Peri-operative Trastuzumab study for patients with operable breast cancer patients

A Phase III Double Blind Randomized Placebo Controlled study of Trastuzumab as Short Duration Preoperative Therapy in patients with HER2-neu Positive Operable Breast Cancer

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/12/004263

Enrollment

1100

Registered

2013-12-31

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: null- Operable Female Breast Cancer

Interventions

Intervention1: Injection Trastuzumab (Herceptin, Hoffman La Roche): A single dose of Trastuzumab (Herceptin, Hoffman La Roche) at 8 mg/Kg as a 90 minute infusion in 250 ml of normal saline, in the win

Eligibility

Inclusion criteria

Inclusion criteria: Confirmed Breast Cancr Patient

Exclusion criteria

Exclusion criteria: o Bilateral breast cancer o Active uncontrolled cardiac disease, including cardiomyopathy, CHF (New York Heart Association [NYHA] functional classification of >=3), unstable angina, and myocardial infarction (within 12 months of study entry). o Inadequately controlled hypertension (ie, systolic blood pressure [BP] > 180 mm Hg or diastolic BP > 100 mm Hg). o Family history of congenital long or short QT syndrome, Brugada syndrome or QT/QTc interval > 0.45 second or known history of QT/QTc prolongation or torsade de pointe (TdP). o Significant chronic gastrointestinal disorder with diarrhea as a major symptom (eg, Crohnâ??s disease, malabsorption, or grade >=2 diarrhea of any etiology at baseline). o Women who are pregnant, breast-feeding.

Design outcomes

Primary

Measure	Time frame
Disease free survival (DFS) in patients undergoing primary surgery for HER2 positive operable breast cancerTimepoint: At 5 years	—

Secondary

Measure	Time frame
To study the impact of a single pre-operative injection of Trastuzumab (versus placebo) in patients undergoing primary surgery for HER2 positive operable breast cancer on the following. â?¢The safety of the intervention â?¢Overall survival (OS) in the two arms â?¢The level of circulating tumor cells (CTCs) in the peripheral blood at defined time pointsTimepoint: The safety of the intervention,including on early post operative morbidity â?¢Overall survival is the time from the date of randomization until the date of death, censored at the last known date alive. â?¢Defined time points for circulating tumour cells in peripheral blood are as follows: 1)Immediately prior to study intervention ( 2) 10 minutes prior to start of surgery 3) During surgery 4) 10 days after surgery	—

Measure

Time frame

To study the impact of a single pre-operative injection of Trastuzumab (versus placebo) in patients undergoing primary surgery for HER2 positive operable breast cancer on the following. â?¢The safety of the intervention â?¢Overall survival (OS) in the two arms â?¢The level of circulating tumor cells (CTCs) in the peripheral blood at defined time pointsTimepoint: The safety of the intervention,including on early post operative morbidity â?¢Overall survival is the time from the date of randomization until the date of death, censored at the last known date alive. â?¢Defined time points for circulating tumour cells in peripheral blood are as follows: 1)Immediately prior to study intervention ( 2) 10 minutes prior to start of surgery 3) During surgery 4) 10 days after surgery

—

Countries

India

Contacts

Public ContactDr Vani Parmar

Tata Memorial Hospital

sudeepgupta04@yahoo.com91-22-24177201

Outcome results

None listed

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