CompletedPhase 3ACTRN12611000506998

Epirubicin-Paclitaxel-Cyclophosphamide Methotrexate Fluorouracil (E-T-CMF) versus Epirubicin-Cyclophosphamide Methotrexate Fluorouracil (E-CMF) as adjuvant chemotherapy in high risk patients with operable breast cancer. A phase III study conducted by the Hellenic Cooperative Oncology Group (HE10/97)

High-risk patients with operable breast cancer treated with Epirubicin followed by Paclitaxel followed by Cyclophosphamide-Methotrexate-Fluorouracil (E-T-CMF) or Epirubicin followed by Cyclophosphamide-Methotrexate-Fluorouracil (E-CMF) as adjuvant chemotherapy to investigate the effect of the treatment on disease-free survival and overall survival.


Sponsor

Hellenic Cooperative Oncology Group

Enrollment

600 participants

Start Date

Jun 11, 1997

Study Type

Interventional

Conditions

Summary

The aim of this phase III, randomized study was to explore the effect of dose-dense sequential chemotherapy with or without paclitaxel primarily on disease-free survival (DFS) and secondarily on overall survival (OS) in patients with high-risk operable breast cancer. Acute toxicity and quality of life were also investigated. Translational research studies were also performed.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This phase III cancer trial compares two chemotherapy regimens for women with high-risk operable breast cancer. One group receives epirubicin, paclitaxel, and CMF (cyclophosphamide, methotrexate, fluorouracil), while the other receives epirubicin followed by CMF without paclitaxel. The goal is to determine which combination is more effective at preventing cancer recurrence after surgery.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

epirubicin [110 milligram/square meter (mg/m2) intravenously infused over 30 minutes] every 2 weeks for 3 cycles followed by 3 cycles of paclitaxel (250 mg/m2, intravenously infused over 3 hours) eve

epirubicin [110 milligram/square meter (mg/m2) intravenously infused over 30 minutes] every 2 weeks for 3 cycles followed by 3 cycles of paclitaxel (250 mg/m2, intravenously infused over 3 hours) every 2 weeks and 3 cycles of CMF (cyclophosphamide; 840 mg/m2, methotrexate; 57 mg/m2 and fluorouracil; 840 mg/m2 intravenously infused over 30 minutes) every 2 weeks


Locations(1)

Greece

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ACTRN12611000506998