A Multi Cohort Translational Research Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies

Status: Recruiting
Location: See all (26) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 4
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 receptor (HR) positive or triple negative breast cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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

• 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

Locations
Other Locations
Belgium
Institut Jules Bordet
RECRUITING
Anderlecht
CHU de Liège (Sart Tilman)
RECRUITING
Liège
AZ Delta (Campus Rumbeke)
RECRUITING
Roeselare
Denmark
Aalborg Universitetshospital
RECRUITING
Aalborg
Sjællands Universitetshospital, Næstved
RECRUITING
Næstved
Finland
Helsinki University Central Hospital
RECRUITING
Helsinki
Tampere University Hospital
RECRUITING
Tampere
Germany
St. Elisabeth Krankenhaus Köln GmbH
RECRUITING
Cologne
KEM/Evang. Kliniken Essen Mitte gGmbH
RECRUITING
Essen
ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG
RECRUITING
Karlsruhe
Universitätsklinikum Mannheim
RECRUITING
Mannheim
Italy
RCCS - Centro di Riferimento
RECRUITING
Aviano (pn)
I.R.S.T Srl IRCCS
RECRUITING
Meldola
Irccs Istituto Europeo Di Oncologia (IEO)
RECRUITING
Milan
Irccs Istituto Nazionale Dei Tumori (Int)
RECRUITING
Milan
Ospedale San Raffaele S.r.l. - PPDS
RECRUITING
Milan
Azienda Ospedaliero - Universitaria di Modena Policlinico
RECRUITING
Modena
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Rome
Norway
Oslo university hospital Radiumhospitalet
WITHDRAWN
Oslo
Spain
HM Sanchinarro ? CIOCC
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Hospital Clínico Universitario de Valencia
RECRUITING
Valencia
United Kingdom
Basingstoke and North Hampshire Hospital
RECRUITING
Basingstoke
Imperial College Healthcare NHS Trust
RECRUITING
London
Christie Hospital NHS Trust
RECRUITING
Manchester
Contact Information
Primary
Reference Study ID Number: WO44977 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Time Frame
Start Date: 2024-04-02
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 320
Treatments
Experimental: Mechanisms of Acquired Resistance
Participants with breast cancer who have a newly appearing or recurrent metastatic lesion while on anti-cancer therapy will be assigned to one of 3 cohorts.
Experimental: Mechanisms of Primary Resistance
Participants with breast cancer who have a progressing tumor lesion while on anti-cancer therapy will be assigned to one of 2 cohorts.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov

Similar Clinical Trials