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Adjuvant Systemic Treatment for (ER)-Positive HER2-negative Breast Carcinoma in Women Over 70 According to Genomic Grade (GG): Chemotherapy + Endocrine Treatment Versus Endocrine Treatment

NCT01564056 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1989

Last updated 2025-06-26

No results posted yet for this study

Summary

The purpose of the study is to evaluate the benefit of adjuvant chemotherapy on overall survival for elderly patients with breast cancer, in a sub group with a high risk of relapse according to Genomic Grade test.

Conditions

Interventions

DRUG

HORMONOTHERAPY

Hormonotherapy will be administered during 5 years following chemotherapy when allocated. (Tamoxifen, aromatase inhibitor or sequential hormonotherapy) is left to the investigator judgement in both groups (I and II).

DRUG

CHEMOTHERAPY then HORMONOTHERAPY

CHEMOTHERAPY regimen will be chosen amongst the following ones: i) 4 cycles of TC (docetaxel + cyclophosphamide) * Docetaxel 75 mg/m² IV infusion at hospital every 21 days * Cyclophosphamide 600 mg/m² IV infusion at hospital every 21 days ii) 4 cycles of AC (doxorubicin + cyclophosphamide) * Doxorubicin 60 mg/m² IV infusion at hospital every 21 days * Cyclophosphamide 600 mg/m² IV infusion at hospital every 21 days iii) 4 cycles of MC (liposomal non pegylated doxorubicin \[Myocet®\]+ cyclophosphamide) * Myocet® 60 mg/m² IV infusion at hospital every 21 days * Cyclophosphamide 600 mg/m² IV infusion at hospital every 21 days HORMONOTHERAPY (Tamoxifen, aromatase inhibitor or sequential hormonotherapy) is left to the investigator judgement in both groups (I and II).

Sponsors & Collaborators

  • UNICANCER

    lead OTHER

Principal Investigators

  • Etienne Brain · Institut Curie, Saint Cloud

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-12
Primary Completion
2022-04-11
Completion
2026-03-31

Countries

  • Belgium
  • France

Study Locations

More Related Trials

Entities

Diseases

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 NCT01564056 on ClinicalTrials.gov