Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Daiichi Sankyo Co., Ltd.
With
Daiichi Sankyo
Merck Sharp & Dohme LLC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Is 18 Years and older in the United States or 20 Years and older in Japan
2. Has a pathologically documented advanced/unresectable or metastatic breast cancer
3. Documented HER3-positive disease measured by immunohistochemistry (IHC)
4. Has disease that is refractory to or intolerable with standard treatment, or for which standard treatment no longer is available
5. Has an Eastern Cooperative Oncology Group Performance Status 0-1
6. Has Left Ventricular Ejection Fraction ≥ 50%
7. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
9. Is able to submit a fresh tumor biopsy sample prior to starting study treatment if not already submitted for HER3 expression
11. Has documented hormone (estrogen and progesterone) receptor (HR)-negative and HER2 negative expression according to American Society of Clinical Oncology - College of American Pathologists (ASCO-CAP) guidelines
12. Has progressed after receiving 1 to 2 prior chemotherapy regimens for advanced/unresectable or metastatic breast cancer.
You may not be if
1. Prior treatment with a HER3 antibody
2. Prior treatment with an antibody-drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, DS-8201)
3. Has a medical history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or serious cardiac arrhythmia requiring treatment
4. Has a medical history of myocardial infarction or unstable angina
5. Has a corrected QT prolongation to \> 450 millisecond (ms) in males and \> 470 ms in females
6. Has a medical history of clinically significant lung diseases (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, and radiation pneumonitis) or who are suspected to have these diseases by imaging at screening period
7. Has clinically significant corneal disease
8. Prior treatment with an govitecan derivative (eg, IMMU-132).
Clareo Health | Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer
