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ACTIVE NOT RECRUITING 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

NCT06105632 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 333 participants
Start Date 2024-01-09
Est. Completion 2028-01-21
Phase Phase 2

Sponsor

Pfizer

769 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06105632

The ClinicalTrials.gov registry entry for NCT06105632 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 333 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06105632 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Buenos Aires F.D., Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06105632?

The interventions under investigation include: Exemestane (DRUG), Everolimus (DRUG), Fulvestrant (DRUG), PF-07220060 CDK4 inhibitor (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06105632?

This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial