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

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ClinicalTrials.gov Identifier: NCT06274515
Recruitment Status : Recruiting
First Posted : February 23, 2024
Last Update Posted : May 29, 2024
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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 receptor (HR) positive or triple negative breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Tumor Tissue and Blood Draw Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi Cohort Translational Research Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies
Actual Study Start Date : April 2, 2024
Estimated Primary Completion Date : January 28, 2027
Estimated Study Completion Date : January 28, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06274515


Contacts
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Contact: Reference Study ID Number: WO44977 https://forpatients.roche.com/ 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
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Finland
Helsinki University Central Hospital; Dept of Oncology Recruiting
Helsinki, Finland, 00029
Tampere University Hospital; Dept of Oncology Recruiting
Tampere, Finland, 33520
Germany
KEM/Evang. Kliniken Essen Mitte gGmbH; Klinik für Internistische Onkologie / Hämatologie Recruiting
Essen, Germany, 45136
St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe Recruiting
Koeln, Germany, 50935
Universitätsklinikum Mannheim; Frauenklinik Recruiting
Mannheim, Germany, 68167
Italy
I.R.S.T Srl IRCCS; Oncologia Medica Recruiting
Meldola, Emilia-Romagna, Italy, 47014
Azienda Ospedaliero - Universitaria di Modena Policlinico Recruiting
Modena, Emilia-Romagna, Italy, 41110
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Recruiting
Rome, Lazio, Italy, 00168
Ospedale San Raffaele S.r.l. - PPDS Recruiting
Milano, Lombardia, Italy, 20132
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1 Recruiting
Milano, Lombardia, Italy, 20133
Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche Recruiting
Milano, Lombardia, Italy, 20141
Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia Recruiting
Madrid, Spain, 28041
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT06274515    
Other Study ID Numbers: WO44977
First Posted: February 23, 2024    Key Record Dates
Last Update Posted: May 29, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases