Investigating why some breast cancer therapies stop working

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 evaluates the mechanisms behind resistance to breast cancer therapies by analyzing tumor and blood samples from participants diagnosed with HER2 positive, hormone receptor positive, or triple negative breast cancer. Participants will undergo procedures to obtain tumor tissue and blood samples, allowing researchers to study the biological factors contributing to treatment resistance. The study aims to enhance understanding of how these cancers respond to therapies and identify potential new treatment strategies.

Why it matters

Who can join: the full rules

General Inclusion Criteria:

* Willingness to undergo a procedure to obtain tumor tissue (e.g. biopsy) and blood draw
* Diagnosis of HER2+, HR+ (for cohort R1) or triple negative breast cancer (for cohort T1) as per local assessment
* Availability of an archival tumor tissue (most recent pre-treatment tumor tissue is preferred)
* Unequivocally growing tumor lesion (progressive lesion) that is accessible for resection, excision or core needle biopsy
* Discontinuation of prior anti-cancer treatment outlined below should not be longer than 4 weeks from participation in this study

Inclusion criteria for participants in the cohorts studying acquired resistance

* Participant had undergone regular monitoring for disease progression as per local practice (preferably every 3-6 months) while on most recent breast cancer therapy
* Accessible tumor lesion that newly appeared or a lesion that started to regrow while the participant was at least 6 months on therapy

Inclusion criteria for participants in the cohort studying primary resistance

* Accessible tumor lesion that continued to increase in size or a newly appearing lesion (as confirmed by routine tumor assessment) while treated for at least 4 weeks but less than 6 months on therapy

Exclusion Criteria:

* Any risks factors that increase the risk of complications associated with the procedure to obtain tumor tissue (e.g. bleeding disorders)
* Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study
* Participant has started treatment with subsequent anti-cancer therapy
* Participants whose progressive tumor lesion that is targeted for biopsy/resection is in the bone
* Discontinuation of treatment was due to a reason other than disease progression

Where it's running

• Institut Jules Bordet
  Anderlecht, Belgium Recruiting
• Az Klina
  Brasschaat, Belgium Recruiting
• CHU de Liège (Sart Tilman)
  Liège, Belgium Recruiting
• AZ Delta (Campus Rumbeke)
  Roeselare, Belgium Recruiting
• Sjællands Universitetshospital, Køge;Onkologisk Afdeling
  Køge, Denmark > Enter Text, Denmark Recruiting
• Aalborg Universitetshospital
  Aalborg, Denmark Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: WO44977 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. Only)

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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.