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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• Breast Neoplasms 12,544

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 70 is close to the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Study arms

• Experimental
  Trastuzumab emtansine

  Drug: Trastuzumab emtansine

Interventions

• DrugTrastuzumab emtansine

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

Primary outcomes

1. 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.

   Time frame: From cycle 1 up to approximately 3 years

2. 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.

   Time frame: From cycle 1 up to approximately 3 years

Secondary outcomes

1. Percentage of Participants With Serious Adverse Events (SAEs)

   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.

   Time frame: From cycle 1 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

   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.

   Time frame: From cycle 1 up to approximately 3 years

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

   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.

   Time frame: From cycle 1 up to approximately 3 years

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

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

   Time frame: From cycle 1 up to approximately 3 years

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

   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.

   Time frame: From cycle 1 up to approximately 3 years

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)

    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.

    Time frame: From cycle 1 up to approximately 3 years

13. Progression-Free Survival (PFS)

    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.

    Time frame: From cycle 1 up to approximately 3 years

14. Overall Survival (OS)

    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.

    Time frame: From cycle 1 up to approximately 3 years

Baseline characteristics

Study documents

• Study protocol · Feb 12, 2018
• Statistical analysis plan · May 16, 2018

Documents are hosted by the registry — open the source record to download them.