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 |
CIUSSS DE L'ESTRIE – CENTRE HOSP. UNIV. DE SHERBROOKE
HOPITAL FLEURIMONT
3001 12e Avenue Nord, Sherbrooke, QC, J1H 5N4
|
Ville |
Sherbrooke |
Investigateur(trice) principal(e) |
Dr Michel Pavic
|
Coordonnateur(trice) |
Anick Champoux
819-346-1110 poste 12811
|
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
|