Predicting breast cancer treatment responses using advanced analysis techniques
Prediction in Silico of Pathological Response in a Prospective Cohort Study of Early Breast Cancer Patients
This study is testing if advanced analysis techniques can help predict how early breast cancer patients will respond to chemotherapy, especially for those with tougher subtypes like triple-negative and HER2-positive breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Cancerologie de l'Ouest Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Angers and 1 other locations) |
| Trial ID | NCT05981326 on ClinicalTrials.gov |
What this trial studies
This study aims to predict pathological responses in early breast cancer patients undergoing neoadjuvant chemotherapy by utilizing multi-omic analysis and a prospective clinico database. It focuses on evaluating the effectiveness of new therapeutic strategies guided by the patients' responses to treatment, particularly in subtypes such as triple-negative and HER2-positive breast cancer. Patients will undergo biopsies, blood sampling, and complete questionnaires to gather comprehensive data for analysis. The goal is to redefine prognostic factors and improve treatment outcomes for breast cancer patients.
Who should consider this trial
Good fit: Ideal candidates include adult women with histologically confirmed early breast cancer who require neoadjuvant chemotherapy and have no metastatic disease.
Not a fit: Patients with metastatic breast cancer or those with other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment strategies for breast cancer patients.
How similar studies have performed: Other studies have shown promising results using similar predictive approaches in breast cancer treatment, indicating potential for success in this study.
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 samples and questionnaires 2. 18 years old or at time of written consent 3. Patient with histologically confirmed breast cancer 4. Absence of metastatic disease 5. Patient requiring neoadjuvant chemotherapy 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. 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. 9. Patient must be affiliated to a Social Health Insurance 10. For patients taking part in the RTW WP: working patients at time of diagnostic and in sick leave at time of inclusion Exclusion Criteria: 1. Other malignancy treated within the last 5 years (except non-melanoma skin cancer or in situ carcinoma of the cervix) 2. Non epithelial breast cancer 3. Coagulopathy or other pathology that contraindicates biopsy procedures 4. Pregnant or nursing patient 5. Individual deprived of liberty or placed under the authority of a tutor 6. Impossibility to submit to the medical follow-up of this clinical trial for geographical, social or psychological reasons 7. For patients taking part in the RTW WP: patient in an "self employed" or "interim" employment situation 8. For patients taking part in the RTW WP: Patients working part-timeProcedures for withdrawal of incorrectly enrolled patients are presented in Section 7.5.
Where this trial is running
Angers and 1 other locations
- Institut de Cancérologie de l'Ouest — Angers, France (Recruiting)
- Institut de Cancérologie de l'Ouest — Saint-Herblain, France (Recruiting)
Study contacts
- Study coordinator: Jean Sebastien FRENEL, MD
- Email: jean-sebastien.frenel@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.