Ireland
--:--IST
Active, not recruiting Not applicable

Tracking Triple-negative Breast Cancer Evolution Through Therapy

NCT03077776 · tracked via the Priya Life Science France tracker
Sponsor
Phase
Not applicable
Started
2017-04-14
Last updated
2026-08-03

Condition(s) studied

Triple-Negative Breast Neoplasm

Investigational drug(s) / intervention(s)

BiopsyBiopsy (optional)Biopsy (metastatic)

Biopsy: Biopsy of primary tumour to be performed prior to initiation of neoadjuvant chemotherapy

Biopsy (optional): \[Optional\] biopsy of primary tumour to be performed after 4 weeks of neoadjuvant chemotherapy

Biopsy (metastatic): Biopsy of metastatic site to be performed at the time of relapse

Study summary

A prospective multicentre study which aims to examine the relationship between intratumour heterogeneity (ITH) and pathological response to neoadjuvant chemotherapy in patients with histological confirmation of triple-negative breast cancer (TNBC) who are eligible for neoadjuvant chemotherapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age 18-years or older 2. Patients with histological confirmation of invasive breast cancer with known receptor status suitable for neoadjuvant chemotherapy as assessed by the local investigator 3. Estrogen receptor (ER)- and progesterone receptor (PR)-negative as defined by ≤1% of positive staining on immunohistochemistry 4. Human epidermal growth factor receptor 2 (HER2)-negative as defined by American Society of Clinical Oncology / College of American Pathologists guidelines 5. T1c-4 tumours (including inflammatory cancers), with any nodal status non candidate for conservative surgery upfront. Bilateral or multifocal cancer is permitted provided that all sites are HER2-negative and at least one site is ER- and PR-negative. 6. Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses 7. Patient with social insurance coverage Exclusion Criteria: 1. Confirmed metastatic disease at initial presentation 2. Any contraindication to the biopsy procedure 3. Previous or current malignancies of other origin within the last 5 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin 4. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol 5. Individuals deprived of liberty or placed under the authority of a tutor

Primary outcome measure(s)

  • Rate of pathological complete response (pCR) — pCR will be defined at the time of surgery on the tumor specimen
    pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/Tis ypN0 in the current American Joint Committee on Cancer \[AJCC\] staging system)

Trial sites (10)

FacilityCityRegionStatus
Centre Jean Perrin Clermont-Ferrand France
Centre George François Leclerc Dijon France
Centre Leon Bérard Lyon France
Institut Paoli Calmettes Marseille France
Institut de Cancerologie de l'Ouest Nantes France
Centre Eugène Marquis Rennes France
Centre Paul Strauss Strasbourg France
Hopitaux universitaire de strasbourg - Hopital civil Strasbourg France
Institut de Cancérologie de Lorraine Vandœuvre-lès-Nancy France
Gustave Roussy Villejuif France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03077776 on ClinicalTrials.gov ↗ ← All trials in France