Tests PF-07248144 with fulvestrant in breast cancer after prior CDK4/6 treatment
Tests PF-07248144 with fulvestrant in adults with advanced HR-positive, HER2-negative breast cancer.
Key facts
- Who runs it
- Pfizer
- Where
- Besançon, Bordeaux, Brest, Bron, Caen Cedex 5, Lyon Cedex 04, Marseille, Montpellier Cedex 5, Paris, Pierre-Bénite, Rennes Cedex, Vandoeuvre Les Nancy_ Cedex, and Villejuif, FranceSee the 13 sitesAlso in 30 other countries, 413 sites
- Trial code
- Registry title
- 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.
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 400 people, planned
- Started
- 5 Aug 2025
- Expected to end
- 4 Nov 2030
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- PF-07248144
- Fulvestrant
- Everolimus
- Exemestane
- Record updated
- 19 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with HR-positive, HER2-negative breast cancer that has spread or is advanced, and that got worse after treatment with a CDK4/6 inhibitor.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- HR-positive, HER2-negative breast cancer that is locally advanced or metastatic and cannot be treated by surgery or radiation meant to remove all of the disease. Disease that can be measured, or bone-only disease. ECOG performance status 0 or 1.
- Earlier treatment
- Must have had a CDK4/6 inhibitor with endocrine therapy, with progression during treatment or within 12 months after the last dose. Cannot have had more than two earlier lines of systemic therapy for advanced or metastatic disease. Cannot have had chemotherapy, including antibody drug conjugates, for advanced or metastatic disease. Chemotherapy before or after surgery is allowed.
- Biomarker or test result
- Cannot join if tissue tests show PIK3CA, AKT1 or PTEN changes.
Main reasons for not taking part
- Detectable PIK3CA, AKT1 or PTEN changes in tissue
- More than two earlier lines of systemic therapy for advanced or metastatic disease
- Chemotherapy, including antibody drug conjugates, for advanced or metastatic disease
- A medical or psychiatric condition that may raise the risk of taking part
- Kidney problems, liver problems or blood count abnormalities
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Documented detectable PIK3CA/AKT1/PTEN alterations in tissue
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- What did the tests on your tumour show about hormone receptors and the HER2 protein?
- Have you already had any medicine for your cancer after it spread or became advanced?
- Have you been treated with a CDK4/6 inhibitor (for example palbociclib, ribociclib or abemaciclib)?
- Have you had chemotherapy for cancer that has spread or is advanced?
Where in France
Also in 30 other countries, 413 sites
- CHU BesançonBesançon, FranceTaking people
- Institut BergonieBordeaux, FranceTaking people
- Centre Hospitalier Régional et Universitaire de BrestBrest, FranceTaking people
- Hospices Civils de LyonBron, FranceTaking people
- Centre Francois BaclesseCaen Cedex 5, FranceTaking people
- Hopital De La Croix-RousseLyon Cedex 04, FranceTaking people
- Institut Paoli-CalmettesMarseille, FranceTaking people
- Institut Regional Du Cancer De MontpellierMontpellier Cedex 5, FranceTaking people
- Institut CurieParis, FranceTaking people
- Hospices Civils de LyonPierre-Bénite, FranceTaking people
- Centre De Lutte Contre Le Cancer Eugene MarquisRennes Cedex, FranceTaking people
- Institut de cancérologie de LorraineVandoeuvre Les Nancy_ Cedex, FranceTaking people
- Institut Gustave RoussyVillejuif, FranceTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Arm A: PF-07248144 plus fulvestrantOther group
PF-07248144 tablet taken by mouth plus fulvestrant taken as a shot into the muscle.
Treatment: PF-07248144 and Fulvestrant
- Arm B: everolimus plus ETExisting treatment, for comparison
Everolimus tablet taken by mouth plus investigator's choice of endocrine therapy of exemestane tablet taken by mouth or fulvestrant taken as a shot into the muscle.
Treatment: Fulvestrant, Everolimus, and Exemestane
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- Tests PF-07248144 with fulvestrant in breast cancer after prior CDK4/6 treatmentGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07062965, who can take part
- Record updated
- 19 October 2026