WO44977 - A Multi Cohort Translational Research Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies (REMERGE)

Studio Clinico

Patologia: Neoplasie della mammella

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: IV

Richiesta mandatoria di tessuto: Sì

Linee di trattamento: Non applicabile

Criteri di inclusione: 

- 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

Criteri di esclusione: 

- 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

Trattamento sperimentale: 

- 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

- 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

Trattamento di controllo: 

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Centri partecipanti

Nord Italia

Centro Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT06274515

Data di inserimento: 04.10.2024

Data di aggiornamento: 15.11.2024

Promotore

Hoffmann-La Roche

Principal Investigator ITALIA

Riferimento: Dr. Info non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: nd