Advanced or Metastatic Breast Cancer
Conditions
Interventions
Trastuzumab deruxtecan (T-DXd
DS-8201a) arm
- Trastuzumab deruxtecan by intravenous infusion
Investigator's choice standard of care chemotherapy (capecitabine, paclitaxel, nab-paclitaxel) arm
- Investigator's choice standard of c
capecitabine tablets will be given orally.
- Investigator's choice standard of care single agent chemotherapy
paclitaxel by intravenous infusion.
- Investigator's choice standard of care single agent chemotherapy
nab-paclitaxel by intravenous infusion
Sponsors
Inoguchi Akihiro
AstraZeneca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients must be >=18 years of age - Pathologically documented breast cancer that: 1.is advanced or metastatic 2.has a history of HER2-low or negative expression by local test, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or HER2 IHC 0 (ISH- or untested) 3.has HER2-low or HER2 IHC >0 =2 lines of previous ET requirement: disease recurrence while on the first 24 months of starting adjuvant ET, will be considered a line of therapy; these patients will only require 1 line of ET in the metastatic setting. - Has protocol-defined adequate organ and bone marrow function
Exclusion criteria
Exclusion criteria: - Ineligible for all options in the investigator's choice chemotherapy arm - Lung-specific intercurrent clinically significant illnesses - Uncontrolled or significant cardiovascular disease or infection - Prior documented interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. - Patients with spinal cord compression or clinically active central nervous system metastases - Prior randomization or treatment in a previous trastuzumab deruxtecan study regardless of treatment arm assignment - Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study during the follow up period of a prior interventional study (prescreening for this study while a patient is on treatment in another clinical study is acceptable)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2 (HER2)-Low Population [Time Frame: Response evaluations performed at screening, every 6 weeks (q6w) +/- 1 week from randomization for 48 weeks, and then every 9 weeks (q9w) +/- 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall Survival (OS) in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low Population [Time Frame: From date of randomization until death due to any cause, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)] 2. Progression-Free Survival Assessed by Blinded Independent Central Review in the Intent-to-Treat, Human Epidermal Growth Factor Receptor 2 Immunohistochemistry (IHC) >0 0 <1+ Population [Time Frame: Response evaluations performed at screening, q6w +/- 1 week from randomization for 48 weeks, and then q9w +/- 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)] 8. Duration of Response Assessed by Blinded Independent Central Review and Investigator in the Intent-to-Treat Population [Time Frame: Response evaluations performed at screening, q6w +/- 1 week from randomization for 48 weeks, and then q9w +/- 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)] 9. Time From Randomization to Second Progression or Death (PFS2) in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low and Intent-to-Treat Population [Time Frame: Response evaluations performed at screening, q6w +/- 1 week from randomization for 48 weeks, and then q9w +/- 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)] 10. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [Time Frame: From first dose of study drug (Day 1) up to PCD of 18 March 2024 (maximum of approximately 43.85 months)] 11. Serum Concentration of Trastuzumab Deruxtecan (T-DXd), Total Anti-Human Epidermal Growth Factor Receptor 2 Antibody and MAAA-1181a [Time Frame: Pre-dose on Day 1 of Cycles 1, 2, 4, 6 and 8; 15 minutes post-dose on Day 1 of Cycles 1, 2 and 4; and 5 hours post-dose on Day 1 of Cycle 1 (each cycle is 21 days)] 12. Chan | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Denmark, France, Germany, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Contacts
Public ContactContact for Clinical Trial Information
DAIICHI SANKYO Co.,Ltd.
Outcome results
None listed