Tracking Triple-negative Breast Cancer Evolution Through Therapy (TRACERX-TNBC)

Unicancer

Status: Active, not recruiting

Conditions: Triple-Negative Breast Neoplasm

Treatments: Procedure: Biopsy (metastatic); Procedure: Biopsy; Procedure: Biopsy (optional)

Study type: Interventional

Funder types: Other

Identifiers

NCT03077776

ID RCB: 2016-A01177-44 (Other Identifier)

UC-0105/1614

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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149 participants in 1 patient group

All included patients

Experimental group

Description:

Patients will undergo a biopsy and provide a blood sample prior to initiating standard neoadjuvant chemotherapy. Additional tissue samples will be collected at the following time points: 1. (optional) biopsy of primary tumour after 4 cycles of neoadjuvant chemotherapy 2. At the time of surgery (samples of the primary tumour and lymph nodes which are surplus to diagnostic requirements). 3. Biopsy of a metastatic site in the event of disease recurrence. Blood samples will be obtained during neoadjuvant chemotherapy, prior to surgery and at 6-month intervals for up to 5 years post-surgery. In the event of recurrent disease, blood samples will be collected i) at the time of recurrence, ii) at the first CT scan on treatment and iii) at each subsequent relapse for up to 5 years post-surgery.

Treatment:

Procedure: Biopsy (optional)

Procedure: Biopsy

Procedure: Biopsy (metastatic)