Predicting breast cancer treatment responses using advanced analysis techniques

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.