Spots Global Cancer Trial Database for Phase II Study of Herzuma® Plus Gedatolisib in Patients With HER-2 Positive Metastatic Breast Cancer
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Trial Identification
Brief Title: Phase II Study of Herzuma® Plus Gedatolisib in Patients With HER-2 Positive Metastatic Breast Cancer
Official Title: Phase II Study of Trastuzumab Biosimilar (Herzuma®) Plus Gedatolisib in Patients With HER-2 Positive Metastatic Breast Cancer Who Progressed After 2 or More HER-2 Directed Chemotherapy
Study ID: NCT03698383
Interventions
Study Description
Brief Summary: Phase II Pilot Study of Trastuzumab Biosimilar (Herzuma®) plus Gedatolisib in Patients with HER-2 Positive Metastatic Breast Cancer Who Progressed after 2 or more HER-2 directed Chemotherapy
Detailed Description: All the patients will be included in the final analysis, with a total of 15 patients to be enrolled. Treatment will occur until disease progression, unacceptable toxicity or patient withdrawal. Tumor measurement and evaluation are going to be performed at every 6 weeks for the first 3 months, then at every 9 weeks till progression, and then follow-up evaluation at every 12 weeks thereafter end of study.
Keywords
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Samsung Medical Center, Seoul, , Korea, Republic of
Contact Details
Name: Kyong Hwa Park, MD, PhD
Affiliation: Korean Cancer Study Group
Role: PRINCIPAL_INVESTIGATOR
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