Clinical trial NCT00424606: Epirubicin and Docetaxel Combination (ET) or Epirubicin Followed by Docetaxel (E/T) for Node Negative (N0) High Risk Breast Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: High risk node negative
Lead sponsor: Hellenic Oncology Research Group
Sponsor class: OTHER
Collaborators: name: University Hospital of Crete
First posted: 2007-01-19
Enrollment: 658
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The combination of taxanes, and especially docetaxel, with an anthracycline seems to be an important part of the chemotherapy regimens used in the adjuvant setting of patients with early-stage node-positive breast cancer patients. Whether sequential or concurrent administration of these drugs is preferable is not yet known, especially in patients with node-negative high risk tumors.


Eligibility criteria: 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+) (after an amendment on 15.05.2008 women with HER2 (3+) were not included); 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.

Primary outcomes:
measure: Disease-free interval between the two treatment arms
timeFrame: Five years
Secondary outcomes:
measure: Comparison of overall survival and safety between the two treatment arms
timeFrame: Five years
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: University Hospital of Heraklion
state: Crete
city: Alexandroupolis
country: Greece
facility: University Hospital of Alexandroupolis Dept. of Medical Oncology
city: Athens
country: Greece
facility: "Agios Savvas" Anticancer Hospital of Athens
city: Athens
country: Greece
facility: "IASO" General Hospital of Athens
city: Athens
country: Greece
facility: "Laikon" General Hospital
city: Athens
country: Greece
facility: "Marika Iliadis" Hospital of Athens
city: Athens
country: Greece
facility: "Metaxa's" Anticancer Hospital of Pireas
city: Athens
country: Greece
facility: 401 Military Hospital of Athens
city: Athens
country: Greece
facility: Air Forces Military Hospital of Athens
city: Larissa
country: Greece
facility: State General Hospital of Larissa
city: Thessaloniki
country: Greece
facility: "AXEPA" General Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: "Theagenion" Anticancer Hospital of Thessaloniki
Study officials:
affiliation: University Hospital of Heraklion Dept. of Medical Oncology
name: Dimitris Mavrudis, MD
role: PRINCIPAL_INVESTIGATOR
References: