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

Hoffmann-La Roche13 sites in 1 country70 target enrollmentNovember 1, 2016

ConditionsHER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer

InterventionsTrastuzumab emtansine

DrugsTrastuzumab emtansine

Overview

Phase: Phase 4
Intervention: Trastuzumab emtansine
Conditions: HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer
Sponsor: Hoffmann-La Roche
Enrollment: 70
Locations: 13
Primary Endpoint: Severity of Adverse Events
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 1, 2016

End Date

December 14, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Prospectively confirmed HER2-positive (i.e., IHC 3+ or IHC 2+ and gene amplified by fluorescence in situ hybridization \[FISH\] positive) as assessed on primary tumor and/or metastatic site
•Documented progression of unresectable, locally advanced, or mBC, determined by the investigator
•Left ventricular ejection fraction (LVEF) \>/= 50% by echocardiogram (ECHO)
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•A negative serum Beta-Human Chorionic Gonadotropin (Beta-HCG) test for women of childbearing potential (premenopausal or not meeting the definition of postmenopausal i.e. \>/= 12 months of amenorrhea), and women who have not undergone surgical sterilization (i.e., absence of ovaries and/or uterus)
•For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate non-hormonal methods of contraception, including at least one method with a failure rate of \<1% per year, during the treatment period and for at least 7 months after the last dose of study drug
•For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm. With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \<1% per year during the treatment period and for at least 7 months plus 90 days (a spermatogenesis cycle) after the last dose of study drug. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 7 months after the last dose of study drug.

Exclusion Criteria

•Prior treatment with trastuzumab emtansine
•Prior treatment with lapatinib or lapatinib with capecitabine or non-comparable biologic or biosimilar of trastuzumab
•Peripheral neuropathy of Grade \>/= 3 per the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE \[version 4.03\])
•History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer, or cancers with a similar curative outcome as those mentioned above
•History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to enrollment except hormone therapy, which can be given up to 7 days prior to enrollment; recovery of treatment-related toxicity consistent with other eligibility criteria
•History of exposure to cumulative doses of anthracyclines, as defined in the protocol
•History of radiation therapy within 14 days of enrollment
•Brain metastases that are untreated, symptomatic, or require therapy to control symptoms, as well as a history of radiation, surgery, or other therapy, including steroids, to control symptoms from brain metastases within 2 months (60 days) before enrollment
•CNS only disease
•History of a decrease in LVEF to \< 40% or symptomatic congestive heart failure (CHF) with previous trastuzumab treatment

Arms & Interventions

Trastuzumab emtansine

Intervention: Trastuzumab emtansine

Outcomes

Primary Outcomes

Severity of Adverse Events

Time Frame: From cycle 1 up to approximately 3 years

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

Percentage of Participants With Adverse Events

Time Frame: From cycle 1 up to approximately 3 years

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.

Secondary Outcomes

Severity of SAEs as Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03(From cycle 1 up to approximately 3 years)
Percentage of Participants With Adverse Events Leading to Discontinuation of Study Medication(From cycle 1 up to approximately 3 years)
Percentage of Participants With Adverse Events Leading to Interruption of Study Medication(From cycle 1 up to approximately 3 years)
Exposure to Study Drug(From cycle 1 up to approximately 3 years)
Percentage of Participants With Drug-Induced Liver Injury Meeting Hy's Law Criteria(From cycle 1 up to approximately 3 years)
Change in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram(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)(From cycle 1 up to approximately 3 years)
Percentage of Participants With Serious Adverse Events (SAEs)(From cycle 1 up to approximately 3 years)
Percentage of Participants With Non-Serious Adverse Events of Special Interest(From cycle 1 up to approximately 3 years)
Laboratory Results Abnormalities(From cycle 1 up to approximately 3 years)
Percentage of Participants With Adverse Events Leading to Modification of Study Medication(From cycle 1 up to approximately 3 years)
Percentage of Participants With Congestive Heart Failure(From cycle 1 up to approximately 3 years)
Progression-Free Survival (PFS)(From cycle 1 up to approximately 3 years)
Overall Survival (OS)(From cycle 1 up to approximately 3 years)