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NCT Number: NCT06274515

A 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institut Jules Bordet, Anderlecht, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tumor Tissue and Blood Draw

Procedure

Participants will have their blood drawn on the day a tissue sample is taken from a progressive tumor lesion.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohort H3)

    Time frame: Less than 6 months

  5. Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohort H3)

    Time frame: Less than 6 months

  6. Changes from baseline in ER protein levels measured at the time of disease progression/recurrence (Cohort H3)

    Time frame: Less than 6 months

  7. 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

  8. 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

  9. Changes from baseline in tumor immune microenvironment (PD-L1 and TILs, Cohort T1)

    Time frame: At least 6 months

  10. Changes from baseline in immune phenotype (PD-L1 and TILs, Cohort T1)

    Time frame: At least 6 months

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Acronym: REMERGE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 23, 2024
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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