| Titre |
A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting |
| Protocole ID |
DESTINY-Breast06 |
| ClinicalTrials.gov ID |
NCT04494425 |
| Type(s) de cancer |
Sein |
| Phase |
Phase III |
| Type étude |
Clinique |
| Médicament |
Trastuzumab Deruxtecan versus traitement au choix de l'investigateur |
| Institution |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
 SITE GLEN
1001 boul. Décarie , Montréal, QC, H4A 3J1
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Jamil Asselah
|
| Coordonnateur(trice) |
Neera Sriskandarajah
514-934-1934 poste 36686
|
| Statut |
![]() Fermé |
| Critètes d'éligibilité |
- Patients must be ≥18 years of age
-
Pathologically documented breast cancer that:
- is advanced or metastatic
- has a history of HER2-low or negative expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or HER2 IHC 0 (ISH- or untested)
- has HER2-low or HER2 IHC >0 <1+ expression
- was never previously HER2-positive
- is documented HR+ disease in the metastatic setting.
- No prior chemotherapy for advanced or metastatic breast cancer.
- Has adequate tumor samples for assessment of HER2 status
-
Must have either:
- disease progression within 6 months of starting first line metastatic treatment with an endocrine therapy combined with a CDK4/6 inhibitor or
- disease progression on at least 2 previous lines of endocrine therapy with or without a targeted therapy in the metastatic setting. Of note with regards to the ≥2 lines of previous ET requirement: disease recurrence while on the first 24 months of starting adjuvant ET, will be considered a line of therapy; these patients will only require 1 line of ET in the metastatic setting.
- Has protocol-defined adequate organ and bone marrow function
|
| Critètes d'exclusion |
- Ineligible for all options in the investigator's choice chemotherapy arm
- Lung-specific intercurrent clinically significant illnesses
- Uncontrolled or significant cardiovascular disease or infection
- Active or prior documented interstitial lung disease (ILD)/pneumonitis or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
- Patients with spinal cord compression or clinically active central nervous system metastases
- Prior randomization or treatment in a previous trastuzumab deruxtecan study regardless of treatment arm assignment
|
Groupe d'étude en oncologie du Québec