Tracking Triple-negative Breast Cancer Evolution Through Therapy

NCT03077776 | Active Not Recruiting DMC

• 2 other identifiers: UC-0105/1614ID RCB: 2016-A01177-44
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 10

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.

Conditions

Triple-Negative Breast Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Invasive disease-free survival

  from surgery until 5 years post-surgery

• Overall survival

  from surgery until 5 years post-surgery

Study Arms (1)

All included patients

EXPERIMENTAL

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.

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

Interventions

Biopsy PROCEDURE

Biopsy of primary tumour to be performed prior to initiation of neoadjuvant chemotherapy

All included patients

Biopsy (optional) PROCEDURE

\[Optional\] biopsy of primary tumour to be performed after 4 weeks of neoadjuvant chemotherapy

All included patients

Biopsy (metastatic) PROCEDURE

Biopsy of metastatic site to be performed at the time of relapse

All included patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UNICANCER: lead
• National Cancer Institute, France: collaborator

Study Sites (10)

Centre Jean Perrin

Clermont-Ferrand, France

Location

Centre George François Leclerc

Dijon, France

Location

Centre Leon Bérard

Lyon, France

Location

Institut Paoli Calmettes

Marseille, France

Location

Institut de Cancerologie de l'Ouest

Nantes, France

Location

Centre Eugène Marquis

Rennes, France

Location

Centre Paul Strauss

Strasbourg, France

Location

Hopitaux universitaire de strasbourg - Hopital civil

Strasbourg, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

Location

Gustave Roussy

Villejuif, France

Location

Related Links

• UNICANCER official website

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Monica ARNEDOS, MD

  Gustave Roussy Cancer Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 13, 2017
• Study Start: April 14, 2017
• Primary Completion: June 1, 2024
• Study Completion: May 1, 2026
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

FR (10)