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NCT06105632 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Advanced or Metastatic Breast Cancer, sponsored by Pfizer.
- Active
- Registry status
- Phase 2
- Development phase
- 333
- Enrollment target
- 20
- Study locations
NCT06105632: Active Phase 2 study of Advanced or Metastatic Breast Cancer, sponsored by Pfizer.
NCT06105632 is a Phase 2 study of Advanced or Metastatic Breast Cancer that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 333 participants, roughly in line with the 313-participant average among 3 other Advanced or Metastatic Breast Cancer trials with a reported enrollment target. The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06105632, a Phase 2 study of Advanced or Metastatic Breast Cancer, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 333 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Exemestane
- DRUG Everolimus
- DRUG Fulvestrant
- DRUG PF-07220060 CDK4 inhibitor
Study Locations (20)
California
- Hoag Health Center Irvine - Irvine
- Hoag Hospital Irvine - Irvine
- Keck Hospital of USC - Los Angeles
- Los Angeles General Medical Center - Los Angeles
- USC/Norris Comprehensive Cancer Center - Los Angeles
- Hoag Memorial Hospital Presbyterian - Newport Beach
- Keck Medical Center of USC Pasadena - Pasadena
Buenos Aires F.D.
- Centro de Investigaciones Medicas y Desarrollo LC - Buenos Aires
- CIPREC - Buenos Aires
- Organizacion Medica de Investigacion - CABA
Connecticut
- Danbury Hospital - Danbury
- Norwalk Hospital - Norwalk
District of Columbia
- Georgetown University Medical Center - Washington D.C.
- MedStar Washington Hospital Center - Washington D.C.
Montana
- Intermountain Health St. Vincent Regional Hospital - Billings
- Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana - Billings
Texas
- Memorial Hermann Cancer Center - Houston
- Baylor Scott & White Medical Center - Round Rock - Round Rock
Nevada
- Cancer Care Specialists - Reno
New York
- Vassar Brothers Medical Center - Poughkeepsie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 333 participants |
| Start Date | 2024-01-09 |
| Est. Completion | 2028-01-21 |
| Phase | Phase 2 |
What the registry record for NCT06105632 still lists
NCT06105632 is an interventional study that assigns participants to a tested intervention. The registered 333 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 313-participant average among 3 other Advanced or Metastatic Breast Cancer trials with a reported enrollment target.
The record links to 1 condition, with Advanced or Metastatic Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Exemestane is the first listed.
NCT06105632 names 20 study sites across 8 states, led by California, Buenos Aires F.D., Connecticut.
Frequently Asked Questions
What is clinical trial NCT06105632 about?
NCT06105632 is a clinical study titled "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". 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 ...
What is the current status of trial NCT06105632?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 333 participants. The study started on 2024-01-09. Estimated completion is 2028-01-21.
What conditions does trial NCT06105632 study?
This clinical trial studies the following conditions: Advanced or Metastatic Breast Cancer.
What interventions are being tested in trial NCT06105632?
The interventions under investigation include: Exemestane (DRUG), Everolimus (DRUG), Fulvestrant (DRUG), PF-07220060 CDK4 inhibitor (DRUG).
Who is sponsoring clinical trial NCT06105632?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06105632 being conducted?
This trial has 20 study locations across California, Connecticut, District of Columbia, Montana, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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