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NCT03958136Active, not recruiting

Clinico-biological Data Collection Study of Metastatic Breast Cancer

Prediction in Silico of Overall Survival in a Pilot Prospective Cohort Study of Metastatic Breast Cancer Patients

Source: ClinicalTrials.gov · Last updated 17 Aug 2025

Brief summary (registry, in English)

RATIONALE : Currently, the mechanisms associated with the response or resistance to treatment are poorly understood and are multifactorial. These mechanisms involve clinical and biological factors associated with the host and the tumor and possibly the patient's psycho-social environment. PURPOSE : This trial will assess the use of a prospective database dedicated to patients with breast cancers that contains clinical data as well as epidemiological, psychological, emotional, social, imaging, biological and bio-pathological data. These data will allow a creation of new modelling algorithms in order to predict response and resistance to treatment.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
289 (estimated)
First submitted
31 Dec 2018
Start date
24 Dec 2018
Primary completion date
24 Dec 2035
Lead sponsor
Institut Cancerologie de l'Ouest
NCT number
NCT03958136

What you commit to

  • Study type: Interventional
  • Planned participants: 289
  • From 24 Dec 2018 to the primary completion date, 24 Dec 2035
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior systemic treatment in metastatic setting
  • Patients with exclusive brain metastasis not available for surgery

Other illness

  • Other malignancy treated within the last 5 years (except non-melanoma skin cancer or in situ carcinoma of the cervix)

Other

  • Coagulopathy or other pathology that contraindicates biopsy procedures
  • Pregnant or nursing patient
  • Individual deprived of liberty or placed under the authority of a tutor
  • Impossibility to submit to the medical follow-up of this clinical trial for geographical, social or psychological reasons

Who the study is looking for

  • Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening biopsy, blood sample, faeces and questionnaires
  • Women \> 18 years old at time of written consent
  • Patient with histologically confirmed breast cancer
  • Breast cancer metastatic disease or locally advanced not eligible for local curative treatment intent with or without personal history of adjuvant therapy for this cancer (chemotherapy, radiotherapy, surgery …)
  • Patient with metastases that can be biopsied.
  • Performance status ≤ 2 (according to WHO criteria)
  • Indication of any systemic therapeutic strategy can be performed alongside this current cohort in accordance with national and / or international recommendations.
  • HR and HER2 status on metastatic sites or breast tumor if local recurrence:
    • For group 1 :
    • Histologic and/or cytological confirmation of estrogen-receptor positive (ER+) and/ or progesterone receptor positive (PR+) breast cancer determined by local laboratory testing
    • No HER2-overexpression in the patient's tumor tissue determined by local laboratory testing
    • For group 2 :
    • Histologic and/or cytological confirmation of estrogen-receptor positive or negative and/ or progesterone receptor positive or negative breast cancer determined by local laboratory testing
    • HER2-overexpression in the patient's tumor tissue determined by local laboratory testing
    • For group 3 :
    • Histologic and/or cytological confirmation of estrogen-receptor negative and progesterone receptor negative breast cancer determined by local laboratory testing
    • No HER2-overexpression in the patient's tumor tissue determined by local laboratory testing
  • Menopausal status : as per the institutional standard of care
  • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
  • Patient must be affiliated to a Social Health Insurance

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institut de Cacerologie de l'ouest - site Paul Papin
Coordinator of this site? Confirm its status
AngersFranceUnknown status
Institut de Cancérologie de l'Ouest
Coordinator of this site? Confirm its status
Saint-HerblainFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.