Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer
Phase 3
Active, not recruiting
- Conditions
- Breast NeoplasmsHER2-positive Early Breast CancerBreast Cancer
- Interventions
- Registration Number
- NCT05113251
- Lead Sponsor
- AstraZeneca
- Brief Summary
This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.
- Detailed Description
The target population of interest in this study is participants with high-risk HER2-positive early-stage breast cancer. The purpose of this study is to determine the efficacy and safety of T-DXd neoadjuvant therapy.
Participants will be randomised to one of 3 arms: T-DXd monotherapy (Arm A), T-DXd followed by THP (Arm B), or ddAC-THP (Arm C).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 927
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
- Adequate organ and bone marrow function
- LVEF ≥ 50% within 28 days before randomization
- FFPE tissue block (2 cores) or 20 freshly-cut, serial tumor slides for HER2 assessment by central lab. If blocks are incomplete or fewer than 20 slides are available, participants may be eligible following discussion with the AstraZeneca Study Physician
Read More
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) Note: 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
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B Trastuzumab T-DXd, followed by THP Arm C Paclitaxel doxorubicin and cyclophosphamide, followed by THP Arm A Trastuzumab Deruxtecan Trastuzumab deruxtecan Arm B Trastuzumab Deruxtecan T-DXd, followed by THP Arm B Paclitaxel T-DXd, followed by THP Arm B Pertuzumab T-DXd, followed by THP Arm C Trastuzumab doxorubicin and cyclophosphamide, followed by THP Arm C Pertuzumab doxorubicin and cyclophosphamide, followed by THP Arm C cyclophosphamide doxorubicin and cyclophosphamide, followed by THP Arm C Doxorubicin doxorubicin and cyclophosphamide, followed by THP
- Primary Outcome Measures
Name Time Method rate of pathologic complete response (pCR) Up to 39 months after study start Proportion of participants who have no evidence by H\&E staining of residual invasive disease
- Secondary Outcome Measures
Name Time Method Overall Survival Up to 72 months after study start Invasive Disease-Free Survival (IDFS) Up to 72 months after study start Event-Free Survival Up to 72 months after study start
Trial Locations
- Locations (1)
Research Site
🇹🇭Khon Kaen, Thailand
Related News
Current and future immunotherapy for breast cancer | springermedizin.de
Clinical trials for Sacituzumab govitecan, Trastuzumab emtansine, Trastuzumab deruxtecan, and other treatments show efficacy in various breast cancer types, with significant PFS and OS improvements.
- Prev
- 1
- Next