This is a Phase IV, single-arm, multicenter, open-label clinical trial designed to assess the safety of trastuzumab emtansine in Indian patients with HER2-positive unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior treatment with trastuzumab and a taxane.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
70
3.6 mg/kg intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle, repeated every 3 weeks
Apollo Hospitals International Limited
Gandhinagar, Gujarat, India
Manipal Hospital; Department of Oncology
Bangalore, Karnataka, India
Tata Memorial Hospital; Dept of Medical Oncology
Mumbai, Maharashtra, India
Jehangir Hospital
Pune, Maharashtra, India
Indraprastha Apollo Hospitals
New Delhi, National Capital Territory of Delhi, India
Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology
New Delhi, National Capital Territory of Delhi, India
Max Super Speciality Hospital; Medical Oncology
North WEST Delhi, National Capital Territory of Delhi, India
Christian Medical College & Hospital; Medicine
Vellore, Tamil Nadu, India
Healthcare Global Enterprises Limited
Bangalore, India
Artemis Health Institute
Gūrgaon, India
...and 3 more locations
Severity of Adverse Events
Adverse events (AEs) grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
Time frame: From cycle 1 up to approximately 3 years
Percentage of Participants With Adverse Events
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with the treatment. An adverse event was therefore any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsened during the study were also considered as adverse events.
Time frame: From cycle 1 up to approximately 3 years
Percentage of Participants With Serious Adverse Events (SAEs)
SAEs were defined as any AE that fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/ birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.
Time frame: From cycle 1 up to approximately 3 years
Severity of SAEs as Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03
Severity refered to the intensity of an AE (e.g., rated as mild, moderate, or severe, or according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria.
Time frame: From cycle 1 up to approximately 3 years
Percentage of Participants With Non-Serious Adverse Events of Special Interest
Non-serious AEs of special interest included cases of severe drug-induced liver injury and suspected transmission of an infectious agent by the study drug.
Time frame: From cycle 1 up to approximately 3 years
Laboratory Results Abnormalities
Time frame: From cycle 1 up to approximately 3 years
Percentage of Participants With Adverse Events Leading to Discontinuation of Study Medication
Time frame: From cycle 1 up to approximately 3 years
Percentage of Participants With Adverse Events Leading to Modification of Study Medication
Time frame: From cycle 1 up to approximately 3 years
Percentage of Participants With Adverse Events Leading to Interruption of Study Medication
Time frame: From cycle 1 up to approximately 3 years
Exposure to Study Drug
Exposure to study drug was the amount of study drug received over time (weeks).
Time frame: From cycle 1 up to approximately 3 years
Percentage of Participants With Drug-Induced Liver Injury Meeting Hy's Law Criteria
Hy's law criteria for potential drug-induced liver injury included elevated aminotransferase enzymes (ALT/AST) with concurrent elevated serum total bilirubin, gross jaundice, clinical disability and the need for hospital care.
Time frame: From cycle 1 up to approximately 3 years
Percentage of Participants With Congestive Heart Failure
Time frame: From cycle 1 up to approximately 3 years
Change in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram
Time frame: From baseline to every three cycles of treatment up to Cycle 39 Day 1, and at the 2-days post-treatment, safety follow-up visits 1 and 3
Overall Response Rate (ORR)
ORR was based on the best (confirmed) overall response (BOR). ORR was defined as the number (%) of participants with confirmed complete response (CR) or partial response (PR) where the confirmation was performed no less than 4 weeks after the criteria for response were first met.
Time frame: From cycle 1 up to approximately 3 years
Progression-Free Survival (PFS)
PFS was defined as the time from the date of enrollment until the date of first documented progression of disease or the date of death (by any cause in the absence of progression) whichever occurred first.
Time frame: From cycle 1 up to approximately 3 years
Overall Survival (OS)
Overall survival was defined as the time from the date of enrollment until the date of death due to any cause. Participants not known to have died at the time of final analysis were censored based on the last recorded date on which the subject was known to be alive.
Time frame: From cycle 1 up to approximately 3 years
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