A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT06274515

Studienbeginn:
April 2024

Letztes Update:
01.05.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 4

Sponsor:
Hoffmann-La Roche

Collaborator:
-

Studienleiter

Clinical Trials
Study Director
Hoffmann-La Roche

Kontakt

Reference Study ID Number: WO44977 https://forpatients.roche.com/
Kontakt:
Phone: 888-662-6728 (U.S. Only)
E-Mail: global-roche-genentech-trials@gene.com» Kontaktdaten anzeigen

Studienlocations
(3 von 9)

KEM/Evang. Kliniken Essen Mitte gGmbH; Klinik für Internistische Onkologie / Hämatologie
45136 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps

St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
50935 Koeln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps

Universitätsklinikum Mannheim; Frauenklinik
68167 Mannheim
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps

Helsinki University Central Hospital; Dept of Oncology
00029 Helsinki
FinlandRekrutierend» Google-Maps

Tampere University Hospital; Dept of Oncology
33520 Tampere
FinlandRekrutierend» Google-Maps

I.R.S.T Srl IRCCS; Oncologia Medica
47014 Meldola
ItalyRekrutierend» Google-Maps

Azienda Ospedaliero - Universitaria di Modena Policlinico
41110 Modena
ItalyRekrutierend» Google-Maps

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
00168 Rome
ItalyRekrutierend» Google-Maps

Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
20133 Milano
ItalyRekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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)

Studien-Arme

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.
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.

Geprüfte Regime

Tumor Tissue and Blood Draw:
Participants will have their blood drawn on the day a tissue sample is taken from a progressive tumor lesion.

Quelle: ClinicalTrials.gov

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