Tracking Triple-negative Breast Cancer Evolution Through Therapy

UNICANCER10 sites in 1 country149 target enrollmentApril 14, 2017

ConditionsTriple-Negative Breast Neoplasm

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Triple-Negative Breast Neoplasm
Sponsor: UNICANCER
Enrollment: 149
Locations: 10
Primary Endpoint: Rate of pathological complete response (pCR)
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 14, 2017

End Date

May 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

UNICANCER

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18-years or older
•Patients with histological confirmation of invasive breast cancer with known receptor status suitable for neoadjuvant chemotherapy as assessed by the local investigator
•Estrogen receptor (ER)- and progesterone receptor (PR)-negative as defined by ≤1% of positive staining on immunohistochemistry
•Human epidermal growth factor receptor 2 (HER2)-negative as defined by American Society of Clinical Oncology / College of American Pathologists guidelines
•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.
•Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses
•Patient with social insurance coverage

Exclusion Criteria

•Confirmed metastatic disease at initial presentation
•Any contraindication to the biopsy procedure
•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
•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
•Individuals deprived of liberty or placed under the authority of a tutor

Outcomes

Primary Outcomes

Rate of pathological complete response (pCR)

Time Frame: 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)