RightFit
RecruitingPhase 3

A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.

An Interventional, Open-Label, Randomized, Multicenter, Phase 3 Study of PF-07248144 Plus Fulvestrant Compared to Investigator's Choice of Therapy in Adult Participants With Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer Whose Disease Progressed After Prior CDK4/6 Inhibitor-based Therapy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Pills, Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "PF-07248144 is a tablet that will be taken by mouth at home every day in a 28-day cycle."
  • "Fulvestrant will be given as two injections (one injection in the buttock) at visits to the study clinic."
  • "Everolimus and exemestane are also tablets and will be taken by mouth at home every day in a 28-day cycle."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety and effects of PF-07248144 plus fulvestrant compared with everolimus plus hormone therapy. It is for people whose advanced or spreading breast cancer got worse after treatment with a CDK4/6 inhibitor, a drug that blocks cancer growth. The cancer must be HR-positive (hormones help it grow) and HER2-negative (it has little or no HER2 protein).

The purpose of this study is to learn about the safety and effects of the study medicine PF-07248144 when given along with fulvestrant for the possible treatment of HR-positive, HER2-negative advanced or metastatic breast cancer. HR-positive breast cancer cells have proteins on their surface called receptors that bind to hormones like estrogen and progesterone (female sex hormones). These hormones can promote the growth of cancer cells. HER2-negative describes cells that have a small amount or none of a protein called HER2 on their surface. In normal cells, HER2 helps control cell growth. Cancer cells that are HER2-negative may grow more slowly and are less likely to recur (come back) or spread to other parts of the body than cancer cells that have a large amount of HER2 on their surface. Advanced cancer is a term that is often used to describe cancer that is unlikely to be cured. Metastatic cancer is the type where the cancer cells spread from one part of the body to another. This study is seeking for participants whose breast cancer has gotten worsen after receiving cyclin dependent kinase (CDK) 4/6 inhibitor-based therapy. Half of participants in this study will receive their usual study treatment, everolimus with endocrine therapy (either exemestane or fulvestrant) for HR-positive/HER2-negative advanced or metastatic breast cancer (A/mBC). The study doctor will discuss which hormone therapy is right for the participant before treatment begins. PF-07248144 is a tablet that will be taken by mouth at home every day in a 28-day cycle. Fulvestrant will be given as two injections (one injection in the buttock) at visits to the study clinic. Everolimus and exemestane are also tablets and will be taken by mouth at home every day in a 28-day cycle. The study will compare the experiences of people receiving PF-07248144 in combination with fulvestrant to those of the people who do not. This will help see if PF-07248144 in combination with fulvestrant is safe and effective.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have HR-positive, HER2-negative breast cancer that has grown nearby or spread and cannot be cured with surgery or radiation.
  • Have had a CDK4/6 inhibitor with hormone therapy for advanced or spreading cancer, or after surgery. The cancer must have gotten worse during treatment or within 12 months after the last CDK4/6 inhibitor dose.
  • Past CDK4/6 inhibitor or hormone treatment alone, or another course of them together for advanced or spreading cancer, is allowed. Past treatment targeting the ESR1 or BRCA1/2 genes is also allowed.
  • Have cancer that can be measured on scans, or cancer only in the bones that cannot be measured.
  • Be fully active, or able to walk and do light work but not hard physical activity.

Who can't join

  • Tests of tumor tissue show changes in the PIK3CA, AKT1, or PTEN genes.
  • Have had more than two rounds of different whole-body treatments for advanced or spreading cancer.
  • Have had chemotherapy for advanced or spreading cancer, including drugs that use antibodies to deliver cancer-killing medicine. Chemotherapy before or after surgery does not rule you out.
  • Have a medical or mental health condition that could make the study unsafe or unsuitable for you.
  • Have kidney problems, liver problems, or abnormal blood test results involving blood cells.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Confirmed diagnosis of HR-positive HER2-negative breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent. * Prior CDK4/6 inhibitor therapy in combination with endocrine therapy in advance metastatic setting or in adjuvant setting with documented progression during or within 12 months after the last dose of CDK4/6i. * Participants are eligible if they previously received CDK4/6i or ET as a monotherapy, or in combination for rechallenge therapy in the advance or metastatic setting; have received prior therapy targeting estrogen receptor 1 (ESR1) or breast cancer gene (BRCA)1/2. * Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1. Exclusion Criteria: * Documented detectable PIK3CA/AKT1/PTEN alterations in tissue * Received greater than two prior lines of systemic therapy in the advance or metastatic setting * Had received any prior chemotherapy, including antibody drug conjugates (ADCs), in advance or metastatic setting. Participants who have previously received chemotherapy in the (neo)adjuvant setting are not excluded from the study. * Any medical or psychiatric condition that may increase the risk of study participation or make the participant inappropriate for the study. * Renal impairment, hepatic dysfunction, or hematologic abnormalities.

Study sites (215)

AK

AR

AZ

CA

CO

CT

DC

GA

IL

KY

LA

MA

MD

MI

MN

MO

MT

NC

NJ

NV

NY

SC

TN

TX

UT

VA

WA

WI