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A Multicenter Randomized Phase III Study of Adjuvant Treatment With Epirubicin Followed by Docetaxel (E/T) Versus Epirubicin and Docetaxel Combination (ET) in High Risk Lymph Node Negative Breast Cancer Patients


Phase 3
18 Years
75 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

A Multicenter Randomized Phase III Study of Adjuvant Treatment With Epirubicin Followed by Docetaxel (E/T) Versus Epirubicin and Docetaxel Combination (ET) in High Risk Lymph Node Negative Breast Cancer Patients


Inclusion Criteria:



- Histologically or cytologically confirmed breast adenocarcinoma.

- Within 20-45 days after the surgical excision of the primary tumor with tumor-free
operation margins; at least 10 axillary lymph nodes have to be removed.

- Absence of lymph node involvement after eclosion and hormone (E&H) staining and light
microscopy evaluation.

- Premenopausal or postmenopausal women with at least one of the following tumor
characteristics is required in order to characterize the tumor as high risk:

- Estrogen receptor (ER) (-) and progesterone receptor (PR)(-);

- Ki-67 + > 30%; Grade III; HER2 (3+);Perineural infiltration or presence of tumor
emboli in blood or lymph vessels.

- Postmenopausal women with tumors 1-2 cm are eligible if the tumor has at least 2 of
the above mentioned high risk criteria.

- Premenopausal and postmenopausal women with tumors measuring > 2 cm are eligible
irrespectively of the expression of the above adverse prognostic tumor criteria.

- Absence of any clinical or radiological evidence of local or metastatic disease.

- Age > 18 years.

- Performance status (WHO) < 3.

- Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count
> 100000/mm^3, hemoglobin > 9 gr/mm^3).

- Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times
upper limit of normal) and renal function (creatinine < 2 mg/dl).

- Adequate cardiac function (LVEF > 50%).

- Negative pregnancy test.

- Informed consent.

Exclusion Criteria:

- Other invasive malignancy within the past 5 years except nonmelanoma skin cancer.

- Other concurrent uncontrolled illness that could affect compliance with the study.

- Psychiatric illness or social situation that would preclude study compliance.

- Pregnant or nursing women.

- History of allergic reaction attributed to docetaxel.

- Other concurrent investigational agents.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Disease-free interval between the two treatment arms

Outcome Time Frame:

Five years

Safety Issue:

No

Principal Investigator

Dimitris Mavrudis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Heraklion Dept. of Medical Oncology

Authority:

Greece: National Organization of Medicines

Study ID:

CT/01.04

NCT ID:

NCT00424606

Start Date:

April 2002

Completion Date:

April 2013

Related Keywords:

  • Breast Cancer
  • High risk node negative
  • Breast Neoplasms

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