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Efficacy of Letrozole + Palbociclib Combination as Neoadjuvant Treatment of Stage II-IIIA PAM 50 ROR-defined Low or Intermediate Risk Luminal Breast Cancer, in Postmenopausal Women

NCT02400567 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2022-03-15

No results posted yet for this study

Summary

The investigators propose in the present study an innovative approach, combining the most recent therapeutic opportunities in high risk ER+ breast cancer with the most recent and innovative diagnostic approaches such as the PAM50 signature and the RCB tumor response evaluation method. In line with the most recent recommendations on targeted anticancer therapies, the investigators have designed a parallel phase II randomized trial with early stopping rules 26, which will able in the meantime to build a unique prospective collection of tumor tissue, pre- and post-treatment.

Conditions

  • Neoadjuvant Operable Breast Cancer

Interventions

DRUG

Fluorouracile

DRUG

Epirubicin

DRUG

Cyclophosphamide

DRUG

Letrozole

DRUG

Palbociclib

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • NanoString Technologies, Inc.

    collaborator INDUSTRY

  • UNICANCER

    lead OTHER

Principal Investigators

  • Paul Cottu, MD · Institut Curie Paris

  • Suzette Delaloge, MD · Gustave roussy, Villejuif

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2018-01-31
Completion
2020-09-30

Countries

  • France

Study Locations

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Entities

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 NCT02400567 on ClinicalTrials.gov