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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


Phase 3
18 Years
N/A
Not Enrolling
Female
Carcinoma Breast Stage I, HER2 Positive Breast Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Disease Free Survival

Outcome Description:

Survival follow-up visits (or information Collected via telephone call) will be conducted approximately every 6 months (ie, 24 weeks) starting from the last day of primary (adjuvant) treatment. The subject will be called at clinic and will be carefully examined by a member of study team. A mammogram will be done every 18 months. If patient is symptomatic,additional investigations will be performed. Subject status as alive, alive with disease will be documented in the source file.

Outcome Time Frame:

up to 5 yrs

Safety Issue:

Yes

Principal Investigator

Rajendra A Badwe, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Director and professor, Surgical Oncology

Authority:

United States: Food and Drug Administration

Study ID:

TMH Project-982

NCT ID:

NCT01785420

Start Date:

May 2013

Completion Date:

February 2021

Related Keywords:

  • Carcinoma Breast Stage I
  • HER2 Positive Breast Cancer
  • Pre-operative Trastuzumab Protocol
  • Breast Neoplasms
  • Carcinoma

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