| Titre |
A Phase 1b/2 Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination With Other Anti-cancer Agents in Patients With HER2-positive Metastatic Breast Cancer (DESTINY-Breast07) |
| Protocole ID |
DB-07 (DESTINY-Breast07) |
| ClinicalTrials.gov ID |
NCT04538742 |
| Type(s) de cancer |
Sein |
| Phase |
Phase I-II |
| Stade |
Métastatique |
| Type étude |
Clinique |
| Médicament |
Trastuzumab deruxtecan |
| Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dre Danielle Charpentier
|
| Coordonnateur(trice) |
Adeline Hamon
514-890-8000 poste 30737
|
| Statut |
![]() Fermé |
| Critètes d'éligibilité |
- Patients must be at least 18 years of age
-
Pathologically documented breast cancer that:
- Is advanced/unresectable (patients that can be treated with curative intent are not eligible) or metastatic
- HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local assessment
- Is documented as hormone receptor-positive (estrogen or progesterone receptor) or negative in the metastatic setting
- Patient must have adequate tumor sample for biomarker assessment
- ECOG Performance Status of 0 or 1
-
Part 1
- Disease progression on or after the last systemic therapy prior to starting study treatment
- At least 1 prior treatment line in metastatic setting required.
-
Part 2 (Modules 0 - 5)
a) No prior lines of therapy for advanced/MBC allowed
- Part 2 (Module 6 and 7) a) Zero or one prior lines of therapy for advanced/MBC allowed
CNS Inclusion
- Modules 0 - 5 Patients must have no brain metastases or stable brain metastases.
- Module 6 and 7 Patients must have untreated brain metastases not needing local therapy or previously treated brain metastases that have progressed since prior local therapy
|
| Critètes d'exclusion |
- Uncontrolled or significant cardiovascular disease
- Active or prior documented (non-infectious) ILD/pneumonitis that required steroids, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
- Lung-specific intercurrent clinically significant illnesses
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
- Spinal cord compression or a history of leptomeningeal carcinomatosis
- Prior treatment with immune checkpoint inhibitors
- Prior treatment with an ADC containing a topoisomerase I inhibitor
- Prior treatment with tucatinib
CNS Exclusion
- Modules 0 - 5: Has untreated brain metastasis
- Module 6 and 7: Ongoing use of systemic corticosteroids for control of symptoms of brain metastases or brain lesion thought to require immediate local therapy
|
Groupe d'étude en oncologie du Québec