Unresectable/metastatic breast cancer with HER2-positive expression
Conditions
Sponsors
DAIICHI SANKYO Co.,Ltd.
AstraZeneca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics other Overall survival, Objective response rate, Duration of response, Clinical benefit rate, PFS based on investigator's assessment | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South America
Contacts
Public ContactContact for Clinical Trial Information
DAIICHI SANKYO Co.,Ltd.
Outcome results
None listed