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N/A
N/A
70 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information


Inclusion Criteria:



Disease Characteristics:

- Palpable, operable breast cancer that has been diagnosed by core needle biopsy
(mandatory for T1c tumors) or fine needle aspiration within 21 days prior to entry

- Stage T1c-4b, N0-1, M0

Hormone receptor status:

- Not specified

- No bilateral breast cancer

Prior/Concurrent Therapy:

- No previous treatment for breast cancer

Biologic therapy:

- Not specified

Chemotherapy:

- No previous chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Core needle biopsy or fine needle aspiration within 21 days prior to entry

- Repeated core needle biopsy permitted

Patient Characteristics:

Age:

- 16 to 70

Sex:

- Women only

Menopausal status:

- Not specified

Performance status:

- WHO 0-2

Hematopoietic:

- WBC at least 4,000

- Platelets at least 100,000

Hepatic:

- Bilirubin no greater than 2.8 mg/dL (50 micromoles/L)

Renal:

- Creatinine no greater than 1.3 mg/dL (120 micromoles/L)

Cardiovascular:

- No congestive heart failure

- No significant arrhythmia

- No bilateral bundle branch block

- No recent myocardial infarction

- No uncontrolled hypertension (diastolic pressure greater than 110 mm Hg)

Other:

- No male breast cancer

- No pregnant or nursing women

- No second malignancy except adequately treated:

- Nonmelanomatous skin cancer

- Cervical cancer

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy

Outcome Time Frame:

overall

Safety Issue:

No

Principal Investigator

Adnan Ezzat, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia

Authority:

United States: Institutional Review Board

Study ID:

RAC#931-006

NCT ID:

NCT00544505

Start Date:

September 2007

Completion Date:

September 2013

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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