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

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Daiichi Sankyo

Status and phase

Active, not recruiting
Phase 3

Conditions

Breast Cancer

Treatments

Drug: Trastuzumab
Drug: Trastuzumab deruxtecan
Drug: Capecitabine
Drug: Lapatinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT03523585
2018-000221-31 (EudraCT Number)
184017 (Registry Identifier)
DESTINY-Breast02 (Other Identifier)
DS8201-A-U301

Details and patient eligibility

About

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

Full 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.

Enrollment

608 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Is the age of majority in their country

Has pathologically documented breast cancer that:

  • is unresectable or metastatic
  • has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory
  • 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:

  • 7 months after the last dose of DS-8201a (females); 4.5 months after last dose of DS-8201a (males)
  • 6 months after the last dose of lapatinib/capecitabine for female participants (3 months for male participants)
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

608 participants in 3 patient groups

Trastuzumab deruxtecan (DS-8201a)
Experimental group
Description:
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
Treatment:
Drug: Trastuzumab deruxtecan
Trastuzumab+capecitabine
Active Comparator group
Description:
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
Treatment:
Drug: Capecitabine
Drug: Trastuzumab
Lapatinib+capecitabine
Active Comparator group
Description:
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
Treatment:
Drug: Lapatinib
Drug: Capecitabine

Trial documents
1

Trial contacts and locations

227

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Data sourced from clinicaltrials.gov

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