Clinical trial NCT03077776: Tracking Triple-negative Breast Cancer Evolution Through Therapy
Official title: Tracking Triple-negative Breast Cancer Evolution Through Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Triple-Negative Breast Neoplasm
Lead sponsor: UNICANCER
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
First posted: 2017-03-13
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Rate of pathological complete response (pCR)
timeFrame: pCR will be defined at the time of surgery on the tumor specimen
Secondary outcomes:
measure: Invasive disease-free survival
timeFrame: from surgery until 5 years post-surgery
measure: Overall survival
timeFrame: from surgery until 5 years post-surgery
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: Centre George François Leclerc
city: Lyon
country: France
facility: Centre Leon Bérard
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Nantes
country: France
facility: Institut de Cancerologie de l'Ouest
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Strasbourg
country: France
facility: Hopitaux universitaire de strasbourg - Hopital civil
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
affiliation: Gustave Roussy Cancer Campus
name: Monica ARNEDOS, MD
role: PRINCIPAL_INVESTIGATOR
References: