Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: INTP26 of Intas Pharmaceuticals Limited, India: Dose: 150 mg/vial and 440 mg/vial
Frequency: 6 cycles (3-weekly regimen) or 18 cycles (weekly regimen)
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults >=18 years old. 2. HER2-positive metastatic breast cancer (patients either previously treated or not previously treated for their metastatic disease), OR HER2-positive early breast cancer, OR HER2-positive metastatic adenocarcinoma of stomach or gastroesophageal junction adenocarcinoma who have not received prior anti-cancer treatment for their metastatic disease Note: HER2-positive is defined as: o Immunohistochemistry (IHC) score of 3+ (IHC score of 2+ will be considered if FISH test is positive for HER2 receptor) or Fluorescence in situ hybridization (FISH) test positive for HER2 receptor. In case of early breast cancer, eligible patients receiving neoadjuvant or adjuvant therapy will be eligible. Patients who have received trastuzumab in neoadjuvant or adjuvant setting will be allowed for adjuvant / metastatic setting in the study. 3. Patient should be eligible for trastuzumab treatment as per the approved prescribing information of the product. 4. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) criteria Note: Measurable lesion criteria is not applicable for patients eligible for adjuvant therapy. 5. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2. 6. Normal left ventricular ejection fraction as per ECHO. 7. Understands the content of the protocol (including use of acceptable contraception during the study and until 6 months after the last dose of Trastuzumab), willing to provide informed consent and comply with protocol requirements.
Exclusion criteria
Exclusion criteria: 1. For females, a positive pregnancy test at screening or women who are lactating. 2. Males or WOCBP not willing to follow appropriate contraceptive measures during the course of study. 3. Known to have tested positive for HIV, HCV or HBsAg. 4. History of hypersensitivity to trastuzumab 5. Currently enrolled in or has not yet completed at least 30 days since ending another investigational device or drug trial(s), or patient is receiving another investigational agent(s). 6. History of substance abuse, including chronic alcoholism. 7. Life expectancy of less than 12 months. 8. Patients with NYHA Grade II (or more severe) congestive heart failure, clinically significant cardiac diseases (like, unstable angina pectoris, angina pectoris requiring treatment, myocardial infarction, valvular disease, cardiac arrhythmia) , cerebral infarction or transient ischemic attacks. 9. Uncontrolled hypertension even with treatment (systolic blood pressure [BP] >140 or diastolic BP >90mm Hg) or uncontrolled cardiac arrhythmias even with treatment (Patients with hypertension or arrhythmia controlled by therapies are eligible). 10. History of renal, hepatic, lung, immunological or haematological diseases that may affect patient safety as per the investigator. 11. Patients having active severe infections e.g., tuberculosis, sepsis and opportunistic infections. 12. Patients with brain metastasis. 13. Any of the following abnormal investigational values a. General: Any laboratory abnormality, which, in the opinion of the Investigator, would prevent the patient from completing the study or interfere with the interpretation of the study results. b. Liver transaminases: i. Serum aspartate aminotransferase (AST; serum glutamateoxaloacetic transaminase [SGOT]) >=2 Ã? upper limits of normal [ULN]; ii. Serum alanine aminotransferase (ALT; serum glutamate-pyruvate transaminase [SGPT]) >=2.0 Ã? ULN Alkaline phosphatase and bilirubin >=1.5 Ã? ULN (isolated bilirubin >=1.5ULN is acceptable if bilirubin is fractionated and direct bilirubin 35%)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of INTP26 in patients with HER2-overexpressing breast (early or metastatic) cancer or metastatic gastric cancer.Timepoint: Throught the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of INTP26 in patients with HER2-overexpressing breast (early or metastatic) cancer or metastatic gastric cancer.Timepoint: Screening, and at 6, 12 and 18 weeks | — |
Countries
India
Contacts
Public ContactMr Prashant Modi
Lambda Therapeutic Research Ltd
Outcome results
None listed