jRCT ロゴ

臨床研究等提出・公開システム

Top

Japanese

Nov. 02, 2021

Dec. 13, 2023

jRCT2041210097

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)

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)

Inoguchi Akihiro

DAIICHI SANKYO Co.,Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

+81-3-6225-1111

dsclinicaltrial@daiichisankyo.co.jp

Contact for Clinical Trial Information

DAIICHI SANKYO Co.,Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

+81-3-6225-1111

dsclinicaltrial@daiichisankyo.co.jp

Recruiting

Nov. 15, 2021

Nov. 16, 2021
900

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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

18age old over
No limit

Both

HER2-positive early breast cancer

- 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.

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

- 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. ]

Daiichi Sankyo Co., Ltd.
AstraZeneca
Applicable
Nagoya City University Institutional Review Board
1 Kawasumi Mizuho-cho, Mizuho-ku, Nagoya, Aichi 467-8602, Aichi

+81-52-851-5511

clinical_research@med.nagoya-cu.ac.jp
Approval

Yes

Plan Description: Qualified researchers can request access to anonymized individual patient data from AstraZeneca Group of Companies, sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ Disclosure Commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Supporting Materials: Study Protocol Statistical Analysis Plan (SAP) Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Access Criteria: When a request has been approved, AstraZeneca will provide access to the de-identified patient level data in an approved sponsor tool. Signed Data Sharing Agreements (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

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

History of Changes

No Publication date
8 Dec. 13, 2023 (this page) Changes
7 Oct. 24, 2023 Detail Changes
6 July. 14, 2023 Detail Changes
5 Sept. 06, 2022 Detail Changes
4 June. 09, 2022 Detail Changes
3 Feb. 03, 2022 Detail Changes
2 Dec. 17, 2021 Detail Changes
1 Nov. 02, 2021 Detail