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A Study in breast cancer patients to see how safe and effective is Dr. Reddy�s marketed drug "Trastuzumab"

A Prospective, Single arm, Multicentre, Post-marketing Study (Phase IV) to evaluate safety and efficacy of Dr. Reddy�s Trastuzumab (DRL_TZ) in Patients with HER2-Positive Cancer.

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/01/017214
Enrollment
200
Registered
2019-01-23
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: C50- Malignant neoplasm of breast

Interventions

Intervention1: Dr. Reddys trastuzumab: DRL_TZ, 8mg/kg-loading dose 6mg/kg-maintenance dose, 3 weekly upto 8 cycles total duration - 24 weeks Control Intervention1: NIL: NIL

Sponsors

Dr Reddys Laboratories Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Established histopathologically/cytologically confirmed diagnosis of HER2 positive breast cancer (early or metastatic) or metastatic gastric cancer with documented evidence of either IHC3+ or IHC2+ with fluorescence in situ hybridization (FISH) positivity; 2. Eligible to receive DRL_TZ treatment for EBC or MBC or MGC

Exclusion criteria

Exclusion criteria: 1. Male patients with breast cancer

Design outcomes

Primary

MeasureTime frame
To assess the safety of DRL_TZ in patients with HER2-positive cancerTimepoint: 6 months—

Secondary

MeasureTime frame
To evaluate the efficacy and immunogenicity of DRL_TZ in HER2-positive cancer patientsTimepoint: 6 months—

Countries

India

Contacts

Public ContactDr Naveen Reddy

Dr. Reddy�s Laboratories Ltd.

vinujosem@drreddys.com04044644000

Outcome results

None listed

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