A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment (NCT06105632)
AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 2 STUDY OF PF-07220060 PLUS FULVESTRANT COMPARED TO INVESTIGATOR'S CHOICE OF THERAPY IN PARTICIPANTS AT LEAST 18 YEARS OF AGE WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR CDK 4/6 INHIBITOR-BASED THERAPY (FOURLIGHT-1)
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to learn about the safety and how effective the study medicine (PF-07220060) plus fulvestrant is compared to the study doctor's choice of treatment in people with advanced or metastatic breast cancer. Advanced cancer is the one that is unlikely to be cured or taken care of with treatment. Metastatic cancer is the one that has spread to other parts of the body. This study is seeking female and male participants who: * are 18 years of age or older; * are hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative; * have advanced or metastatic breast cancer after taking other treatments before this study; * have not taken or need to take medications that are not allowed by the study protocol; * do not have any medical or mental conditions that may increase the risk of study participation. Half of the participants will take PF-07220060 two times daily by mouth along with fulvestrant. Fulvestrant will be given as a shot into the muscle. The other half will take the study doctor's choice of treatment which can either be: * Fulvestrant alone taken as shot into the muscle. * Everolimus along with exemestane taken once daily by mouth. This study will compare the experiences of participants receiving the study medicine plus fulvestrant to those who are receiving the study doctor's choice of treatment. This will help decide if the study medicine is safe and effective. Participants will receive study treatment and/or will be in the study until: * imaging scans (such as an MRI and/or CT) show that their cancer is getting worse. * the study doctor thinks the participant is no longer benefitting from the study medicine. * has side effects that become too severe. A side effect is a reaction (expected or unexpected) to a medicine or treatment you take. * the participant chooses to stop taking part.
Who can join: Review the eligibility criteria below.
Location: Hoag Health Center Irvine — Irvine, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (48 Sites)
Showing the first 25 of 48 sites.
- Hoag Health Center Irvine — Irvine, California
- Hoag Hospital Irvine — Irvine, California
- Keck Hospital of USC — Los Angeles, California
- Los Angeles General Medical Center — Los Angeles, California
- USC/Norris Comprehensive Cancer Center — Los Angeles, California
- Hoag Memorial Hospital Presbyterian — Newport Beach, California
- MedStar Washington Hospital Center — Washington D.C., District of Columbia
- Intermountain Health St. Vincent Regional Hospital — Billings, Montana
- Memorial Hermann Cancer Center — Houston, Texas
- CIPREC — Buenos Aires, Buenos Aires F.D.
- Clinica Viedma S. A — Viedma, Río Negro Province
- Instituto de Oncología de Rosario — Rosario, Santa Fe Province
- Centro Para la Atención Integral del Paciente Oncologico (CAIPO) — San Miguel de Tucumán, Tucumán Province
- Clínica Universitaria Reina Fabiola — Córdoba,
- Icon Cancer Centre Townsville — Rosslea, Queensland
- Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Pernambuco — Recife, Pernambuco
- Liga Norte Riograndense Contra o Câncer — Natal, Rio Grande do Norte
- Hospital São Lucas da PUCRS — Porto Alegre, Rio Grande do Sul
- Royal Victoria Regional Health Centre — Barrie, Ontario
- CIUSSS- saguenay-Lac-Saint-Jean — Chicoutimi, Quebec
- Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology — Wuhan, Hubei
- Hunan Cancer Hospital — Changsha, Hunan
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality
- Sahyadri Super Speciality Hospital — Pune, Maharashtra
- Rajiv Gandhi Cancer Institute And Research Centre — New Delhi, National Capital Territory of Delhi
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.