Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02658734
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : October 29, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer Drug: Trastuzumab emtansine Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : November 1, 2016
Actual Primary Completion Date : December 14, 2019
Actual Study Completion Date : December 14, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Trastuzumab emtansine Drug: Trastuzumab emtansine
3.6 mg/kg intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle, repeated every 3 weeks




Primary Outcome Measures :
  1. Severity of Adverse Events [ Time Frame: Up to approximately 3 years ]
  2. Percentage of Participants With Adverse Events [ Time Frame: Up to approximately 3 years ]

Secondary Outcome Measures :
  1. Percentage of Participants With Serious Adverse Events (SAEs) [ Time Frame: Up to approximately 3 years ]
  2. Severity of SAEs as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 [ Time Frame: Up to approximately 3 years ]
  3. Percentage of Participants With Non-Serious Adverse Events of Special Interest [ Time Frame: Up to approximately 3 years ]
  4. Laboratory Results Abnormalities [ Time Frame: Up to approximately 3 years ]
  5. Percentage of Participants With Adverse Events Leading to Discontinuation of Study Medication [ Time Frame: Up to approximately 3 years ]
  6. Percentage of Participants With Adverse Events Leading to Modification of Study Medication [ Time Frame: Up to approximately 3 years ]
  7. Percentage of Participants With Adverse Events Leading to Interruption of Study Medication [ Time Frame: Up to approximately 3 years ]
  8. Exposure to Study Medication, as Measured by the Area Under the Concentration-Time Curve (AUC) [ Time Frame: Up to approximately 3 years ]
  9. Percentage of Participants With Drug-Induced Liver Injury Meeting Hy's Law Criteria [ Time Frame: Up to approximately 3 years ]
  10. Percentage of Participants With Congestive Heart Failure [ Time Frame: Up to approximately 3 years ]
  11. Left Ventricular Ejection Fraction (LVEF) Decrease as Measured by Echocardiogram [ Time Frame: Up to approximately 3 years ]
  12. Overall Response Rate (ORR) [ Time Frame: Up to approximately 3 years ]
  13. Progression-Free Survival (PFS) [ Time Frame: Up to approximately 3 years ]
  14. Overall Survival (OS) [ Time Frame: Up to approximately 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
  • Concurrent, serious, uncontrolled infections or current known infection with human immunodeficiency virus (HIV) or active hepatitis B and/or hepatitis C. For patients who are known carriers of hepatitis B virus (HBV), active hepatitis B infection must be ruled out, based on negative serologic testing and/or determination of HBV DNA viral load per local guidelines
  • Presence of conditions that could affect gastrointestinal absorption: malabsorption syndrome, resection of the small bowel or stomach, and ulcerative colitis
  • History of intolerance (such as Grade 3-4 infusion reaction) or known hypersensitivity to trastuzumab or murine proteins or any component of the product
  • Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658734


Locations
Layout table for location information
India
Indraprastha Apollo Hospitals
New Delhi, Delhi, India, 110076
Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology
New Delhi, Delhi, India, 110085
Max Super Speciality Hospital; Medical Oncology
North WEST Delhi, Delhi, India, 110088
Apollo Hospitals International Limited
Gandhinagar, Gujarat, India, 382428
Manipal Hospital; Department of Oncology
Bangalore, Karnataka, India, 560017
Tata Memorial Hospital; Dept of Medical Oncology
Mumbai, Maharashtra, India, 400012
Jehangir Hospital
Pune, Maharashtra, India, 411001
Christian Medical College & Hospital; Medicine
Vellore, Tamil NADU, India, 632004
Healthcare Global Enterprises Limited
Bangalore, India, 560027
Artemis Health Institute
Gurgaon, India, 122001
Fortis Memorial Research Institute; Department of Medical Oncology & Haematology
Gurgaon, India, 122002
Sir Gangaram Hospital; Medical Oncology
New Delhi, India, 110 060
Max Super Speciality Hospital
New Delhi, India, 110017
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02658734    
Other Study ID Numbers: ML29662
2008-005713-22 ( EudraCT Number )
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: October 29, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Ado-trastuzumab emtansine
Maytansine
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action