Triple-Negative Breast Neoplasm
Conditions
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.
Interventions
PROCEDUREBiopsy
Biopsy of primary tumour to be performed prior to initiation of neoadjuvant chemotherapy
PROCEDUREBiopsy (optional)
\[Optional\] biopsy of primary tumour to be performed after 4 weeks of neoadjuvant chemotherapy
PROCEDUREBiopsy (metastatic)
Biopsy of metastatic site to be performed at the time of relapse
Sponsors
UNICANCER
National Cancer Institute, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORMonica ARNEDOS, MD
Gustave Roussy Cancer Campus
Outcome results
None listed