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

A Randomized, Multiple-dose, Multicenter, Comparative Parallel Study to Evaluate the Efficacy, Safety and Pharmacokinetic Characteristics of Intravenous Infusion of Trastuzumab Emtansine (Hetero) and Reference Medicinal Product (Trastuzumab Emtansine, Roche) in Patients of HER2- positive Metastatic breast cancer - TREMBC STUDY

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/08/020544

Enrollment

153

Registered

2019-08-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Trastuzumab Emtansine (Hetero) (T): Test product will be administered 3.6 mg/kg given as an intravenous infusion every 3 weeks (21-day cycle) for 8 cycles or until disease progression (

Eligibility

Inclusion criteria

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

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%)

Design outcomes

Primary

Measure	Time frame
To compare best Objective Response Rate (ORR) at tumor assessment time pointsTimepoint: Baseline & End of Cycle 2, 4, 6, 8	—

Secondary

Measure	Time frame
Comparative incidence and titres of anti-Trastuzumab 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	—

Measure

Time frame

Comparative incidence and titres of anti-Trastuzumab 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

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Countries

India

Contacts

Public ContactDr SD Sinha

Hetero Labs Limited

sreenivasa.chary@heterodrugs.com04023704923

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026