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

Study Overview
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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.

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)

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: the FEC75 and 95 regimen


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the FEC75 regimen<br>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. | Drug: the FEC75 and 95 regimen<br>* 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<br>|
| Experimental: FEC90 regimen<br>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. | Drug: the FEC75 and 95 regimen<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Incidence of dose delays and dose reductions of planned chemotherapy due to neutropenic events |  |  | 
| -Toxicity and tolerability |  |  | 
| -disease Free survival (As neither radiotherapy nor hormone therapy are specified and will be carried out according to institutional guidelines, DST has t be interpreted with caution) |  |  | 
| - Quality of life |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early breast cancer,, Fluorouracil