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Trustees of The University of Pennsylvania | Abramson Cancer Center

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

Daiichi Sankyo logo

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:

    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

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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