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Randomized Phase II Study of Dose-Dense Fluorouracil Plus Epirubicin 75 Plus Cyclophosphamide (FEC75) and Fluorouracil Plus Epirubicin 90 Plus Cyclophosphamide (FEC90) as Adjuvant Therapy for Early Breast Cancer


Phase 2
18 Years
75 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Randomized Phase II Study of Dose-Dense Fluorouracil Plus Epirubicin 75 Plus Cyclophosphamide (FEC75) and Fluorouracil Plus Epirubicin 90 Plus Cyclophosphamide (FEC90) as Adjuvant Therapy for Early Breast Cancer


Arm A: the FEC75 regimen will be given at the following doses:

Fluorouracil 500mg/m2 by i.v. bolus or infusion. Epirubicin 75mg/m2 by 30 minutes i.v
infusion and Cyclophosphamide 500mg/m2 by i.v bolus or infusion. All three drugs will be
administered intravenously on Day 1 of each 14-day cycles.

Arm B: the FEC90 regimen will be given at the following doses:

Fluorouracil 500mg/m2 by i.v. bolus or infusion.Epirubicin 90mg/m2 by 30 minutes i.v
infusion and Cyclophosphamide 500mg/m2 by i.v bolus or infusion.

All three drugs will be administered intravenously on Day 1 of each 14-day cycles.

Pegfilgrastim fixed dose of 6mg as a single subcutaneous injection will be given in both
arms on Day 2 of each cycle.

Six cycles of adjuvant chemotherapy will be administered in both arms (A + B)


Inclusion Criteria:



- patients with histological diagnosis of invasive breast cancer

- Patients with early stage I, II,III breast cancer amendable for complete surgical
resection.

- Patients with any nodal status

- Patients with ER and PR -negative tumors. In case of axillary involvement:any
hormonal receptors status.

- perfomance Status 0-1 on the ECOG Scale

- patients indicated for adjuvant chemotherapy

- No previous chemotherapy or radiotherapy

- Patients have to be randomized within 8 weeks after surgery. Its recommended that
patients will start chemotherapy within 1 month after surgical treatment.

Exclusion Criteria:

- active infection

- pregnancy/breast feeding

- serious concomitant systemic disorders incompatible with the study

- Second primary malignancy (expect in situ carcinoma of the cervix or adequately
treated basal cell carcinoma of the skin)

- Use of any other investigational agent within 4 weeks before enrollment into the
study

- Cocurrent administration of radiation therapy, chemotherapy, hormonal therapy or
immunotherapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary objective of this randomized phase II is to determine the relative dose intensity (RDI) of six adjuvant cycles of FEC75 and FEC90 regimens given every 14 days with pegfilgrastim (Neulasta) support in subjects with early breast cancer.

Safety Issue:

Yes

Principal Investigator

Thomas Brodowicz, Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

Univ. Klinik für innere Medizin I

Authority:

Austria: Federal Ministry for Health and Women

Study ID:

CECOG/Breast.2.2.005

NCT ID:

NCT00286819

Start Date:

April 2005

Completion Date:

September 2006

Related Keywords:

  • Breast Cancer
  • early breast cancer,
  • Fluorouracil
  • Breast Neoplasms

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