Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Arrhythmia Agents

Vasodilator Agents

Analgesics

Ado-Trastuzumab Emtansine

Trastuzumab

Mitogens

Taxane

Adenosine

Maytansine

Antineoplastic Agents, Immunological

Tubulin Modulators

Antimitotic Agents

Immunotoxins

Immunoconjugates

Immunologic Factors

3.6 mg/kg intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle, repeated every 3 weeks

Trastuzumab emtansine

Clinical Trials

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.

A Study of Trastuzumab Emtansine in Indian Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Treatment With Trastuzumab and a Taxane

A Multicenter, Open-Label, Single-Arm, Phase IV Study of Trastuzumab Emtansine in Indian Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Treatment With Trastuzumab and a Taxane

Adverse events (AEs) grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.

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.

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.

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.

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.

Exposure to study drug was the amount of study drug received over time (weeks).

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.

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.

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.

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.

Hoffmann-La Roche

3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.

Trastuzumab Emtansine

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Intent-to-treat (ITT) population included all participants enrolled in the study.

Medical Communications

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

Safety Population included all enrolled participants who received at least one dose of study medication.

Severity of Adverse Events

Percentage of Participants With Adverse Events

Percentage of Participants With Serious Adverse Events (SAEs)

Severity of SAEs as Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03

Percentage of Participants With Non-Serious Adverse Events of Special Interest

Basophils - High

Basophils/Leukocytes - Low

Basophils/Leukocytes - High

Monocytes - High

Hematocrit - Low

Hematocrit - High

Lymphocytes/Leukocytes - Low

Lymphocytes/Leukocytes - High

Monocytes/Leukocytes - Low

Monocytes/Leukocytes - High

Neutrophils/Leukocytes - Low

Neutrophils/Leukocytes - High

Other Cells - High

Other Cells/Leukocytes - High

Erythrocytes - Low

Erythrocytes - High

Eosinophils/Leukocytes - Low

Eosinophils/Leukocytes - High

Bilirubin - Low

Bilirubin - High

Bicarbonate - Low

Bicarbonate - High

Direct Bilirubin - High

Blood Urea Nitrogen - Low

Blood Urea Nitrogen - High

Chloride - Low

Chloride - High

Lactate Dehydrogenase - Low

Lactate Dehydrogenase - High

Protein - Low

Protein - High

Urea - Low

Urea - High

Partial Thromboplastin Time - Low

Partial Thromboplastin Time - High

Laboratory Results Abnormalities

Percentage of Participants With Adverse Events Leading to Discontinuation of Study Medication

Dose Reduced

Drug Interrupted

Percentage of Participants With Adverse Events Leading to Modification of Study Medication

Percentage of Participants With Adverse Events Leading to Interruption of Study Medication

Exposure to Study Drug

Percentage of Participants With Drug-Induced Liver Injury Meeting Hy's Law Criteria

Percentage of Participants With Congestive Heart Failure

Baseline

Cycle 03 Day 1

Cycle 06 Day 1

Cycle 09 Day 1

Cycle 12 Day 1

Cycle 15 Day 1

Cycle 18 Day 1

Cycle 21 Day 1

Cycle 24 Day 1

Cycle 27 Day 1

Cycle 30 Day 1

Cycle 33 Day 1

Cycle 36 Day 1

Cycle 39 Day 1

Safety Follow-Up 1

Safety Follow-Up 3

Change in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram

Spots Global Cancer Trial Database for A Study of Trastuzumab Emtansine in Indian Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Treatment With Trastuzumab and a Taxane

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial