Data collection for patients with metastatic breast cancer
Prediction in Silico of Overall Survival in a Pilot Prospective Cohort Study of Metastatic Breast Cancer Patients
This study is trying to gather detailed information from patients with metastatic breast cancer to help create personalized treatment plans based on their specific characteristics.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Institut Cancerologie de l'Ouest Academic / other |
| Drugs / interventions | chemotherapy, Trastuzumab, Pertuzumab, Bevacizumab |
| Locations | 2 sites (Angers and 1 other locations) |
| Trial ID | NCT03958136 on ClinicalTrials.gov |
What this trial studies
This study aims to create a comprehensive database for patients with metastatic breast cancer, collecting clinical, biological, psychological, and social data. It will categorize patients into three phenotypic groups based on their hormone receptor and HER2 status, guiding treatment protocols accordingly. The goal is to develop predictive algorithms that can better understand treatment responses and resistance mechanisms. By analyzing various factors, the study seeks to enhance personalized treatment approaches for patients.
Who should consider this trial
Good fit: Ideal candidates are women over 18 years old with histologically confirmed metastatic breast cancer who can provide informed consent.
Not a fit: Patients with non-metastatic breast cancer or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies and outcomes for patients with metastatic breast cancer.
How similar studies have performed: Other studies have shown promise in using comprehensive data collection and analysis to improve treatment outcomes in cancer, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening biopsy, blood sample, faeces and questionnaires
2. Women \> 18 years old at time of written consent
3. Patient with histologically confirmed breast cancer
4. 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 ...)
5. Patient with metastases that can be biopsied.
6. Performance status ≤ 2 (according to WHO criteria)
7. Indication of any systemic therapeutic strategy can be performed alongside this current cohort in accordance with national and / or international recommendations.
8. 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
9. Menopausal status : as per the institutional standard of care
10. 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.
11. Patient must be affiliated to a Social Health Insurance
Exclusion Criteria:
1. Other malignancy treated within the last 5 years (except non-melanoma skin cancer or in situ carcinoma of the cervix)
2. Coagulopathy or other pathology that contraindicates biopsy procedures
3. Prior systemic treatment in metastatic setting
4. Patients with exclusive brain metastasis not available for surgery
5. Pregnant or nursing patient
6. Individual deprived of liberty or placed under the authority of a tutor
7. Impossibility to submit to the medical follow-up of this clinical trial for geographical, social or psychological reasons
Where this trial is running
Angers and 1 other locations
- Institut de Cacerologie de l'ouest - site Paul Papin — Angers, France (Recruiting)
- Institut de cancerologie de l'Ouest — Saint Herblain, France (Recruiting)
Study contacts
- Principal investigator: Mario CAMPONE, MD, PhD — Institut de Cancerologie de l'Ouest
- Study coordinator: Mario CAMPONE, MD, PhD
- Email: mario.campone@ico.unicancer.fr
- Phone: +33240679900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.