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Study of T-DXd in Patients With Unresectable/Metastatic BC Previously Treated With Standard of Care

Study of T-DXd in Patients With Unresectable/Metastatic BC Previously Treated With Standard of Care1

DESTINY-Breast02 is a randomized, open-label, multicenter, Phase III clinical trial evaluating the efficacy and safety of T-DXd versus TPC in patients with centrally confirmed HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable, and/or metastatic BC previously treated with T-DM1. A total of 608 patients with HER2-positive metastatic BC were randomly assigned 2:1 to receive T-DXd 5.4 mg/kg (n=406) IV Q3W or TPC per label (n=202).1

Study Design.1

Study Design.1

aPatients with clinically inactive brain metastases and patients with treated brain metastases that were no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants could be included; bBICR assessed per mRECIST 1.1;
cPFS2 was defined as the time from date of randomization to the first documented progression on the next line of therapy or death due to any cause, whichever came first; dDuration of follow up is defined as study duration = the date last known alive minus date of randomization plus 1.

Key Eligibility Criteria

Key Eligibility Criteria1,2

Key Eligibility Criteria in DESTINY-Breast02.1,2
Key Inclusion CriteriaKey Exclusion Criteria

Age ≥18 years (subject to local regulatory requirements)

Previous treatment with capecitabine, contraindication for capecitabine or for both trastuzumab and lapatinib

Pathologically documented breast cancer that is unresectable or metastatic, has central laboratory confirmed HER2-positive expressiona as per ASCO/CAP guidelines, and was previously treated with T-DM1

Uncontrolled or significant cardiovascular disease

Documented radiologic progression of diseaseb

Medical history of (noninfectious) ILD/pneumonitis that required steroids or active or suspected ILD/pneumonitis

Protocol-defined adequate hematopoietic, renal, and hepatic function

Clinically active CNS metastases that are untreated and symptomatic, or require therapy to control symptoms

aIf archived tissue is not available, patient agrees to provide a fresh biopsy; bDuring or after most recent treatment or within 6 months after completing adjuvant therapy.

Abbreviations

ASCO/CAP = American Society of Clinical Oncology/College of American Pathologists

;

BC = breast cancer

;

BICR = blinded independent central review

;

CBR = clinical benefit rate

;

CNS = central nervous system

;

DoR = duration of response

;

HER2 = human epidermal growth factor receptor 2

;

IHC = immunohistochemistry

;

ILD = interstitial lung disease

;

ISH = in-situ hybridization

;

IV = intravenous

;

mRECIST = modified Response Evaluation Criteria in Solid Tumors

;

ORR = objective response rate

;

OS = overall survival 

;

PFS = progression-free survival 

;

PFS2 = progression-free survival after subsequent anticancer therapy

;

Q3W = every 3 weeks

;

R = randomization

;

T-DM1 = trastuzumab emtansine

;

T-DXd = trastuzumab deruxtecan

;

TPC = treatment of physician's choice

References

1. Krop IE, Park YH, Kim S-B, et al. Trastuzumab deruxtecan vs physician’s choice treatment in patients with HER2+ unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine: results from the randomized, phase 3 DESTINY Breast02 trial. Presentation presented at: San Antonio Breast Cancer Symposium 2022; December 6-10, 2022; San Antonio, TX. Presentation GS2-01.
2. Daiichi Sankyo, Inc. DS-8201a in pre-treated HER2 breast cancer that cannot be surgically removed or has spread [DESTINY-Breast02]. ClinicalTrials.gov website. https://www.clinicaltrials.gov/ct2/show/NCT03523585

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