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Clinical Trial Evaluating the Biological Activity of a New Drug Identified as Prifetrastat (PF-07248144), Combined With Fulvestrant for the Treatment of Patients With Hormone Receptor Positive (HR+) and HER2 Negative (HER2-) Breast Cancer Extended to Other Organs.

NCT07340619 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2026-05-19

No results posted yet for this study

Summary

Although treatments for breast cancer have improved, 20-30% of patients with early disease develop metastases (cancer that spreads to other parts of the body). Among the different types of breast cancer, hormone-sensitive cancers that do not overexpress the HER2 protein (HR+/HER2-) are the most common. For patients with this type of cancer, an endocrine treatment such as aromatase inhibitors, tamoxifen or fulvestrant, is often used and may be combined with drugs called CDK4/6 inhibitors, which help improve survival rate. However, when the cancer becomes resistant to these treatments, treatment strategies are more limited

A new drug, prifetrastat (PF-07248144), which targets KAT6 proteins, which play a role in the growth of cancer cells, has shown promising results. Indeed, associated with fulvestrant, it allowed to fight against cancer in some patients who had already received many treatments.

The UNLOCK-EPIBREAST study aims to investigate whether the combination of prifetrastat plus fulvestrant could offer a new therapeutic option for people with HR+/HER2- metastatic breast cancer who have already received endocrine therapy plus CDK4/6 inhibitors.

Conditions

  • Metastatic (Stage IV) Melanoma

Interventions

DRUG

prifetrastat monotherapy for 15 days then combination with fulvestrant

Patients will receive prifetrastat 5mg QD monotherapy for 2 weeks and then combination of prifetrastat 5mg QD plus fulvestrant 500-mg intramuscular injection on day 15 cycle 1, on day 1 and day 15 of cycle 2 and then on day 15 of subsequent 28-day (±3 days) cycles.

DRUG

prifetrastat in combination with fulvestrant

Patients will receive combination prifetrastat 5mg QD plus fulvestrant 500-mg intramuscular injection on days 1 and 15 of cycle 1 and on day 1 of subsequent 28-day (±3 days) cycles

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • UNICANCER

    lead OTHER

Principal Investigators

  • Benjamin VERRET, MD · Gustave Roussy, Cancer Campus, Grand Paris

  • Fabrice ANDRE, MD · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-18
Primary Completion
2028-11-18
Completion
2029-11-18

Countries

  • France

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07340619 on ClinicalTrials.gov