Study to know the usefulness of Trastuzumab Emtansine medicine in widespread breast cancer patients

Phase 3

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

• Registration Number: CTRI/2019/08/020544
• Lead Sponsor: Hetero Biopharma Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Female patients of age 18 to 65 years (both inclusive)

2. Ability to comply with study and follow-up procedures and provide written informed consent

3. Have pathologically confirmed, measurable invasive metastatic breast cancer.

4. Documented evidence of HER2-overexpression

5. Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced, or metastatic setting

6. Documented progression (which occur during or after most recent treatment or within 6 months

7. Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

Exclusion Criteria

1. Prior treatment with Trastuzumab emtansine, lapatinib, or capecitabine

2. Peripheral neuropathy of grade 3 or higher

3. Male patients with metastatic breast cancer

4. Patients with current clinical or radiographic evidence of central nervous system

5. Current dyspnea at rest due to complications of advanced malignancy or current requirement for continuous oxygen therapy

6. Patients with an abnormal LVEF ( <50%)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare best Objective Response Rate (ORR) at tumor <br/ ><br>assessment time pointsTimepoint: Baseline & End of Cycle 2, 4, 6, 8

Secondary Outcome Measures

Name	Time	Method
Comparative incidence and titres of anti-Trastuzumab <br/ ><br>Emtansine antibodies over study periodTimepoint: Baseline & End of Cycle 4, 8;Compare single dose pharmacokinetic parameters of two formulations of Trastuzumab EmtansineTimepoint: Cycle 1;Exploratory shed HER2 extracellular domain (ECD) levels over study periodTimepoint: Baseline & End of Cycle 4, 8;Progression free survival (PFS) rate at the end of studyTimepoint: End of Cycle 8