臨床研究等提出・公開システム

A PHASE 3, MULTICENTER, RANDOMIZED, OPENLABEL, ACTIVE-CONTROLLED STUDY OFTRASTUZUMAB DERUXTECAN (DS-8201A), AN ANTIHER2-ANTIBODY DRUG CONJUGATE (ADC) , VERSUS ADO TRASTUZUMAB EMTANSINE (T-DM1) FOR HER2-POSITIVE, UNRESECTABLE AND/OR METASTATIC BREAST CANCER SUBJECTS PREVIOUSLY TREATED WITH TRASTUZUMAB AND TAXANE

DS-8201a Versus Ado Trastuzumab Emtansine for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]

DAIICHI SANKYO Co.,Ltd.

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

dsclinicaltrial@daiichisankyo.co.jp

DAIICHI SANKYO Co.,Ltd.

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

+81-3-6225-1111

dsclinicaltrial@daiichisankyo.co.jp

completed

Aug. 16, 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 trastuzumab and taxane in the advanced/metastatic setting or progressed within 6 mo after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane
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) or 7 mo after the last dose of T-DM1 for female subjects (4 mo for male subjects).
6. Adequate hematopoietic, renal and hepatic functions.

1. Prior treatment with an anti-HER2 ADC (such as T-DM1) in the metastatic setting. Prior treatment in the adjuvant/neoadjuvant setting would be allowed if progression of disease did not occur within 12 mo of end of adjuvant therapy.
2. Uncontrolled or significant cardiovascular disease
3. 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.
4. 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 emtansine
INN of investigational material : trastuzumab emtansine
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Intravenous (Once every 3 weeks,3.6mg/kg)

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, PFS based on investigator's assessment

June. 27, 2018