Pre-operative Chemotherapy in Operable Breast Cancer, Phase III Study Comparing a Short Intensive Pre-operative Chemotherapy With the Same Therapy Initiated Shortly After Surgery(Peri-operatively)(POCOB)EORTC 10902)

Pre-operative chemotherapy in operable breast cancer, phase III study comparing a short intensive pre-operative chemotherapy with the same therapy initiated shortly after surgery (peri-operatively) (POCOB) (EORTC 10902)

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Fluorouracil/Epirubicin/Cyclophosphamide

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy	overall

Collaborators and Investigators

• Sponsor: King Faisal Specialist Hospital & Research Center
• Investigators: Principal Investigator: Adnan Ezzat, MD, King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Anticipated): September 1, 2012
• Study Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: October 15, 2007
• First Submitted That Met QC Criteria: October 15, 2007
• First Posted (Estimate): October 16, 2007

Study Record Updates

• Last Update Posted (Estimate): December 13, 2011
• Last Update Submitted That Met QC Criteria: December 11, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Cyclophosphamide; Fluorouracil; Epirubicin
• Other Study ID Numbers: RAC#931-006