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)

JRCT ID: jRCT2041210097

Registered date:02/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: HER2-positive early breast cancer
• Date of first enrollment: 16/11/2021
• Target sample size: 900
• Countries of recruitment: Italy,Japan,India,Japan,Canada,Japan,South Korea,Japan,Saudi Arabia,Japan,Spain,Japan,Philppines,Japan,Thailand,Japan,Taiwan,Japan,China,Japan,Germany,Japan,Austria,Japan,Bulgaria,Japan,USA,Japan,Poland,Japan,Brazil,Japan,Peru,Japan,Russia,Japan
• Study type: Interventional

Intervention(s)

- Arm A: T-DXd (5.4 mg/kg Q3W) x 8 cycles.
- Arm B: T-DXd (5.4 mg/kg Q3W) x 4 cycles followed by paclitaxel (80 mg/m2 QW on Days 1, 8, and 15) concurrent with trastuzumab (6 mg/kg Q3W on Day 1) and pertuzumab (840 mg loading dose followed by 420 mg Q3W on Day 1) x 4 cycles.
- Arm C: Doxorubicin (60 mg/m2 Q2W) and cyclophosphamide (600 mg/m2 Q2W) x 4 cycles followed by paclitaxel (80 mg/m2 QW on Days 1, 8, and 15) concurrent with trastuzumab (8 mg/kg loading dose followed by 6 mg/kg Q3W on Day 1) and pertuzumab (840 mg loading dose followed by 420 mg Q3W on Day 1) x 4 cycles.

Outcome(s)

Primary Outcome

rate of pathologic complete response (pCR) [ Time Frame: Following completion of neoadjuvant therapy ]
Proportion of participants who have no evidence by H&E staining of residual invasive disease

Secondary Outcome

- rate of pathologic complete response (pCR) [ Time Frame: Following completion of neoadjuvant therapy ]
- Event-Free Survival [ Time Frame: Three years ]
- Invasive Disease-Free Survival (IDFS) [ Time Frame: Three years ]
- 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. ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Inoguchi Akihiro
• Secondary Sponsor: AstraZeneca