Testing a new targeted therapy trastuzumab deruxtecan(DS-8201a), against other targeted and chemotherapy (selected by your doctor) for patients with advanced-stage breast cancer.
- Conditions
- nresectable/metastatic breast cancer with human epidermal growth factor receptor 2 (HER2)-positive expressionMedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-000221-31-GR
- Lead Sponsor
- Daiichi Sankyo Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 608
• Adults =18 years old. (Please follow local regulatory requirements if
the legal age of consent for study participation is >18 y old.)
• 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 T DM1.
• Documented radiologic progression (during or after most recent
treatment or within 6 mo after completing adjuvant therapy).
• Subjects must be HER2 positive as confirmed by central laboratory
assessment of most recent tumor tissue sample available.
• Female subjects 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 mo after the last
dose of trastuzumab deruxtecan, 6 mo after the last dose of
lapatinib/capecitabine, or 7 mo after the last dose of
trastuzumab/capecitabine. Male subjects must agree to inform all
potential female partners that they are participating in a clinical trial of a
drug that may cause birth defects. Male subjects must also agree to
either avoid intercourse or that he and/or any female partner of
reproductive/childbearing potential will use a highly effective form of
contraception during and upon completion of the study and for at least
4.5 mo after the last dose of trastuzumab deruxtecan, 3 mo after the last
dose of lapatinib/capecitabine, or 7 mo after the last dose of
trastuzumab/capecitabine.
• Adequate renal function, defined as:
- Creatinine clearance = 30 mL/min, as calculated using the Cockcroft-
Gault equation,
• Adequate hepatic function, defined as:
- Total bilirubin = 1.5 × upper limit of normal (ULN) if no liver
metastases or < 3 × ULN in the presence of documented Gilbert's
Syndrome (unconjugated hyperbilirubinemia) or liver metastases at
baseline
and
- Aspartate transaminase/alanine transaminase = 5 × ULN
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 342
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 258
• Ineligible for the comparator arm treatment for reasons including but
not limited to the following:
- Prior treatment with capecitabine.
- History of any contraindication included in the approved local label for
capecitabine or for both trastuzumab and lapatinib;
- Concurrent treatment with any medication prohibited in the applicable
approved local label for capecitabine or for both trastuzumab and
lapatinib.
• Prior participation in a study involving an antibody drug conjugate
produced by Daiichi Sankyo.
• Uncontrolled or significant cardiovascular disease, including any of the
following:
- History of myocardial infarction within 6 mo before randomization
- History of symptomatic congestive heart failure (New York Heart
Association Class II to IV)
- Troponin levels consistent with myocardial infarction as defined
according to the manufacturer within 28 d prior to randomization
- Corrected QT interval prolongation to >470 ms (females) or >450 ms
(male) based on average of screening triplicate 12 lead
electrocardiogram (ECG)
- Left ventricular ejection fraction (LVEF) < 50% within 28 d prior to
randomization
• Has a history of (noninfectious) interstitial lung disease
(ILD)/pneumonitis that required steroids, has current ILD/pneumonitis,
or where suspected ILD/pneumonitis cannot be ruled out by imaging at
screening.
• Spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated or symptomatic, or requiring
therapy with corticosteroids or anticonvulsants to control associated
symptoms.
- Subjects with clinically inactive brain metastases may be included in
the study.
- Subjects with treated brain metastases that are no longer
symptomatic and who require no treatment with corticosteroids or
anticonvulsants may be included in the study if they have recovered
from the acute toxic effect of radiotherapy. A minimum of 2 weeks must
have elapsed between the end of whole brain radiotherapy and study
enrollment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method