Pre Operative Trastuzumab in Operable Breast Cancer

Launched by DR RAJENDRA A. BADWE · Feb 6, 2013

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Trastuzumab (also known as Herceptin) in women with operable breast cancer that is HER2 positive. HER2 is a protein that can promote the growth of cancer cells. The trial aims to see if giving Trastuzumab for a short time before surgery can help reduce the chance of cancer coming back after treatment. About 1,000 women aged 18 and older who have been diagnosed with HER2 positive breast cancer at specific stages may be eligible to participate. To qualify, they must have confirmed breast cancer and meet certain health criteria.

Participants in the trial will be randomly assigned to receive either Trastuzumab or a placebo (a harmless saline solution) before their surgery. They will continue with standard post-surgery treatments like chemotherapy or radiation as needed. Throughout the trial, researchers will monitor the safety of the treatment and how it affects the patients' recovery. This study is important because it could help improve the outcomes for women with HER2 positive breast cancer by exploring new ways to prevent recurrence.

Gender

FEMALE

Eligibility 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.