Using Trastuzumab before surgery for HER2 positive breast cancer
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
This study is testing if giving Trastuzumab before surgery can help women with operable HER2 positive breast cancer have better outcomes.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Tata Memorial Hospital Government |
| Drugs / interventions | Trastuzumab, chemotherapy, radiation |
| Locations | 1 site (Mumbai) |
| Trial ID | NCT01785420 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of Trastuzumab, a monoclonal antibody, as a pre-operative treatment for women with operable HER2 positive breast cancer. The study aims to determine if administering Trastuzumab before surgery can improve outcomes by targeting cancer cells that overexpress the HER2 receptor. Participants will receive either Trastuzumab or a placebo, and their responses will be monitored to assess the effectiveness of the treatment. The trial focuses on patients with specific stages of breast cancer that are resectable.
Who should consider this trial
Good fit: Ideal candidates for this study are female patients aged 18 or older with histologically confirmed HER2 positive breast cancer that is operable.
Not a fit: Patients with HER2 negative breast cancer or those with metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of surgery and improve survival rates for patients with HER2 positive breast cancer.
How similar studies have performed: Previous studies have shown promising results with pre-operative Trastuzumab in similar patient populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:a.
1. Female subjects aged 18 years or older.
2. Histologically and/or cytologically confirmed diagnosis of breast cancer. Clinical stages breast cancer: HER2 positive, T1 or T2 or T3, N0 or N1, resectable T4, or resectable N2, (all M0)
3. Documentation of erbB-2 gene amplification by FISH (as defined by a ratio \>2.2) or chromogenic in situ hybridization (CISH, as defined by the manufacturer's kit instruction) or documentation of erbB-2-overexpression by IHC (defined as IHC3+, or IHC2+ with FISH or CISH confirmation) based on local laboratory.
4. LVEF within institutional range of normal as measured by MUGA or ECHO.
5. Screening laboratory values within the following parameters:
1. Absolute neutrophil count (ANC) ≥1.5 x 109 /L (1500/mm3)
2. Platelet count ≥100 x 109/L (100,000/mm3)
3. Hemoglobin ≥9.0 g/dL (90 g/L)
4. Serum creatinine ≤1.5 x upper limit of normal (ULN)
5. Total bilirubin ≤1.5 x ULN (\<3 ULN if Gilbert's disease) 6Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)
* 2.5 x ULN
Exclusion Criteria:
1. Bilateral breast cancer
2. 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).
3. Inadequately controlled hypertension (ie, systolic blood pressure \[BP\] \> 180 mm Hg or diastolic BP \> 100 mm Hg).
4. 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).
5. Significant chronic gastrointestinal disorder with diarrhea as a major symptom (eg, Crohn's disease, malabsorption, or grade ≥2 diarrhea of any etiology at baseline).
6. Women who are pregnant, breast-feeding.
Where this trial is running
Mumbai
- Tata Memorial Centre — Mumbai, India (Recruiting)
Study contacts
- Principal investigator: Rajendra A Badwe, MS — Director and professor, Surgical Oncology
- Study coordinator: Rajendra A Badwe, MS
- Email: badwera@gmail.com
- Phone: 91-22-21477000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.