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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mechanisms of Acquired Resistance | Experimental | 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. |
|
| Mechanisms of Primary Resistance | Experimental | Participants with breast cancer who have a progressing tumor lesion while on anti-cancer therapy will be assigned to one of 2 cohorts. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2) | At least 6 months | |
| Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohorts H1 and H2) | 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) | At least 6 months | |
| Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohort H3) | Less than 6 months | |
| Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohort H3) | Less than 6 months | |
| Changes from baseline in ER protein levels measured at the time of disease progression/recurrence (Cohort H3) | Less than 6 months | |
| Changes from baseline in genes related to CDK4/6 resistance (incl. cell cycle alterations and tyrosine kinase receptors, Cohort R1) | At least 6 months | |
| Changes from baseline in genes related to endocrine resistance (incl. cell cycle alterations and tyrosine kinase receptors, Cohort R1) | At least 6 months | |
| Changes from baseline in tumor immune microenvironment (PD-L1 and TILs, Cohort T1) |
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General Inclusion Criteria:
Inclusion criteria for participants in the cohorts studying acquired resistance
Inclusion criteria for participants in the cohort studying primary resistance
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: WO44977 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 (U.S. Only) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Jules Bordet | Recruiting | Anderlecht | 1070 | Belgium | ||
| AZ KLINA |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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| At least 6 months |
| Changes from baseline in immune phenotype (PD-L1 and TILs, Cohort T1) | At least 6 months |
| Recruiting |
| Brasschaat |
| 2930 |
| Belgium |
| CHU de Liège (Sart Tilman) | Recruiting | Liège | 4000 | Belgium |
| AZ Delta (Campus Rumbeke) | Recruiting | Roeselare | 8800 | Belgium |
| Aalborg Universitetshospital | Recruiting | Aalborg | 9000 | Denmark |
| Sjællands Universitetshospital, Næstved | Recruiting | Næstved | 4700 | Denmark |
| Helsinki University Central Hospital | Recruiting | Helsinki | 00029 | Finland |
| Tampere University Hospital | Recruiting | Tampere | 33520 | Finland |
| St. Elisabeth Krankenhaus Köln GmbH | Recruiting | Cologne | 50935 | Germany |
| KEM/Evang. Kliniken Essen Mitte gGmbH | Recruiting | Essen | 45136 | Germany |
| ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG | Recruiting | Karlsruhe | 76135 | Germany |
| Universitätsklinikum Mannheim | Recruiting | Mannheim | 68167 | Germany |
| Universitätsfrauenklinik Ulm | Recruiting | Ulm | 89075 | Germany |
| I.R.S.T Srl IRCCS | Recruiting | Meldola | Emilia-Romagna | 47014 | Italy |
| Azienda Ospedaliero - Universitaria di Modena Policlinico | Recruiting | Modena | Emilia-Romagna | 41110 | Italy |
| RCCS - Centro di Riferimento | Recruiting | Aviano (PN) | Friuli Venezia Giulia | 33081 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Rome | Lazio | 00168 | Italy |
| Ospedale San Raffaele S.r.l. - PPDS | Recruiting | Milan | Lombardy | 20132 | Italy |
| Irccs Istituto Nazionale Dei Tumori (Int) | Recruiting | Milan | Lombardy | 20133 | Italy |
| Irccs Istituto Europeo Di Oncologia (IEO) | Recruiting | Milan | Lombardy | 20141 | Italy |
| Oslo university hospital Radiumhospitalet | Withdrawn | Oslo | 0424 | Norway |
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| HM Sanchinarro ? CIOCC | Recruiting | Madrid | 28050 | Spain |
| Hospital Universitario Virgen del Rocio | Recruiting | Seville | 41013 | Spain |
| Hospital Clínico Universitario de Valencia | Recruiting | Valencia | 46010 | Spain |
| Basingstoke and North Hampshire Hospital | Recruiting | Basingstoke | RG24 9NA | United Kingdom |
| Imperial College Healthcare NHS Trust | Recruiting | London | W6 8RF | United Kingdom |
| Christie Hospital NHS Trust | Recruiting | Manchester | M20 4BX | United Kingdom |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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