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)

Breast Cancer Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00544505
• Other study ID #: RAC#931-006
• Status: Active, not recruiting
• Phase: N/A
• First received: October 15, 2007
• Last updated: December 11, 2011
• Start date: September 2007
• Est. completion date: September 2013

Study information

• Verified date: December 2011
• Source: King Faisal Specialist Hospital & Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: September 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• Fluorouracil/Epirubicin/Cyclophosphamide
Phase III Comparison of Preoperative vs Postoperative FEC (Fluorouracil/Epirubicin/Cyclophosphamide) in Women with Operable Breast Cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Faisal Specialist Hospital & Research Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy		overall	No