A PHASE 3, RANDOMIZED, OPEN-LABEL, MULTICENTER TRIAL OF ARV-471 (PF-07850327) VS FULVESTRANT IN PARTICIPANTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR ENDOCRINE BASED TREATMENT FOR ADVANCED DISEASE (VERITAC-2)
A PHASE 3, RANDOMIZED, OPEN-LABEL, MULTICENTER TRIAL OF ARV-471 (PF-07850327) VS FULVESTRANT IN PARTICIPANTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR ENDOCRINE BASED TREATMENT FOR ADVANCED DISEASE (VERITAC-2)
A study to learn about a new medicine called ARV-471 (PF-07850327) in people who have advanced metastatic breast cancer.
The purpose of this study is to learn about the safety and effects of the study medicine ARV-471 (PF-07850327, vepdegestrant) compared to fulvestrant (FUL) in participants with advanced breast cancer. Advanced breast cancer is difficult to cure or control with treatment. The cancer may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body, i.e. bones, lungs, brain, or liver. FUL is a medicine already used for treatment of breast cancer while ARV-471 is a new medicine.
This study is seeking participants with breast cancer who:
Half of the participants will be given ARV-471 while the other half of the participants will be given FUL.
Participants who get ARV-471 will take ARV-471 by mouth with food, one time a day. During the first treatment cycle participants who will get FUL will be given FUL by shots into the muscles on Day 1 and again 2 weeks later. After the first month, FUL shots will be given on the first day of each new treatment cycle. One treatment cycle is 28 days.
Participants will receive the study medicine until their breast cancer worsens or side effects become too severe. Participants will have visits at the study clinic about every 4 weeks.
Inclusion Criteria:
Exclusion Criteria:
Encinitas, California 92024, United States
N. Venice, Florida 34275, United States
CABA, Buenos Aires 1417, Argentina
Ciudad Autónoma de Buenos Aires, Buenos Aires C1023AAB, Argentina
CABA, Buenos Aires F.D. 1125, Argentina
Buenos Aires, 1431, Argentina
Porto Alegre, Rio Grande do Sul 90110-270, Brazil
Fuzhou Fujian, Fujian 350001, China
Luoyang, Henan 471003, China
Wuhan, Hubei 430022, China
Wuhan, Hubei 430040, China
Nanjing, Jiangsu 210031, China
Shanghai, Shanghai Municipality 200025, China
Hangzhou, Zhejiang 310052, China
Clermont-Ferrand, Puy-de-dôme 63011, France
Chaidari/Athens, Attikí 12462, Greece
New Delhi, National Capital Territory of Delhi 110085, India
Kolkata, West Bengal 700020, India
Bologna, Emilia-Romagna 40138, Italy
Rome, Lazio 00168, Italy
Ina-machi, Saitama 362-0806, Japan
Bunkyo-ku, Tokyo 113-8431, Japan
Bunkyo-ku, Tokyo 113-8677, Japan
Koto-ku, Tokyo 135-8550, Japan
Koto, Tokyo 135-8550, Japan
Shinjuku-ku, Tokyo 162-8655, Japan
Guadajalara, Jalisco 44600, Mexico
Krakow, Lesser Poland Voivodeship 30-348, Poland
Warsaw, Masovian Voivodeship 02-781, Poland
Lodz, Łódź Voivodeship 90-338, Poland
Hato Rey, Puerto RICO 00917, Puerto Rico
Namdong-gu, Incheon-gwangyeoksi [incheon] 21565, South Korea
Seoul, Seoul-teukbyeolsi [seoul] 03722, South Korea
Seoul, Seoul-teukbyeolsi [seoul] 06273, South Korea
Seoul, Seoul-teukbyeolsi [seoul] 06591, South Korea
L'Hospitalet de Llobregat, Catalunya [cataluña] 08908, Spain
Kaohsiung Niao Sung Dist, Kaohsiung 83301, Taiwan
Altindağ, Ankara 06230, Turkey (Türkiye)
Istanbul, İ̇stanbul 34722, Turkey (Türkiye)