Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Pfizer (Voir sur ClinicalTrials)
août 2025
novembre 2030
07 mai 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Cyril ROUSSEL SIMONIN | 18/05/2026 12:10:05 | Contacter | ||
Critères
Tous
- 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.