Breast02 Randomize

Home , Lapatinib

TRIAL CARD * See reversesideforkeyenrollment criteria. trastuzumab deruxtecan inotherregions ofworld. [fam-] trastuzumab deruxtecaninUSonly; Receptor 2 (HER2)-Positive Breast Cancer Factor Growth Epidermal Human Pre-treated in [Fam-] Trastuzumab Deruxtecan PP-US-8201a-0059 05/19 DS8201-A-U301 • rateobjective response • Confirmed (ORR) (OS) survival • Overall Key endpoints: secondary review central (BICR) independent (PFS) Progression-free blinded on survival based endpoint: Primary (T-DM1).emtansine unresectable and/or metastatic breast patients cancer previously treated with ado-trastuzumab anti-HER2 conjugatean drug antibody (ADC), treatment versus of investigator’s for HER2-positive, choice 3,A phase multicenter, randomized, active-controlled of open-label, trial [fam-] trastuzumab deruxtecan,* description: Study Study design: Duration of (DoR) response Previously Treated With T-DM1 Treated With Previously Patients With HER2-Positive HER2-Positive With Patients Metastatic Breast Cancer Cancer Breast Metastatic Unresectable and/or

-Breast02 Randomize

2:1 not been established. have efficacy and Safety country. any in indication any for approved been investigational agent has that not [Fam-] trastuzumab deruxtecan is an [Fam-] Trastuzumab Deruxtecan • • Investigator’s include: options choice lapatinib+capecitabine trastuzumab+capecitabine Investigator’s Choice (n ≈400) (n ≈200) Europe, Australia, Asia and ENROLLING SOON in the United States, NOW ENROLLING ENROLLING NOW in South America

-Breast02 [Fam-] Trastuzumab Deruxtecan in Pre-treated Human Epidermal Growth Factor TRIAL CARD TRIAL Receptor 2 (HER2)-Positive Breast Cancer

Key inclusion criteria: 1. Adults ≥18 years old (subject to local regulatory requirements) 2. Documented pathological breast cancer that is unresectable or metastatic, was previously treated with ado-trastuzumab emtansine (T-DM1), and has HER2-positive expression confirmed per protocol 3. Documented radiologic progression (during or after recent treatment or within 6 months after completing adjuvant therapy) 4. At least one measurable lesion per modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1 5. Protocol-defined adequate cardiac, renal, and hepatic function

Key exclusion criteria: 1. Prior treatment with capecitabine or ineligible for comparator arm treatment 2. Uncontrolled or significant cardiovascular disease 3. Medical history of clinically significant interstitial lung disease (ILD)/pneumonitis or is suspected to have ILD/pneumonitis based on imaging at screening period 4. Clinically active central nervous system metastases

Location: Study sites in North and South America, Europe, Australia, and Asia For more information, please visit: https://clinicaltrials.gov/ct2/show/study/NCT03523585. ClinicalTrials.gov identifier:NCT03523585, EUDRA clinical trials identifier:2018-000221-31, Japan clinical trials identifier: JapicCTI-184017.

FOR HEALTHCARE PROFESSIONAL USE ONLY; NOT FOR USE WITH PATIENTS Scan Here

Learn More