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

• ClinicalTrials.gov Identifier: NCT03077776
• Recruitment Status: Recruiting
• First Posted: March 13, 2017
• Last Update Posted: October 16, 2019
• Sponsor: UNICANCER
• Collaborator: National Cancer Institute, France
• Information provided by (Responsible Party): UNICANCER

Tracking Information

• First Submitted Date: March 1, 2017
• First Posted Date: March 13, 2017
• Last Update Posted Date: October 16, 2019
• Actual Study Start Date: April 14, 2017
• Estimated Primary Completion Date: January 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 10, 2017)

Rate of pathological complete response (pCR) [ Time Frame: 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)

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03077776 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: March 10, 2017)

• Invasive disease-free survival [ Time Frame: 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 [ Time Frame: from surgery until 5 years post-surgery ]
  the time from neoadjuvant treatment until death due to any cause

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Tracking Triple-negative Breast Cancer Evolution Through Therapy
• Official Title: Tracking Triple-negative Breast Cancer Evolution Through Therapy
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Triple-Negative Breast Neoplasm

Intervention

• Procedure: Biopsy
  Biopsy of primary tumour to be performed prior to initiation of neoadjuvant chemotherapy
• Procedure: Biopsy (optional)
  [Optional] biopsy of primary tumour to be performed after 4 weeks of neoadjuvant chemotherapy
• Procedure: Biopsy (metastatic)
  Biopsy of metastatic site to be performed at the time of relapse

Study Arms

Experimental: All included patients

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.

Interventions:

• Procedure: Biopsy
• Procedure: Biopsy (optional)
• Procedure: Biopsy (metastatic)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 10, 2017): 250
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2025
• Estimated Primary Completion Date: January 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Marta JIMENEZ; +33 (0)1 44 23 55 58; m-jimenez@unicancer.fr

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT03077776
• Other Study ID Numbers: UC-0105/1614; ID RCB: 2016-A01177-44 ( Other Identifier: ANSM )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: UNICANCER
• Study Sponsor: UNICANCER
• Collaborators: National Cancer Institute, France

Investigators

• Principal Investigator: Monica ARNEDOS, MD; Gustave Roussy Cancer Campus

• PRS Account: UNICANCER
• Verification Date: October 2019