A Phase 3 Trial of Neoadjuvant T-DXd Monotherapy or T-DXd followed by THP Compared to ddAC-THP in Participants with High-risk HER2-positive Early-stage Breast Cancer (DESTINY-Breast11)
- Conditions
- HER2-positive early breast cancer
- Registration Number
- JPRN-jRCT2041210097
- Lead Sponsor
- Inoguchi Akihiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 900
Key Inclusion Criteria:
- Patients must be at least 18 years of age.
- Histologically documented HER2-positive early breast cancer (EBC) participants, including clinical stage at presentation (based on mammogram or breast MRI assessment):
T0-4 (inclusive of inflammatory breast cancer), N1-3, M0 or >= T3, N0, M0 as determined by the AJCC staging system, 8th edition
- ECOG performance status of 0 or 1 at randomization
Exclusion Criteria:
- prior history of invasive breast cancer
- stage IV breast cancer (determined by AJCC staging system)
- any primary malignancy within 3 years (except resected non-melanoma skin cancer, curatively treated in situ disease). This includes a second current breast primary malignancy (ie, bilateral breast cancer).
- history of DCIS (except those treated with mastectomy >5 years prior to current diagnosis)
- History of, or current, ILD/pneumonitis
- Prior systemic therapy for the treatment of breast cancer
- Previous treatment with anthracyclines, cyclophosphamide or taxanes for any malignancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method rate of pathologic complete response (pCR) [ Time Frame: Following completion of neoadjuvant therapy ]<br>Proportion of participants who have no evidence by H&E staining of residual invasive disease
- Secondary Outcome Measures
Name Time Method - rate of pathologic complete response (pCR) [ Time Frame: Following completion of neoadjuvant therapy ]<br>- Event-Free Survival [ Time Frame: Three years ]<br>- Invasive Disease-Free Survival (IDFS) [ Time Frame: Three years ]<br>- Overall Survival [ Time Frame: End of Treatment and every 3 months after post-surgery follow-up for first 3 years. Then 6 months during years 4 and 5. ]