Not currently recruiting at University of California Health

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 study on Breast Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSF
Dates
study started
completion around

Description

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.

Official Title

AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 3 STUDY OF PF-07220060 PLUS FULVESTRANT COMPARED TO INVESTIGATOR'S CHOICE OF THERAPY IN PARTICIPANTS OVER 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

Keywords

Advanced or Metastatic Breast Cancer, Estrogen receptor positive [ER(+)], Human epidermal growth factor receptor 2 negative [HER(-)], ER(+)/HER2(-), Advanced Breast Cancer, Breast tumor, Breast cancer, fulvestrant, everolimus, exemestane, Partial Response+ (PR+), Metastatic breast cancer, Hormone Therapy, Hormone positive breast cancer, Recurrent breast cancer, HR+, HER2-negative, Relapse, Recurrent, Second line treatment., Breast Neoplasms, PF-07220060 CDK4 inhibitor

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
  • Documented estrogen receptor (ER) and/or progesterone receptor (PR)- positive tumor
  • Documented HER2-negative tumor
  • Able to provide a sufficient amount of representative formalin fixed, paraffin embedded (FFPE) tumor tissue specimen.
  • Must have received CDK4/6i plus NSAI defined per study protocol. There must be documented PD during or after CDK4/6i treatment.
  • Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤2.

You CAN'T join if...

  • Any medical or psychiatric condition that may increase the risk of study participation or make the participant inappropriate for the study.
  • In visceral crisis at risk of immediately life-threatening complications in the short term.
  • Known active uncontrolled or symptomatic central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
  • Prior treatment with any of the following:
  • Everolimus or investigational anti-cancer agents in any setting
  • Prior chemotherapy in the advanced setting
  • Radiation within 2 weeks of randomization
  • Current use or anticipated need for any prohibited food, supplements or concomitant medication(s) (ie, other anti-cancer therapies, other endocrine therapies, growth factors, chronic systemic corticosteroids, strong cytochrome P450 3A4/5 [CYP3A4/5] or uridine 5' diphosphate-glucuronosyltransferase 2B7 [UGT2B7] inhibitors and inducers, direct oral anticoagulants, proton pump inhibitors).
  • Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.

Locations

  • UCSF - John Muir Health Cancer Center Berkeley not yet accepting patients
    Berkeley California 94702 United States
  • Zuckerberg San Francisco General Hospital and Trauma Center not yet accepting patients
    San Francisco California 94110 United States
  • UCSF Medical Center at Mission Bay not yet accepting patients
    San Francisco California 94158 United States
  • UCSF Cancer Center San Mateo not yet accepting patients
    San Mateo California 94402 United States
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center not yet accepting patients
    Torrance California 90502 United States
  • Harbor UCLA not yet accepting patients
    Torrance California 90509 United States
  • Hoag Memorial Hospital Presbyterian not yet accepting patients
    Newport Beach California 92663 United States
  • Hoag Health Center Irvine not yet accepting patients
    Irvine California 92618 United States
  • Hoag Hospital Irvine not yet accepting patients
    Irvine California 92618 United States
  • Keck Hospital of USC accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT06105632
Phase
Phase 3 Breast Cancer Research Study
Study Type
Interventional
Participants
Expecting 500 study participants
Last Updated