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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

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ClinicalTrials.gov Identifier: NCT02658734
Recruitment Status : Completed
First Posted : January 20, 2016
Results First Posted : February 9, 2021
Last Update Posted : February 9, 2021
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 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: 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.

  2. 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 Outcome Measures :
  1. Percentage of Participants With Serious Adverse Events (SAEs) [ Time Frame: From cycle 1 up to approximately 3 years ]
    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.

  2. Severity of SAEs as Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 [ Time Frame: From cycle 1 up to approximately 3 years ]
    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.

  3. Percentage of Participants With Non-Serious Adverse Events of Special Interest [ Time Frame: From cycle 1 up to approximately 3 years ]
    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.

  4. Laboratory Results Abnormalities [ Time Frame: From cycle 1 up to approximately 3 years ]
  5. Percentage of Participants With Adverse Events Leading to Discontinuation of Study Medication [ Time Frame: From cycle 1 up to approximately 3 years ]
  6. Percentage of Participants With Adverse Events Leading to Modification of Study Medication [ Time Frame: From cycle 1 up to approximately 3 years ]
  7. Percentage of Participants With Adverse Events Leading to Interruption of Study Medication [ Time Frame: From cycle 1 up to approximately 3 years ]
  8. Exposure to Study Drug [ Time Frame: From cycle 1 up to approximately 3 years ]
    Exposure to study drug was the amount of study drug received over time (weeks).

  9. Percentage of Participants With Drug-Induced Liver Injury Meeting Hy's Law Criteria [ Time Frame: From cycle 1 up to approximately 3 years ]
    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.

  10. Percentage of Participants With Congestive Heart Failure [ Time Frame: From cycle 1 up to approximately 3 years ]
  11. 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 ]
  12. Overall Response Rate (ORR) [ Time Frame: From cycle 1 up to approximately 3 years ]
    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.

  13. Progression-Free Survival (PFS) [ Time Frame: From cycle 1 up to approximately 3 years ]
    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.

  14. Overall Survival (OS) [ Time Frame: From cycle 1 up to approximately 3 years ]
    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.



Information from the National Library of Medicine

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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
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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
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Study Director: Clinical Trials Hoffmann-La Roche
  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:
Study Protocol  [PDF] February 12, 2018
Statistical Analysis Plan  [PDF] May 16, 2018

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02658734    
Other Study ID Numbers: ML29662
First Posted: January 20, 2016    Key Record Dates
Results First Posted: February 9, 2021
Last Update Posted: February 9, 2021
Last Verified: January 2021
Additional relevant MeSH terms:
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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