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Study of an alternative form of T-DM1 medicine for treating breast cancer with increased HER2 protein

Evaluation of Efficacy of Biosimilar T-DM1 in Adjuvant and Metastatic HER2-Positive Breast Cancer: A Retrospective Study from a Tertiary Cancer Centre. - RUBY STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/04/107289
Enrollment
500
Registered
2026-04-01
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Histologically confirmed invasive HER2-positive breast carcinoma (IHC 3+ and or FISH positive) 2.Treated with biosimilar T-DM1 (June 2021 onwards) in adjuvant or metastatic setting 3.Adequate clinical records available

Exclusion criteria

Exclusion criteria: 1. Prior intolerance or hypersensitivity to trastuzumab or T-DM1 2.Severe uncontrolled systemic illness 3.Incomplete or missing treatment/follow-up records

Design outcomes

Primary

MeasureTime frame
OS in all patients who recieved TDM1Timepoint: 3 years—

Secondary

MeasureTime frame
1. Progression free survival (PFS) in metastatic cohort 2. Disease free survival (DFS) in adjuvant cohort 3. Objective response rate (ORR) in metastatic patients 4. Incidence and severity of adverse events graded by NCI-CTCAE v5.0Timepoint: 3 years—

Countries

India

Contacts

Public ContactDr Prabhat Bhargava

Tata Memorial Center , Mumbai

bhargava611@gmail.com7276174221

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026