A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies

Breast Cancer Clinical Trial

— REMERGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06274515
• Other study ID #: WO44977
• Status: Recruiting
• Phase: Phase 4
• Start date: April 2, 2024
• Est. completion date: January 28, 2027

Study information

• Verified date: May 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: WO44977 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S. Only)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: January 28, 2027
• Est. primary completion date: January 28, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Tumor Tissue and Blood Draw
Participants will have their blood drawn on the day a tissue sample is taken from a progressive tumor lesion.

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital; Dept of Oncology	Helsinki
Finland	Tampere University Hospital; Dept of Oncology	Tampere
Germany	KEM/Evang. Kliniken Essen Mitte gGmbH; Klinik für Internistische Onkologie / Hämatologie	Essen
Germany	St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe	Koeln
Germany	Universitätsklinikum Mannheim; Frauenklinik	Mannheim
Italy	I.R.S.T Srl IRCCS; Oncologia Medica	Meldola	Emilia-Romagna
Italy	Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche	Milano	Lombardia
Italy	Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1	Milano	Lombardia
Italy	Ospedale San Raffaele S.r.l. - PPDS	Milano	Lombardia
Italy	Azienda Ospedaliero - Universitaria di Modena Policlinico	Modena	Emilia-Romagna
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Lazio
Spain	Hospital Universitario 12 de Octubre; Servicio de Oncologia	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Finland,  Germany,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2)		At least 6 months
Primary	Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohorts H1 and H2)		At least 6 months
Primary	Changes from baseline in estrogen receptor (ER) protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2)		At least 6 months
Primary	Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohort H3)		Less than 6 months
Primary	Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohort H3)		Less than 6 months
Primary	Changes from baseline in ER protein levels measured at the time of disease progression/recurrence (Cohort H3)		Less than 6 months
Primary	Changes from baseline in genes related to CDK4/6 resistance (incl. cell cycle alterations and tyrosine kinase receptors, Cohort R1)		At least 6 months
Primary	Changes from baseline in genes related to endocrine resistance (incl. cell cycle alterations and tyrosine kinase receptors, Cohort R1)		At least 6 months
Primary	Changes from baseline in tumor immune microenvironment (PD-L1 and TILs, Cohort T1)		At least 6 months
Primary	Changes from baseline in immune phenotype (PD-L1 and TILs, Cohort T1)		At least 6 months