DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]

• Status: Active, not recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo, Inc.
• Collaborators: AstraZeneca; Daiichi Sankyo Co., Ltd.
• Treatments: Ado-trastuzumab emtansine; Camptothecin; Capecitabine; Immunoconjugates; Lapatinib; Trastuzumab

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