Dose Density FU 75 and FU 90 as Adjuvant Therapy for Early Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-09-30

Brief Summary

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This is an open -label randomized phase II study of dose-dense Fluorouracil/Epirubicin/Cyclophosphamide (FEC) administered with Epirubicin of 75mg/m2 (FEC75) and Epirubicin 90mg/m2 (FEC90) in untreated patients with early breast cancer.

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Detailed Description

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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)

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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the FEC75 regimen

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.

Group Type EXPERIMENTAL

the FEC75 and 95 regimen

Intervention Type DRUG

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

FEC90 regimen

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.

Group Type EXPERIMENTAL

the FEC75 and 95 regimen

Intervention Type DRUG

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

Interventions

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the FEC75 and 95 regimen

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No