Status:

RECRUITING

A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Breast Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

This study will evaluate mechanisms of resistance to anti-breast cancer therapies in tumor and blood samples from participants with human epidermal growth factor receptor (HER2) positive, hormone rece...

Eligibility Criteria

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

Key Trial Info

Start Date :

April 2 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 30 2026

Estimated Enrollment :

320 Patients enrolled

Trial Details

Trial ID

NCT06274515

Start Date

April 2 2024

End Date

September 30 2026

Last Update

April 6 2026

Active Locations (28)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 7 (28 locations)

1

Institut Jules Bordet

Anderlecht, Belgium, 1070

2

AZ KLINA

Brasschaat, Belgium, 2930

3

CHU de Liège (Sart Tilman)

Liège, Belgium, 4000

4

AZ Delta (Campus Rumbeke)

Roeselare, Belgium, 8800