ong term Safety and efficacy of Trastuzumab in Indian female patients with HER2+ breast cancer.

Phase 4

Conditions: Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Registration Number: CTRI/2024/01/061144

Lead Sponsor: Hetero Biopharma Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Female patients of age 18 and above

2. Patients willing to give written, signed, and dated informed consent to participate in the study

3. Patients with breast cancer with evidence of HER2-overexpression by immunohistochemistry (IHC) or HER2 gene amplification by fluorescence in situ hybridization (FISH) or positive chromogenic in-situ hybridization (CISH) result.

4. Patients with any other approved indication(s) as per the prescribing information at the discretion of principal investigator

Exclusion Criteria

1. Patients with history of hypersensitivity to the trastuzumab or to any of the excipients, or to murine proteins or any other chemotherapeutic agent planned along with Trastuzumab

2. Male patients with breast cancer

3. Patients treated with Trastuzumab as (neo)adjuvant within 12 months or for metastatic breast cancer (Hetero-Trastuzumab use for MBC is allowed)

4. Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest

5. Patients with a history or evidence of cardiovascular diseases including congestive heart failure (CHF) of Grade IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia, unstable angina pectoris, myocardial infarction

6. Patients who are pregnant or a nursing mother.

7. Patients received treatment with investigational drug in the last 90 days

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Significant clinical signs and symptoms developed during the treatment period. <br/ ><br>2. Significant changes observed in laboratory parameters during treatment period.Timepoint: 52 weeks

Secondary Outcome Measures

Name	Time	Method
1. Anti-Trastuzumab antibodies (ATA) against Hetero– Trastuzumab. <br/ ><br>2. Objective Response Rate or progression, whichever is earlier. <br/ ><br>3. Progression free survival (PFS) over study duration.Timepoint: 6 months and 12 months or progression, whichever is earlier.