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PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection

NCT03079011 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1017

Last updated 2025-11-18

No results posted yet for this study

Summary

This study is a randomized, open-label, multicentric, phase III trial conducted in patients receiving aromatase inhibitor and palbociclib as first line therapy for estrogen receptor (ER)-positive HER2-negative metastatic breast cancer and which aims to evaluate, at the onset of ESR1 mutations in circulating tumor DNA, the efficacy of a change of the hormone therapy (aromatase inhibitor (AI) changed to fulvestrant) combined to palbociclib, together with the safety of hormone therapy and palbociclib combination in the overall population.

Conditions

Interventions

DRUG

Palbociclib 125mg

Palbociclib 125 mg once daily for 21 days followed by 7 days off to complete a 28-day cycle

DRUG

Aromatase Inhibitors

Letrozole: 2.5 mg once daily on a continuous scheme (tablets, per os) Anastrozole:1 mg once daily on a continuous scheme (tablets , per os) Exemestane: 25 mg once daily on a continuous scheme (tablets, per os)

DRUG

Fulvestrant Injectable Product

500 mg by intramuscular injection on days 1 and 15 of cycle one and then on day one of each subsequent cycle (28 days)

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • UNICANCER

    lead OTHER

Principal Investigators

  • François-Clément BIDARD, MD PhD · Institut Curie

  • Suzette DELALOGE, MD PhD · Gustave Roussy, Cancer Campus, Grand Paris

  • Anne-Claire HARDY BESSARD, MD · Centre Armoricain d'Oncologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-22
Primary Completion
2021-04-30
Completion
2025-09-22

Countries

  • France

Study Locations

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Diseases
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 NCT03079011 on ClinicalTrials.gov