Tracking Triple-negative Breast Cancer Evolution Through Therapy
- Conditions
- Triple-Negative Breast Neoplasm
- Registration Number
- NCT03077776
- Lead Sponsor
- UNICANCER
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 149
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method Invasive disease-free survival from surgery until 5 years post-surgery the time from neoadjuvant treatment initiation until the date of the first occurrence of one of the following events: invasive ipsilateral breast tumour recurrence (same breast), local /regional invasive recurrence, invasive contra lateral breast cancer, appearance of metastasis, second primary invasive cancer (non-breast cancer), ipsilateral ductal carcinoma in situ, contralateral ductal carcinoma in situ, death attributable to any cause.
Overall survival from surgery until 5 years post-surgery the time from neoadjuvant treatment until death due to any cause
Trial Locations
- Locations (10)
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
Centre Jean Perrin🇫🇷Clermont-Ferrand, France