TITRE |
(EN) A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Participants With High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast or Axillary Lymph Nodes Following Neoadjuvant Therapy (DESTINY-Breast05) |
PROTOCOLE ID |
DESTINY-Breast05 |
CLINICAL TRIAL.gov ID |
NCT04622319 |
TYPE(S) DE CANCER |
Sein |
PHASE |
Phase III |
TYPE D'ÉTUDE |
Clinique |
INSTITUTION |
CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL
3755 rue de la Côte Ste. Catherine
(514) 340-8222
|
VILLE |
Montréal
|
INVESTIGATEUR(RICE) PRINCIPAL(E) |
Stephanie Wong
|
COORDONATEUR(RICE) |
Gladys El Helou gelhelou@jgh.mcgill.ca 514-340-8222 poste 26581
|
STATUT |
Fermé
|
CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- Adults ≥18 years old (local regulatory requirements will apply if the legal age of consent for study participation is >18 years old)
-
Pathologically documented HER2-positive breast cancer (BC):
- HER2-positive expression defined as an immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) confirmed prior to study randomization
- Histologically confirmed invasive breast carcinoma
- Clinical stage at disease presentation: T1-4, N0-3, M0; patients presenting with T1N0 tumors are not eligible
-
Pathologic evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of neoadjuvant therapy meeting one of the following high-risk criteria:
- Inoperable breast cancer at presentation (prior to neoadjuvant therapy), defined as clinical stages T4, N0-3, M0 or T1-3, N2-3, M0
- Operable at presentation, defined as clinical stages T1-3,N0-1,M0, with axillary node positive disease (ypN1-3) following neoadjuvant therapy
-
Completion of neoadjuvant systemic chemotherapy, including taxane and HER2-directed treatment prior to surgery
- Systemic therapy must consist of at least 6 cycles of chemotherapy with a total duration of at least 16 weeks, including at least 9 weeks of trastuzumab (± pertuzumab) and at least 9 weeks of taxane based chemotherapy. Patients may have received an anthracycline as part of neoadjuvant therapy in addition to taxane chemotherapy.
- Adequate excision as confirmed per medical records: surgical removal of all clinically evident disease in the breast and lymph nodes.
- An interval of no more than 12 weeks between the date of last surgery and the date of randomization.
- Known hormone receptor (HR) status, per local laboratory assessment, as defined by ASCO-CAP guidelines (≥1%): HR positive status defined by either positive estrogen receptor (ER) and/or positive progesterone receptor (PR) status. HR-negative status defined by both known negative ER and known negative PR.
- Left ventricular ejection fraction (LVEF) ≥50% within 28 days prior to randomization.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at Screening.
- Has adequate organ function within 14 days before randomization.
|
CRITÈRES D'EXCLUSION |
(EN)
|