Health Condition 1: null- Breast Cancer
Conditions
Interventions
Intervention1: Trastuzumab Emtansine: Patients will receive intravenous (IV) trastuzumab emtansine 3.6 mg/kg over 30â??90 minutes on Day 1 of a 21-day cycle. Patients will receive treatment until dise
Sponsors
Roche Products India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female of age >= 18 years 2. 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 if primary tumor not available (ISH positivity is defined as a ratio of 2.0 or greater for the number of HER2 gene copies to the number of signals for CEP17, or for single probe tests, a HER2 gene count greater than 4) as determined in a local laboratory that is experienced/certified in HER2-expression testing using an accurate and validated assay 3. Histologically or cytologically documented invasive breast cancer: unresectable, LABC or mBC 4. Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced, or metastatic setting must include:- i. A taxane, alone or in combination with another agent, AND ii. Trastuzumab, alone or in combination with another agent in the adjuvant, unresectable, locally advanced, or metastatic setting 5. Documented progression of unresectable, locally advanced, or mBC, determined by the investigator; progression must occur during or after most recent treatment for LABC/mBC or within 6 months after completing adjuvant therapy 6. Measurable and/or non-measurable disease 7. LVEF >= 50% by echocardiogram (ECHO) 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 9. Adequate organ function, evidenced by the following laboratory results within 30 days of enrollment: i. Absolute neutrophil count > 1,500 cells/mm3 ii. Platelet count > 100,000 cells/mm3 iii. Hemoglobin > 9.0 g/dL. Patients will be allowed to be transfused red blood cells to this level iv. Albumin >= 2.5 g/dL v. Total bilirubin vi. Serum glutamic oxaloacetic transaminase (SGOT) or aspartate aminotransferase (AST), serum glutamic pyruvic transaminase (SGPT) or alanine aminotransferase (ALT), and alkaline phosphatase (ALP) vii. Creatinine clearance > 50 mL/min based on Cockroft-Gault glomerular filtration rate estimation: (140 â?? Age) Ã? (weight in kg) Ã? (0.85 if female)/(72 Ã? serum creatinine) viii. International normalized ratio (INR) and activated partial thromboplastin time (aPTT) 10. A negative serum β-Human Chorinic Gonadotropin (β-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) within 7 days prior to the first dose of study treatment with the result available prior to first dosing 11. 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 ï?¼ 1% per year, during the treatment period and for at least 7 months after the last dose of study drug A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (ï?³ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal
Exclusion criteria
Exclusion criteria: 1. Prior treatment with trastuzumab emtansine 2. Prior treatment with lapatinib or lapatinib with capecitabine or non-comparable biologic or biosimilar of trastuzumab 3. Peripheral neuropathy of Grade >= 3 per NCI CTCAE (version 4.03) 4. 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 5. 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 6. History of exposure to the following cumulative doses of anthracyclines: i. Doxorubicin or liposomal doxorubicin > 500 mg/m2 ii. Epirubicin > 900 mg/m2 iii. Mitoxantrone > 120 mg/m2 iv. If another anthracycline, or more than one anthracycline, has been used, the cumulative dose must not exceed the equivalent of 500 mg/m2 doxorubicin 7. History of radiation therapy within 14 days of enrollment. The patient must have recovered from any resulting acute toxicity (to Grade 8. 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 9. History of a decrease in LVEF to 10. History of symptomatic chronic heart failure (New York Heart Association [NYHA] Classes IIâ??IV) or serious cardiac arrhythmia requiring treatment 11. History of myocardial infarction or unstable angina within 6 months of enrollment 12. Current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy 13. Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease) 14. Pregnancy or lactation 15. 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 16. Presence of conditions that could affect gastrointestinal absorption: malabsorption syndrome, resection of the small bowel or stomach, and ulcerative colitis 17. History of intolerance (such as Grade 3-4 infusion reaction) or known hypersensitivity to trastuzumab or murine proteins or any component of the product 18. Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measures for this study are on safety evaluationTimepoint: â?¢ Incidence and severity of AEs and SAEs as per NCI-CTCAE (version 4.03) â?¢ Incidence of non-serious AEs of special interest â?¢ Cases of drug-induced liver injury meeting Hyâ??s law criteria â?¢ Incidence of CHF â?¢ Left Ventricular ejection fraction (LVEF) decrease over the course of the study as measured by ECHO â?¢ Laboratory results abnormalities â?¢ Incidence of AEs leading to discontinuation, modification, or interruption of study medication â?¢ Exposure to study medication | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measures for this study are on efficacy evaluationTimepoint: â?¢ Progression-free survival (assessed by RECISTv1.1) â?¢ Overall survival (OS) â?¢ Overall response rate (assessed by RECISTv1.1) | — |
Countries
India
Contacts
Public ContactPriyanka Bhattacharya
Roche Products (India) Pvt. Ltd.
Outcome results
None listed