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

NCT02658734 | Completed Phase 4 Results

• 1 other identifier: ML29662
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 13

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.

Conditions

HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From cycle 1 up to approximately 3 years

Secondary Outcomes (14)

• Percentage of Participants With Serious Adverse Events (SAEs)

  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

  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 Discontinuation of Study Medication

  From cycle 1 up to approximately 3 years

Study Arms (1)

Trastuzumab emtansine

EXPERIMENTAL

Drug: Trastuzumab emtansine

Interventions

Trastuzumab emtansine DRUG

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

Trastuzumab emtansine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• History of symptomatic chronic heart failure (New York Heart Association \[NYHA\] Classes II-IV) or serious cardiac arrhythmia requiring treatment
• History of myocardial infarction or unstable angina within 6 months of enrollment
• Current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy
• Current severe, uncontrolled systemic disease
• Pregnancy or lactation

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (13)

Apollo Hospitals International Limited

Gandhinagar, Gujarat, 382428, India

Location

Manipal Hospital; Department of Oncology

Bangalore, Karnataka, 560017, India

Location

Tata Memorial Hospital; Dept of Medical Oncology

Mumbai, Maharashtra, 400012, India

Location

Jehangir Hospital

Pune, Maharashtra, 411001, India

Location

Indraprastha Apollo Hospitals

New Delhi, National Capital Territory of Delhi, 110076, India

Location

Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology

New Delhi, National Capital Territory of Delhi, 110085, India

Location

Max Super Speciality Hospital; Medical Oncology

North WEST Delhi, National Capital Territory of Delhi, 110088, India

Location

Christian Medical College & Hospital; Medicine

Vellore, Tamil Nadu, 632004, India

Location

Healthcare Global Enterprises Limited

Bangalore, 560027, India

Location

Artemis Health Institute

Gūrgaon, 122001, India

Location

Fortis Memorial Research Institute; Department of Medical Oncology & Haematology

Gūrgaon, 122002, India

Location

Sir Gangaram Hospital; Medical Oncology

New Delhi, 110 060, India

Location

Max Super Speciality Hospital

New Delhi, 110017, India

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ado-Trastuzumab Emtansine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Maytansine; Macrolides; Lactones; Organic Chemicals; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Trastuzumab; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2016
• First Posted: January 20, 2016
• Study Start: November 1, 2016
• Primary Completion: December 14, 2019
• Study Completion: December 14, 2019
• Last Updated: April 2, 2021
• Results First Posted: February 9, 2021

Record last verified: 2021-03

Locations

IN (13)