臨床研究等提出・公開システム

A PHASE 3, MULTICENTER, RANDOMIZED, OPENLABEL, ACTIVE-CONTROLLED STUDY OF TRASTUZUMAB DERUXTECAN (DS-8201A), AN ANTIHER2-ANTIBODY DRUG CONJUGATE, VERSUS TREATMENT OF INVESTIGATOR'S CHOICE FOR HER2-POSITIVE, UNRESECTABLE AND/OR METASTATIC BREAST CANCER SUBJECTS PREVIOUSLY TREATED WITH T-DM1

DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp

completed

Sept. 06, 2018

Interventional

A Phase 3, multicenter, randomized, open-label, active controlled study

treatment purpose

3

1. Men or women >= 20 years old (Japan), >= 18 years old and the age of majority (other countries)
2. Pathologically documented breast cancer that:
a. is unresectable or metastatic
b. has confirmed HER2 positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory
c. was previously treated with T-DM1
3. Documented radiologic progression (during or after most recent treatment or within 6 mo after completing adjuvant therapy)
4. Subjects must have an adequate tumor sample available for confirmation of HER2 status by Central Laboratory (based on most recent tumor tissue sample). If archived tissue is not available, a fresh biopsy is required.
5. Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 mo after the last dose of DS-8201a for female subjects (4.5 mo for male subjects), 6 mo after the last dose of lapatinib/capecitabine for female subjects (3 mo for male subjects), or 7 mo after the last dose of trastuzumab/capecitabine.
6. Adequate hematopoietic, renal and hepatic functions.

1. Prior participation in an antibody drug conjugate study sponsored by Daiichi Sankyo
2. Prior treatment with capecitabine.
3. Uncontrolled or significant cardiovascular disease
4. Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
5. Active central nervous system (CNS) metastases.

Both

Unresectable/metastatic breast cancer with HER2-positive expression

investigational material(s)
Generic name etc : Trastuzumab deruxtecan
INN of investigational material : trastuzumab deruxtecan
Therapeutic category code : 42- Antineoplastic agents
Dosage and Administration for Investigational material : Intravenous (Once every 3 weeks,5.4mg/kg)

control material(s)
Generic name etc : Trastuzumab + Capecitabine
INN of investigational material : trastuzumab + capecitabine
Therapeutic category code : 42- Antineoplastic agents
Dosage and Administration for Investigational material : Trastuzumab 8 mg/kg IV on the first day of treatment followed by 6 mg/kg every 21 days. Capecitabine 1250 mg/m2 administered orally twice daily on Days 1 to 14 of a 21 days schedule.
Generic name etc : Lapatinib + Capecitabine
INN of investigational material : lapatinib + capecitabine
Therapeutic category code : 42- Antineoplastic agents
Dosage and Administration for Investigational material : Lapatinib 1250 mg administered orally daily on Day 1 to 21 of a 21 days schedule. Capecitabine 1000 mg/m2 administered orally twice daily on Days 1 to 14 of a 21 days schedule.

efficacy
Progression-free survival (PFS) based on blinded independent central review (BICR)
Time from the date of randomization to the earliest date of the first objective documentation of radiographic disease progression via BICR according to modified RECIST version 1.1 or death due to any cause.

safety
efficacy
pharmacokinetics
other
Overall survival, Objective response rate, Duration of response, Clinical benefit rate, PFS based on investigator's assessment

June. 27, 2018