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June. 04, 2021

Sept. 07, 2023

jRCT2031210130

Phase III Study of Trastuzumab Deruxtecan (T-DXd) with or without Pertuzumab versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINY-Breast09)

Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer
(DESTINY-Breast09)

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

Not Recruiting

July. 01, 2021

Aug. 23, 2021
1134

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

- Patients must be >=18 years of age(>=20 years of age - applicable for Japan only)
- Pathologically documented breast cancer that:
1.is advanced or metastatic
2.is locally assessed and prospectively centrally confirmed as HER2-positive (IHC3+ or ISH+)
3.is documented by local testing as hormone receptor (HR)-positive or HR-negative disease in the metastatic setting
- No prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer or only 1 previous line of endocrine therapy in the metastatic setting. Participants who have received chemotherapy or HER2-targeted therapy in the neo-adjuvant or adjuvant setting are eligible if > 6 months from treatment to metastatic diagnosis.
- Has protocol-defined adequate organ and bone marrow function

- Ineligible for any of the agents on the study.
- Any substance abuse or other medical conditions that, in the investigator's opinion, may interfere with subject's participation or study results
- Patients with spinal cord compression or clinically active central nervous system metastases. Participants with clinically inactive brain metastases or treated brain metastases that are no longer symptomatic may be included in the study.
- Active or prior documented interstitial lung disease (ILD)/pneumonitis or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
- Prior randomization or treatment in a previous trastuzumab deruxtecan study regardless of treatment arm assignment

18age old over
130age old under

Both

Breast Cancer; HER2-positive; Metastatic

Experimental: Arm A
Trastuzumab deruxtecan (T-DXd) with pertuzumab-matching placebo
Drug: Trastuzumab deruxtecan
Administered by intravenous infusion
Other Name: DS-8201a; T-DXd

Drug: Placebo
Administered by intravenous infusion

Experimental: Arm B
Trastuzumab deruxtecan (T-DXd) with pertuzumab
Drug: Trastuzumab deruxtecan
Administered by intravenous infusion
Other Name: DS-8201a; T-DXd

Drug: Pertuzumab
Administered by intravenous infusion

Active Comparator: Arm C
Standard of care
Drug: Taxane
Investigator's choice of docetaxel or paclitaxel administered by intravenous infusion

Drug: Pertuzumab
Administered by intravenous infusion

Drug: Trastuzumab
Administered by intravenous infusion

Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment

1.Progression Free Survival (PFS) by Investigator assessment
2.Overall Survival (OS)
3.Objective Response Rate (ORR) by BICR and Investigator assessment
4.Duration of Response (DoR) by BICR and Investigator Assessment
5.Time to second progression or death (PFS2) by Investigator assessment
6.Health related quality of life (HRQoL) using the EORTC QLQ-C30
7.Time to deterioration in EORTC-QLQ-C30 scores
8.Health related quality of life (HRQoL) using the EORTC QLQ-BR45
9.Serum concentration of trastuzumab deruxtecan and pertuzumab
10.Immunogenicity of trastuzumab deruxtecan, alone or with pertuzumab
11.Safety and tolerability of trastuzumab deruxtecan, alone or with pertuzumab

Daiichi Sankyo Co., Ltd.
AstraZeneca
Applicable
Center Hospital of the National Center for Global Health and Medicine IRB
Toyama 1-21-1, Shinjuku-ku, Tokyo

+81-3-3202-7181

Approval

Yes

Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request 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 rerefer 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 individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (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. URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

NCT04784715
ClinicalTrials.gov

Argentina/ Canada/ China/Denmark/Hungary/ India/ Italy/Korea/Peru/Philippines/Russian Federation/Saudi Arabia/Saudi Arabia/ Spain/Sweden/Taiwan/Turkey/United Kingdom/United States

History of Changes

No Publication date
11 Sept. 07, 2023 (this page) Changes
10 Feb. 09, 2023 Detail Changes
9 Dec. 04, 2022 Detail Changes
8 Nov. 04, 2022 Detail Changes
7 Feb. 03, 2022 Detail Changes
6 Dec. 05, 2021 Detail Changes
5 Oct. 07, 2021 Detail Changes
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3 July. 30, 2021 Detail Changes
2 June. 30, 2021 Detail Changes
1 June. 04, 2021 Detail