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NCT Number: NCT00431080

Randomized Phase III Trial Comparing Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Axillary Lymph Node (+) Breast Cancer

Anthracycline-containing regimens are recommended as adjuvant treatment for women with node positive breast cancer. In at least three large randomized clinical trials the addition or sequential administration of a taxane (paclitaxel or docetaxel) to an antracycline-based regimen resulted in superior clinical outcome for women with node positive early breast cancer. In two large randomized studies the dose dense administration with G-CSF support of anthracycline-based and paclitaxel combination was superior to the same regimen administered every three weeks without growth factors as adjuvant therapy in women with axillary node positive breast cancer. In one randomized trial, docetaxel was proved superior to paclitaxel in women with metastatic breast cancer

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital of Crete, Heraklion, Crete, Greece

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About this study

This trial will compare the dose dense, G-CSF supported sequential administration of 4 cycles of 5-Fluoruracil (F) plus Epirubicin (E 75mg/m2) plus Cyclofosfamide (C) followed by 4 cycles of docetaxel versus 4 cycles of paclitaxel as adjuvant chemotherapy in women with axillary lymph node positive breast cancer

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma
  • Within 60 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.
  • Tumor involvement of at least one axillary lymph node
  • Absence of any clinical or radiological evidence of local or metastatic disease
  • Premenopausal or postmenopausal women aged 18-75 years old
  • Adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3)
  • Adequate liver (bilirubin <1.0 times upper limit of normal and SGOT/SGPT <2.5 times upper limit of normal) and renal function (creatinine <1.5mg/dl)
  • Adequate cardiac function (LVEF>50%)
  • Written informed consent

Exclusion criteria

  • Positive pregnancy test.
  • Psychiatric illness or social situation that would preclude study compliance.
  • Other concurrent uncontrolled illness.
  • Prior or concurrent antineoplastic therapy e.g. hormonal therapy, radiation therapy, chemotherapy, biological agents.
  • Previous history of other invasive malignancy other than non-melanomatous skin cancer.

Treatment and study plan

docetaxel

Drug

Docetaxel 75 mg/m2 as an IV infusion over 1h every two weeks for 4 cycles

Other names: Taxotere

paclitaxel

Drug

Paclitaxel 175 mg/m2 as an IV infusion over 3hrs every two weeks for 4 cycles

Other names: Taxol

Epirubicin

Drug

Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles

Other names: Farmorubicin

Cyclophosphamide

Drug

Cyclophosphamide 700 mg/m2 IV push on day 1 every 4 weeks

Other names: Endoxan

5-fluoruracil

Drug

5-fluoruracil 700 mg/m2 IV push on day 1 every 4 weeks

Other names: 5-FU

Granulocyte-colony stimulating growth factor

Drug

rhG-CSF 5 μg/kg/d on days 3-10 after each cycle

Other names: Granocyte, Neulasta

Primary outcomes

  1. 3-year disease-free survival

    Time frame: 3 years

Secondary outcomes

  1. Overall survival

    Time frame: 3 years

  2. Recurrence rate

    Time frame: Relapses by the time of 3-years follow up

  3. Τoxicity profile

    Time frame: Toxicity assessment on each chemotherapy cycle

  4. Quality of life between the two treatment arms

    Time frame: Assessment every two cycles

Sponsors and collaborators

Lead sponsor

Hellenic Oncology Research Group

Other

Collaborators

  • University Hospital of Crete

Registry information

Official study title

A Multicenter Randomized Study Comparing the Dose Dense, G-CSF-Supported Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Women With Axillary Lymph Node Positive Breast Cancer

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Feb 5, 2007
Registry last updated
Jan 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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