Tracking Triple-negative Breast Cancer Evolution Through Therapy

Triple-Negative Breast Neoplasm Clinical Trial

— TRACERX-TNBC  

Official title:

Tracking Triple-negative Breast Cancer Evolution Through Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03077776
• Other study ID #: UC-0105/1614
• Secondary ID: ID RCB: 2016-A01
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 14, 2017
• Est. completion date: May 2026

Study information

• Verified date: April 2024
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 149
• Est. completion date: May 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Neoplasms
• Triple-Negative Breast Neoplasm

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
France	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

Sponsors (2)

Lead Sponsor	Collaborator
UNICANCER	National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of pathological complete response (pCR)	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)	pCR will be defined at the time of surgery on the tumor specimen
Secondary	Invasive disease-free survival	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.	from surgery until 5 years post-surgery
Secondary	Overall survival	the time from neoadjuvant treatment until death due to any cause	from surgery until 5 years post-surgery

External Links

•   UNICANCER official website