Description:
This study will compare DS 8201a to standard treatment.
Participants must have HER2 breast cancer that has been treated before.
Their cancer:
- cannot be removed by an operation
- has spread to other parts of the body
Title
- Brief Title: DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]
- Official Title: A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1
Clinical Trial IDs
- ORG STUDY ID:
DS8201-A-U301
- SECONDARY ID:
2018-000221-31
- SECONDARY ID:
184017
- SECONDARY ID:
DESTINY-B02
- NCT ID:
NCT03523585
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Trastuzumab deruxtecan | DS-8201a | Trastuzumab deruxtecan (DS-8201a) |
Capecitabine | Investigator's Choice Comparative Therapy | Lapatinib+capecitabine |
Lapatinib | Investigator's Choice Comparative Therapy | Lapatinib+capecitabine |
Trastuzumab | Investigator's Choice Comparative Therapy | Trastuzumab+capecitabine |
Purpose
This study will compare DS 8201a to standard treatment.
Participants must have HER2 breast cancer that has been treated before.
Their cancer:
- cannot be removed by an operation
- has spread to other parts of the body
Detailed Description
The study is designed to compare DS 8201a versus standard of care (investigator's choice) in
subjects with unresectable and/or metastatic breast cancer previously treated with T-DM1.
Trial Arms
Name | Type | Description | Interventions |
---|
Trastuzumab deruxtecan (DS-8201a) | Experimental | HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to treatment with DS-8201a | |
Trastuzumab+capecitabine | Active Comparator | HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Trastuzumab/capecitabine | |
Lapatinib+capecitabine | Active Comparator | HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Lapatinib/capecitabine | |
Eligibility Criteria
Inclusion Criteria:
- Is the age of majority in their country
- Has pathologically documented breast cancer that:
1. is unresectable or metastatic
2. has confirmed HER2-positive expression as determined according to American
Society of Clinical Oncology - College of American Pathologists guidelines
evaluated at a central laboratory
3. was previously treated with ado-trastuzumab emtansine (T-DM1)
- Has documented radiologic progression (during or after most recent treatment or within
6 months after completing adjuvant therapy)
- Is HER2 positive as confirmed by central laboratory assessment of most recent tumor
tissue sample available. If archived tissue is not available, agrees to provide a
fresh biopsy.
- Male and female participants 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:
1. 7 months after the last dose of DS-8201a (females); 4.5 months after last dose of
DS-8201a (males)
2. 6 months after the last dose of lapatinib/capecitabine for female participants (3
months for male participants)
3. 7 months after the last dose of trastuzumab/capecitabine
- Has adequate hematopoietic, renal and hepatic functions
Exclusion Criteria:
- Has previously participated in an antibody drug conjugate study sponsored by Daiichi
Sankyo. Prior treatment in the adjuvant/neo-adjuvant setting would be allowed if
progression of disease did not occur within 12 months of end of adjuvant therapy
- Has had prior treatment with capecitabine
- Has uncontrolled or significant cardiovascular disease
- Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that
required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that
cannot be ruled out by imaging at screening
- Has active central nervous system (CNS) metastases
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression-free survival (PFS) based on blinded independent central review (BICR) |
Time Frame: | Baseline up to 42 months postdose |
Safety Issue: | |
Description: | Time from the date of randomization to the first objective documentation of radiographic disease progression via BICR according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1, or death due to any cause. |
Secondary Outcome Measures
Measure: | Overall survival (OS) |
Time Frame: | Baseline up to 78 months postdose |
Safety Issue: | |
Description: | Time from the date of randomization to the date of death for any cause. If there is no death reported for a subject before the data cutoff for OS analysis, OS will be censored at the last contact date at which the subject is known to be alive. |
Measure: | Objective response rate (ORR) based on BICR and investigator assessment |
Time Frame: | Baseline up to 78 months postdose |
Safety Issue: | |
Description: | Percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR), based on BICR and investigator assessment |
Measure: | Duration of response (DoR) based on BICR and investigator's assessment |
Time Frame: | Baseline up to 78 months postdose |
Safety Issue: | |
Description: | Length of time response continued, based on BICR and investigator's assessment |
Measure: | Progression-free survival (PFS) based on investigator's assessment |
Time Frame: | Baseline up to 42 months postdose |
Safety Issue: | |
Description: | Time from the date of randomization to the first objective documentation of radiographic disease progression via investigator assessment, according to mRECIST version 1.1, or death due to any cause. |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Daiichi Sankyo, Inc. |
Trial Keywords
- Breast Cancer
- Metastatic breast cancer
- DS 8201a
- DESTINY - Breast 02
Last Updated
January 8, 2021