A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies (REMERGE)

June 3, 2026 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

320

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Study Locations

  • Belgium
      • Anderlecht, Belgium, 1070
        • Recruiting
        • Institut Jules Bordet
      • Brasschaat, Belgium, 2930
        • Recruiting
        • AZ Klina
      • Liège, Belgium, 4000
        • Recruiting
        • CHU de Liège (Sart Tilman)
      • Roeselare, Belgium, 8800
        • Recruiting
        • AZ Delta (Campus Rumbeke)
  • Denmark
      • Aalborg, Denmark, 9000
        • Recruiting
        • Aalborg Universitetshospital
      • Næstved, Denmark, 4700
        • Recruiting
        • Sjællands Universitetshospital, Næstved
  • Finland
      • Helsinki, Finland, 00029
        • Recruiting
        • Helsinki University Central Hospital
      • Tampere, Finland, 33520
        • Recruiting
        • Tampere University Hospital
  • Germany
      • Cologne, Germany, 50935
        • Recruiting
        • St. Elisabeth Krankenhaus Köln GmbH
      • Essen, Germany, 45136
        • Recruiting
        • KEM/Evang. Kliniken Essen Mitte gGmbH
      • Karlsruhe, Germany, 76135
        • Recruiting
        • ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG
      • Mannheim, Germany, 68167
        • Recruiting
        • Universitätsklinikum Mannheim
      • Ulm, Germany, 89075
        • Recruiting
        • Universitätsfrauenklinik Ulm
  • Italy
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • Recruiting
        • I.R.S.T Srl IRCCS
      • Modena, Emilia-Romagna, Italy, 41110
        • Recruiting
        • Azienda Ospedaliero - Universitaria di Modena Policlinico
    • Friuli Venezia Giulia
      • Aviano (PN), Friuli Venezia Giulia, Italy, 33081
        • Recruiting
        • RCCS - Centro di Riferimento
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    • Lombardy
      • Milan, Lombardy, Italy, 20141
        • Recruiting
        • Irccs Istituto Europeo di Oncologia (IEO)
      • Milan, Lombardy, Italy, 20133
        • Recruiting
        • Irccs Istituto Nazionale Dei Tumori (Int)
      • Milan, Lombardy, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele S.r.l. - PPDS
  • Norway
      • Oslo, Norway, 0424
        • Withdrawn
        • Oslo university hospital Radiumhospitalet
  • Spain
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28050
        • Recruiting
        • HM Sanchinarro ? CIOCC
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clínico Universitario de Valencia
  • United Kingdom
      • Basingstoke, United Kingdom, RG24 9NA
        • Recruiting
        • Basingstoke And North Hampshire Hospital
      • London, United Kingdom, W6 8RF
        • Recruiting
        • Imperial College Healthcare NHS Trust
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • Christie Hospital NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

January 24, 2024

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Actual)

February 23, 2024

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WO44977

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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