A Phase 3, multicenter, randomized, open-label, active-controlled trial of DS-8201a, an anti-HER2-antibody drug conjugate (ADC), versus treatment of physician's choice for HER2-low, unresectable and/or metastatic breast cancer subjects
Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]
DAIICHI SANKYO Co.,Ltd.
1-2-58, Hiromachi, Shinagawa-ku, Tokyo
+81-3-6225-1111
dsclinicaltrial@daiichisankyo.co.jp
DAIICHI SANKYO Co.,Ltd.
1-2-58, Hiromachi, Shinagawa-ku, Tokyo
+81-3-6225-1111
dsclinicaltrial@daiichisankyo.co.jp
completed
Nov. 29, 2018
540
Interventional
A Phase 3, multicenter, randomized, open-label, active controlled study
treatment purpose
3
1. Men or women >=20 years old (Japan).
2. Has pathologically documented breast cancer that:
a. Is unresectable or metastatic
b. Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)
c. Is HR-positive or HR-negative
d. Has progressed on, and would no longer benefit from, endocrine therapy
e. Has been treated with 1 to 2 prior lines of chemotherapy/adjuvant in the metastatic setting
3. Has documented radiologic progression (during or after most recent treatment)
4. Has adequate tumor samples available or is willing to provide fresh biopsies prior to randomization for:
a. assessment of HER2 status
b. assessment of post-treatment status
5. Has Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
6. Has at least 1 protocol-defined measurable lesion
7. Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions
8. If of reproductive/childbearing potential, agrees to follow instructions for method(s) of contraception and agrees to avoid preserving ova or sperm for at least 4.5 months for male subjects or 7 months for female subjects after treatment
1. Is ineligible for all options in the physician's choice arm
2. Has breast cancer ever assessed with high-HER2 expression
3. Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate
4. Has uncontrolled or significant cardiovascular disease
5. Has spinal cord compression or clinically active central nervous system metastases
6. Has history, current, or suspicion of interstitial lung disease/pneumonitis
7. Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study
20age old over
No limit
Both
Unresectable/metastatic breast cancer with HER2-low expression
investigational material(s)
Generic name etc : DS-8201a
INN of investigational material : trastuzumab deruxtecan
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Intravenous (Once every 3 weeks, 5.4mg/kg)
control material(s)
Generic name etc : Choose one of the following treatment. Capecitabine / Eribulin / Gemcitabine / Paclitaxel / Nab-paclitaxel
INN of investigational material : Capecitabine / Eribulin / Gemcitabine / Paclitaxel / Nab-paclitaxel
Therapeutic category code : 42- Antineoplastic agents
Dosage and Administration for Investigational material : Dosage, regimen, and dose modification in locally approved label and/or local guideline should be used.
efficacy
confirmatory
Progression-free survival (PFS) based on blinded independent central review (BICR)
PFS based on BICR is defined as the time from randomization to the first objective (radiographic) documentation of disease progression or death.
safety
efficacy
confirmatory
PFS based on investigator's assessment, Overall survival, Objective response rate, Duration of response
- PFS based on Investigator Assessment is defined as the time from randomization to the first clinical observation of disease progression or death.
- OS is defined as the time from randomization to death.
- ORR is defined as the percentage of participants who achieved objective CR or PR, confirmed by a second assessment.
- DoR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death
DAIICHI SANKYO CO., LTD.
AstraZeneca
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Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital Institutional Review Board
7-33 Motomachi, Naka-ku, Hiroshima-shi, Hiroshima-ken Japan
