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Active Clinical Trials

DS-8201a Versus Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Pretreated With Prior Standard of Care [DESTINY-Breast02]

Active NCT:
03523585
Allegheny General Hospital
Allegheny General Hospital

Forbes Hospital
Forbes Hospital

Category:
Cancer - Breast
Sponsor: 
Daiichi Sankyo, Inc.
Contact: 

For more information, please contact Dawn Kolar by telephone at 412-359-8162 or Dawn.Kolar@ahn.org or Ashley Young by telephone at 412-359-6458 or Ashley.Young@ahn.org.

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study Of DS 8201a, An Anti-HER2-Antibody Drug Conjugate, Versus Treatment Of Investigator’s Choice For HER2-Positive, Unresectable And/Or Metastatic Breast Cancer Subjects Pretreated With Prior Standard Of Care HER2 Therapies, Including T-DM1

Purpose: 

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.

Ages Eligible for Study:  18 Years and older   (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

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:

4.5 months after the last dose of DS-8201a

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

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