Yantai China 264000
    154 Investigational Site Number :1560022 Zhengzhou China 450008
    155 Investigational Site Number :2030001 Brno Czechia 65653
    156 Investigational Site Number :2030003 Pardubice Czechia 53002
    157 Investigational Site Number :2030002 Praha 2 Czechia 12808
    158 Investigational Site Number :2330001 Tallinn Estonia 13419
    159 Investigational Site Number :2330002 Tartu Estonia 50406
    160 Investigational Site Number :2460001 Helsinki Finland 00029
    161 Investigational Site Number :2460002 Tampere Finland 33520
    162 Investigational Site Number :2460003 Turku Finland FIN-20520
    163 Investigational Site Number :2500009 Nice France 06189
    164 Investigational Site Number :2500003 Paris France 75010
    165 Investigational Site Number :2500001 Paris France 75248
    166 Investigational Site Number :2500006 Poitiers France 86021
    167 Investigational Site Number :2500007 Saint Cloud France 92210
    168 Investigational Site Number :2500002 Saint-Herblain France 44805
    169 Investigational Site Number :2500010 Strasbourg France 67033
    170 Investigational Site Number :2500005 TOULOUSE Cedex 9 France 31059
    171 Investigational Site Number :2500004 Villejuif France 94800
    172 Investigational Site Number :2680005 Batumi Georgia 6000
    173 Investigational Site Number :2680006 Kutaisi Georgia 4600
    174 Investigational Site Number :2680001 Tbilisi Georgia 0112
    175 Investigational Site Number :2680002 Tbilisi Georgia 0144
    176 Investigational Site Number :2680004 Tbilisi Georgia 0159
    177 Investigational Site Number :2680007 Tbilisi Georgia 0159
    178 Investigational Site Number :2680003 Tbilisi Georgia 0168
    179 Investigational Site Number :2760006 Bottrop Germany 46236
    180 Investigational Site Number :2760003 Münster Germany 48149
    181 Investigational Site Number :2760007 Oldenburg in Holstein Germany 23758
    182 Investigational Site Number :2760001 Ulm Germany 89075
    183 Investigational Site Number :3480004 Budapest Hungary 1032
    184 Investigational Site Number :3480008 Budapest Hungary 1115
    185 Investigational Site Number :3480002 Debrecen Hungary 4032
    186 Investigational Site Number :3480011 Gyula Hungary 5700
    187 Investigational Site Number :3480005 Győr Hungary 9023
    188 Investigational Site Number :3480003 Kaposvár Hungary 7400
    189 Investigational Site Number :3480009 Kecskemét Hungary 6000
    190 Investigational Site Number :3480010 Miskolc Hungary 3526
    191 Investigational Site Number :3480001 Nyíregyháza Hungary 4400
    192 Investigational Site Number :3800008 Meldola (FC) Emilia-Romagna Italy 47014
    193 Investigational Site Number :3800003 Rozzano Milano Italy 20089
    194 Investigational Site Number :3800007 Monza Monza E Brianza Italy 20052
    195 Investigational Site Number :3800009 Aviano Pordenone Italy 33081
    196 Investigational Site Number :3800010 Bologna Italy 40138
    197 Investigational Site Number :3800001 Genova Italy 16132
    198 Investigational Site Number :3800004 Milano Italy 20132
    199 Investigational Site Number :3800002 Milano Italy 20141
    200 Investigational Site Number :3800006 Napoli Italy 80131
    201 Investigational Site Number :3800005 Prato Italy 59100
    202 Investigational Site Number :3920016 Nagoya-shi Aichi Japan 460-0001
    203 Investigational Site Number :3920007 Nagoya-shi Aichi Japan 464-8681
    204 Investigational Site Number :3920002 Kashiwa-shi Chiba Japan 277-8577
    205 Investigational Site Number :3920009 Matsuyama-shi Ehime Japan 791-0280
    206 Investigational Site Number :3920019 Kurume-shi Fukuoka Japan 830-0013
    207 Investigational Site Number :3920017 Takasaki-shi Gunma Japan 370-0829
    208 Investigational Site Number :3920010 Hiroshima-shi Hiroshima Japan 730-8518
    209 Investigational Site Number :3920001 Sapporo-shi Hokkaido Japan 003-0804
    210 Investigational Site Number :3920012 Kagoshima-shi Kagoshima Japan 892-0833
    211 Investigational Site Number :3920014 Yokohama-shi Kanagawa Japan 222-0036
    212 Investigational Site Number :3920006 Yokohama-shi Kanagawa Japan 241-8515
    213 Investigational Site Number :3920020 Sendai-shi Miyagi Japan 980-0803
    214 Investigational Site Number :3920022 Miyazaki-shi Miyazaki Japan 880-8510
    215 Investigational Site Number :3920008 Osaka-shi Osaka Japan 540-0006
    216 Investigational Site Number :3920018 Osaka-shi Osaka Japan 553-0003
    217 Investigational Site Number :3920013 Hidaka-shi Saitama Japan 350-1241
    218 Investigational Site Number :3920021 Shizuoka-shi Shizuoka Japan 420-8527
    219 Investigational Site Number :3920003 Koto-ku Tokyo Japan 135-8550
    220 Investigational Site Number :3920015 Meguro-ku Tokyo Japan 152-8902
    221 Investigational Site Number :3920005 Shinagawa-ku Tokyo Japan 142-8666
    222 Investigational Site Number :4100006 Goyang-si Gyeonggi-do Korea, Republic of 10408
    223 Investigational Site Number :4100005 Seongnam Gyeonggi-do Korea, Republic of 463-707
    224 Investigational Site Number :4100007 Seoul Seoul-teukbyeolsi Korea, Republic of 02841
    225 Investigational Site Number :4100004 Seoul Seoul-teukbyeolsi Korea, Republic of 03722
    226 Investigational Site Number :4100003 Seoul Seoul-teukbyeolsi Korea, Republic of 110-744
    227 Investigational Site Number :4100002 Seoul Seoul-teukbyeolsi Korea, Republic of 135-710
    228 Investigational Site Number :4100001 Seoul Seoul-teukbyeolsi Korea, Republic of 138-878
    229 Investigational Site Number :4100009 Seochogu Korea, Republic of 6591
    230 Investigational Site Number :4100008 Seongnam-si, Gyeonggi-do Korea, Republic of 13496
    231 Investigational Site Number :5280006 Arnhem Netherlands 6815 AD
    232 Investigational Site Number :5280007 Breda Netherlands 4818 CK
    233 Investigational Site Number :5280005 Delft Netherlands 2625 AD
    234 Investigational Site Number :5280003 Hoofddorp Netherlands 2134 TM
    235 Investigational Site Number :5280001 Maastricht Netherlands 6229 HX
    236 Investigational Site Number :6160002 Tomaszow Mazowiecki Lódzkie Poland 97-200
    237 Investigational Site Number :6160001 Warszawa Mazowieckie Poland 02-781
    238 Investigational Site Number :6160004 Gdynia Pomorskie Poland 81-519
    239 Investigational Site Number :6160003 Poznan Wielkopolskie Poland 61-485
    240 Investigational Site Number :6160007 Poznan Wielkopolskie Poland 61-866
    241 Investigational Site Number :6160006 Szczecin Zachodniopomorskie Poland 71-730
    242 Investigational Site Number :6200005 Almada Portugal 2801-951
    243 Investigational Site Number :6200001 Lisboa Portugal 1649-035
    244 Investigational Site Number :6200004 Porto Portugal 4099-001
    245 Investigational Site Number :6200002 Porto Portugal 4200-319
    246 Investigational Site Number :8400003 Hato Rey Puerto Rico 00917
    247 Investigational Site Number :6430007 Arkhangelsk Russian Federation 163045
    248 Investigational Site Number :6430004 Krasnogorskiy District Russian Federation 143423
    249 Investigational Site Number :6430009 Moscow Region Russian Federation 143442
    250 Investigational Site Number :6430008 Moscow Russian Federation 115478
    251 Investigational Site Number :6430003 Moscow Russian Federation 117186
    252 Investigational Site Number :6430005 Moscow Russian Federation 117997
    253 Investigational Site Number :6430006 Moscow Russian Federation 129090
    254 Investigational Site Number :6430001 Saint -Petersburg Russian Federation 197758
    255 Investigational Site Number :6430010 Saint Petersburg Russian Federation 199034
    256 Investigational Site Number :7020002 Singapore Singapore 119228
    257 Investigational Site Number :7020004 Singapore Singapore 169610
    258 Investigational Site Number :7020003 Singapore Singapore 308433
    259 Investigational Site Number :7020001 Singapore Singapore 329563
    260 Investigational Site Number :7100004 Cape Town South Africa 7570
    261 Investigational Site Number :7100006 Johannesburg South Africa 1709
    262 Investigational Site Number :7100002 Johannesburg South Africa 2196
    263 Investigational Site Number :7240011 Barcelona Barcelona [Barcelona] Spain 08017
    264 Investigational Site Number :7240008 Barcelona / Sabadell Castilla Y León Spain 08208
    265 Investigational Site Number :7240003 Santiago de Compostela Galicia [Galicia] Spain 15706
    266 Investigational Site Number :7240006 Madrid / Madrid Madrid, Comunidad De Spain 28007
    267 Investigational Site Number :7240002 Madrid / Madrid Madrid, Comunidad De Spain 28050
    268 Investigational Site Number :7240004 Madrid Madrid, Comunidad De Spain 28046
    269 Investigational Site Number :7240005 Valencia / Valencia Valenciana, Comunidad Spain 46010
    270 Investigational Site Number :7240001 Madrid Madrid Spain 28041
    271 Investigational Site Number :7240007 Málaga Spain 29010
    272 Investigational Site Number :7240009 Valencia Spain 46015
    273 Investigational Site Number :1580006 Changhua Taiwan 500
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    277 Investigational Site Number :1580003 Taipei Taiwan 10449
    278 Investigational Site Number :1580004 Taoyuan Taiwan 333
    279 Investigational Site Number :7920006 Adana Turkey 01120
    280 Investigational Site Number :7920008 Ankara Turkey 06100
    281 Investigational Site Number :7920009 Ankara Turkey 06200
    282 Investigational Site Number :7920007 Antalya Turkey 07070
    283 Investigational Site Number :7920005 Bornova Turkey 35100
    284 Investigational Site Number :7920013 Diyarbakır Turkey 21100
    285 Investigational Site Number :7920003 Edirne Turkey 22030
    286 Investigational Site Number :7920001 Istanbul Turkey 34214
    287 Investigational Site Number :7920011 Istanbul Turkey 34457
    288 Investigational Site Number :7920004 Istanbul Turkey 34722
    289 Investigational Site Number :7920012 İzmir Turkey 0000
    290 Investigational Site Number :7920010 Kocaeli Turkey 41380
    291 Investigational Site Number :7920002 Malatya Turkey 44280
    292 Investigational Site Number :8040004 Kharkiv Ukraine 61103
    293 Investigational Site Number :8040010 Kharkiv Ukraine 61166
    294 Investigational Site Number :8040001 Kryvyi Rih Ukraine 50048
    295 Investigational Site Number :8040002 Odesa Ukraine 65025
    296 Investigational Site Number :8040007 Vinnytsia Ukraine 21029
    297 Investigational Site Number :8260001 Glasgow Central Bedfordshire United Kingdom G12 0YN
    298 Investigational Site Number :8260002 Edinburgh Edinburgh, City Of United Kingdom EH4 2XU
    299 Investigational Site Number :8260005 Blackburn Lancashire United Kingdom BB2 3HH
    300 Investigational Site Number :8260004 Oxford Oxfordshire United Kingdom OX3 7LE

    Sponsors and Collaborators

    • Sanofi

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT04478266
    Other Study ID Numbers:
    • EFC15935
    • 2020-001824-33
    • U1111-1233-0486
    First Posted:
    Jul 20, 2020
    Last Update Posted:
    May 10, 2022
    Last Verified:
    May 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
    Goserelin

    Study Results

    No Results Posted as of May 10, 2022