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
New Breast Cancer Treatment Trial for Patients Progressing After CDK4/6 Inhibitors
Plain English Summary
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. is a Phase 3 clinical trial sponsored by Pfizer studying Breast Cancer. This trial tests a new drug, PF-07248144, combined with fulvestrant, against standard treatment for advanced breast cancer. It is for adults with hormone-receptor-positive, HER2-negative advanced or metastatic breast cancer that has worsened after prior treatment with CDK4/6 inhibitors. Participants will receive either the new drug combination or their doctor's choice of standard therapy, with treatments given by mouth and injection. Alternative treatments include continuing endocrine therapy with or without other drugs, or chemotherapy, depending on the patient's history and doctor's recommendation. The trial aims to enroll 400 participants.
Official Summary
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 ef
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you have HR-positive, HER2-negative advanced or metastatic breast cancer that has progressed after CDK4/6 inhibitor therapy. You cannot join if you have certain genetic alterations (PIK3CA/AKT1/PTEN), have received more than two prior lines of therapy for advanced/metastatic cancer, or have received chemotherapy for advanced/metastatic cancer. Participants must be adults (18 years or older) and have an ECOG performance status of 0 or 1 (meaning they are able to carry out all self-care and are ambulatory for less than half of their waking hours). This trial is studying Breast Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The main goal is to see if the new drug combination delays cancer growth or spread, meaning patients may have more time without their cancer worsening. The specific primary outcome measures are: Progression Free Survival (PFS) as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (From the date of randomization until disease progression or death due to any cause (up to approximately 2 years)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial addresses a critical need for new treatments for patients whose advanced breast cancer has stopped responding to common therapies like CDK4/6 inhibitors. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Breast Cancer, where improved treatment options are needed.
Investor Insight
This trial targets a significant unmet need in a large breast cancer market, with a new drug class (KAT6 inhibitors) offering potential differentiation and a competitive advantage if successful. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.
Is This Trial Right for Me?
Ask your doctor if your cancer has progressed after CDK4/6 inhibitor therapy and if you meet the study's specific criteria. Participation involves regular clinic visits for assessments and drug administration (injections), while oral medications are taken at home. You will be randomly assigned to receive either the new drug combination or standard therapy, and both you and your doctor will know which treatment you are receiving. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 400 participants
Interventions
- DRUG: PF-07248144 — KAT6 inhibitor
- DRUG: Fulvestrant — Endocrine therapy
- DRUG: Everolimus — mTOR inhibitor
- DRUG: Exemestane — Endocrine therapy
Primary Outcomes
- Progression Free Survival (PFS) as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (From the date of randomization until disease progression or death due to any cause (up to approximately 2 years))
Secondary Outcomes
- Overall Survival (OS) (From the date of randomization until death due to any cause (up to approximately 5 years).)
- Number of Participants with Objective Response (OR) by BICR (From the date of randomization until disease progression or death due to any cause (up to approximately 2 years))
- Duration of Response (DoR) as defined by BICR (From the date of the first objective (PR or CR) response (every 8 weeks during the first 48 weeks and then every 12 week) up to approximately 2 years.)
- Number of Participants With Clinical Benefit Response (CBR) by BICR (From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) up to approximately 2 years.)
- Number or Patients with Adverse Events (AEs) by Type (From screening until 28 days after the last dose, to approximately 5 years)
Full 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.
Trial Locations
- Ironwood Cancer & Research Centers, Chandler, Arizona, United States
- Banner Gateway Medical Center, Gilbert, Arizona, United States
- Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
- Ironwood Cancer & Research Centers, Gilbert, Arizona, United States
- Ironwood Cancer & Research Centers, Glendale, Arizona, United States
- Ironwood Cancer & Research Centers, Goodyear, Arizona, United States
- Ironwood Cancer & Research Centers, Mesa, Arizona, United States
- Ironwood Cancer & Research Centers, Mesa, Arizona, United States
- Ironwood Cancer & Research Centers, Phoenix, Arizona, United States
- Ironwood Cancer & Research Centers, Scottsdale, Arizona, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT07062965?
NCT07062965 is a Phase 3 INTERVENTIONAL study titled "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.." It is currently recruiting and is sponsored by Pfizer. The trial targets enrollment of 400 participants.
What conditions does NCT07062965 study?
This trial investigates treatments for Breast Cancer. The primary condition under study is Breast Cancer.
What treatments are being tested in NCT07062965?
The interventions being studied include: PF-07248144 (DRUG), Fulvestrant (DRUG), Everolimus (DRUG), Exemestane (DRUG). KAT6 inhibitor
What does Phase 3 mean for NCT07062965?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT07062965?
This trial is currently "Recruiting." It started on 2025-08-05. The estimated completion date is 2030-11-04.
Who is sponsoring NCT07062965?
NCT07062965 is sponsored by Pfizer. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07062965?
The trial aims to enroll 400 participants. The trial is currently recruiting and accepting new participants.
How is NCT07062965 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07062965?
The primary outcome measures are: Progression Free Survival (PFS) as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (From the date of randomization until disease progression or death due to any cause (up to approximately 2 years)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07062965 being conducted?
This trial is being conducted at 20 sites, including Chandler, Arizona; Gilbert, Arizona; Glendale, Arizona; Goodyear, Arizona and 16 more sites (United States).
Where can I find official information about NCT07062965?
The official record for NCT07062965 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07062965. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07062965 testing in simple terms?
This trial tests a new drug, PF-07248144, combined with fulvestrant, against standard treatment for advanced breast cancer. It is for adults with hormone-receptor-positive, HER2-negative advanced or metastatic breast cancer that has worsened after prior treatment with CDK4/6 inhibitors.
Why is this trial significant?
This trial addresses a critical need for new treatments for patients whose advanced breast cancer has stopped responding to common therapies like CDK4/6 inhibitors. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT07062965?
Common side effects may include fatigue, nausea, diarrhea, and skin rash. Specific risks related to PF-07248144 are still being studied, but may include effects on blood cell counts or liver function. Fulvestrant injections can cause pain or irritation at the injection site. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07062965?
Ask your doctor if your cancer has progressed after CDK4/6 inhibitor therapy and if you meet the study's specific criteria. Participation involves regular clinic visits for assessments and drug administration (injections), while oral medications are taken at home. You will be randomly assigned to receive either the new drug combination or standard therapy, and both you and your doctor will know which treatment you are receiving. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07062965 signal from an investment perspective?
This trial targets a significant unmet need in a large breast cancer market, with a new drug class (KAT6 inhibitors) offering potential differentiation and a competitive advantage if successful. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participants will receive either the new drug combination or their doctor's choice of standard therapy, with treatments given by mouth and injection. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Breast Cancer Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.