臨床研究等提出・公開システム

An Open-Label, Multinational, Multicenter, Phase 3b/4 Study of Trastuzumab Deruxtecan in Patients With or Without Baseline Brain Metastasis with Previously-Treated Advanced/Metastatic HER2-Positive Breast Cancer (DESTINY-Breast12)

A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer (DESTINY-Breast 12)

Hanai Masaharu

DAIICHI SANKYO Co.,Ltd.

3-5-1, Nihonbashihoncho, Chuo-ku, Tokyo

dsclinicaltrial@daiichisankyo.co.jp

Contact for Clinical Trial Information

DAIICHI SANKYO Co.,Ltd.

3-5-1, Nihonbashihoncho, Chuo-ku, Tokyo

+81-3-6225-1111

dsclinicaltrial@daiichisankyo.co.jp

Complete

Aug. 01, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

-Participant must be >= 18 years at the time of screening.
Pathologically documented breast cancer that
-Is unresectable/advanced or metastatic, and
-Has confirmed HER2-positive status as determined according to ASCO/CAP guidelines
Participant must have untreated BM on screening contrast brain MRI/CT scan
(i)not needing immediate local therapy, or
(ii)For participants with untreated CNS lesions > 2.0 cm, discussion with and approval from the study physician is required prior to enrollment
Previously-treated stable or progressing BM
(i) Previously-treated BM with local therapy may either be radiographically stable for >= 4 weeks since treatment or may have progressed since prior local CNS therapy, provided that there is no clinical indication for immediate re-treatment with local therapy
(ii) Patients treated with CNS local therapy for newly identified lesions found on contrast brain MRI/CT scan performed during screening
-ECOG performance status 0-1
-Previous breast cancer treatment
(i)Radiologic or objective evidence of disease progression on trastuzumab, pertuzumab, or T-DM1.
(ii)No more than 2 lines/regimens of therapy in the metastatic setting.
-Adequate organ and bone marrow function

-Known or suspected LMD.
-Participants with a medical history of myocardial infarction within 6 months before screening, symptomatic CHF (NYHA Class II to IV), unstable angina pectoris, or a recent (< 6 months) cardiovascular event including stroke.
-History of (non-infectious) ILD/pneumonitis that required steroids, has current
-ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
Lung criteria:
(i) Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of study
enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc)
(ii) Any autoimmune, connective tissue or inflammatory disorders (ie, rheumatoid arthritis, Sjogren's, sarcoidosis, etc.) where there is documented, or a suspicion of pulmonary involvement at the time of screening. Full details of the disorder should be recorded in the eCRF for participants who are included in the study.
(iii) Prior pneumonectomy
-Participation in another clinical study with a study intervention or investigational medicinal device administered in the last 30 days or 5 half-lives, whichever is longer, prior to first dose of study intervention, randomization into a prior T-DXd study regardless of treatment assignment, or concurrent enrollment in another clinical study,
unless it is an observational (noninterventional) clinical study or during the follow-up period of an interventional study.

Both

Breast Cancer

Drug: Trastuzumab Deruxtecan
Participants will receive T-DXd administered using an IV bag containing 5% (w/v) dextrose injection infusion solution.

-Objective Response Rate (ORR) in Participants without BM at Baseline (Cohort 1)
-Progression-free Survival in Participants with BM at Baseline (Cohort 2)

Participants in both cohorts:
-OS
-DoR by RECIST per ICR
-Time to progression by RECIST per ICR
-DoT on subsequent lines of therapy
-PFS2
Participants without BM at baseline (Cohort 1):
-Incidence of new symptomatic CNS metastasis during treatment
In patients who develop isolated CNS progression, receive local therapy, and continue on protocol therapy:
-Time to next progression (CNS or extracranial) or death
-Site (CNS vs extracranial vs both) of next progression

+81-3-3784-8000

Yes

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 requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. 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 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

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