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)

A Phase 3 Open-label Trial of Neoadjuvant Trastuzumab Deruxtecan (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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2041210097

Enrollment

900

Registered

2021-11-02

Start date

2021-11-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER2-positive early breast cancer

Interventions

- 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 pe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
- 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 (+-28 days) for the first 3 years. For years 4 to 6 after the last dose of study treatment, followup visits will take place every 6 months (+-28 days) until study completion.	—

Measure

Time frame

- 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 (+-28 days) for the first 3 years. For years 4 to 6 after the last dose of study treatment, followup visits will take place every 6 months (+-28 days) until study completion.

—

Countries

Austria, Brazil, Bulgaria, Canada, China, Germany, India, Italy, Japan, Peru, Philppines, Poland, Russia, Saudi Arabia, South Korea, Spain, Taiwan, Thailand, USA

Contacts

Public ContactContact for Clinical Trial Information

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial_jp@daiichisankyo.com+81-3-6225-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026