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Neoadjuvant Phase II Trial in Patients With T1c Operable, HER2-positive Breast Cancer According to TOP2A Status

NCT02339532 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2024-11-08

No results posted yet for this study

Summary

The main objective of this multicenter study will therefore be to evaluate pathologic complete response rates of an anthracycline-based regimen \[FEC 100 - TAXOTERE® - HERCEPTIN® - PERTUZUMAB\] and a non anthracycline-based regimen \[TAXOTERE® - CARBOPLATINE - HERCEPTIN® - PERTUZUMAB\] according to the presence or not of TOP2A gene amplification in a population of breast cancer patients with HER2 overexpression.

A very important objective of the study will be the evaluation of biomarkers that predict response to treatment.

Conditions

Interventions

DRUG

FEC100

3 cycles of FEC 100 administered IV q3w * 5-Fluorouracil (5-FU) 500 mg/m² * Epirubicin 100 mg/m² * Cyclophosphamide 500 mg/m²

DRUG

Docetaxel

TOP2A amplified : DOCETAXEL 75 mg/m² IV escalating at 100 mg/m² IV as tolerated q3w TOP2A not amplified : DOCETAXEL 75 mg/m² IV

DRUG

Trastuzumab

Trastuzumab 8 mg/kg loading dose administered intravenously (IV) followed by 6 mg/kg IV q3w in subsequent cycles.

DRUG

Pertuzumab

Pertuzumab 840 mg loading dose administered IV followed by 420 mg IV q3w in subsequent cycles.

DRUG

Carboplatin

CARBOPLATIN AUC 6 IV q3w

Sponsors & Collaborators

  • UNICANCER

    lead OTHER

Principal Investigators

  • Marie-Ange MOURET REYNIER · Centre Jean Perrin

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2019-10-07
Completion
2024-07-08

Countries

  • France

Study Locations

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Entities

Drugs
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 NCT02339532 on ClinicalTrials.gov