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Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib

NCT05625087 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2025-08-20

No results posted yet for this study

Summary

After an initial screening phase (SAFIR 03 - SCREENING) to identify patients with blood circulating mutated-PIK3CA tumours persistent, patients will be enrolled in the treatment phase of SAFIR 03 (SAFIR 03 - ARRIBA) that was designed as a randomised, open-label, multicentre, phase II study, for comparison of alpelisib to ribociclib in combination with fulvestrant (as the continuation of the CDK4/6 inhibitor-fulvestrant strategy) in terms of progression-free survival (PFS).

Conditions

  • Breast Cancer Stage IV

Interventions

DRUG

Alpelisib

Alpelisib 300 mg once daily + fulvestrant 500 mg every 28 days

DRUG

Ribociclib

Ribocilcib 600 mg once daily 3 weeks on/1 week off + fulvestrant 500 mg every 28 days

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Breast Cancer Research Foundation

    collaborator OTHER

  • UNICANCER

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-19
Primary Completion
2028-07-31
Completion
2030-06-30

Countries

  • France

Study Locations

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Drugs
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 NCT05625087 on ClinicalTrials.gov