Status:
UNKNOWN
6xFU/Epirubicin/Cyclophosphamide (FEC) Compared to 3xFEC-3xDocetaxel in High-risk Node-negative Breast Cancer Patients
Lead Sponsor:
Martin-Luther-Universität Halle-Wittenberg
Collaborating Sponsors:
GBG Forschungs GmbH
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief Summary
In low-risk node-negative breast cancer patients adjuvant chemotherapy should be spared. The identification of this subgroup can be based either on clinical and pathological or on tumour-biological cr...
Detailed Description
1. To compare FEC\*6 with FEC\*3 followed by DOC\*3 with regard to: * the primary endpoint of the study: Disease-Free Survival (DFS) * the secondary endpoints: Overall Survival (OS), compliance...
Eligibility Criteria
Inclusion
- Histological proven primary breast cancer
- Tumour size \>0.5 cm and \<5 cm (pT1b-pT2, pN0, M0)
- Axillary lymph nodes tumour free (node-negative disease)
- Adequate surgical procedure: R0-resection and axillary dissection with more than 10 lymph nodes examined or adequate sentinel procedure in a qualified centre
- Frozen tumour tissue available (for analysis of biological markers and microarrays, centres with biological risk assessment only). The material has to be stored in liquid nitrogen immediately after excision.
- Paraffin blocks or (at least) pathology slides of primary tumour (stained and unstained) and axillary nodes (stained) available for central review.
- HER-2/neu determination by immunohistochemistry. Patients will be stratified to be HER-2/neu-negative or HER-2/neu-positive (HER-2/neu Score 3+, or HER-2/neu Score 2+ and FISH positive).
- No distant metastasis
- Age \>18 years, \<70 years
- Performance status ECOG \<2 (WHO Performance Status 0-1)
- Adequate cardiac function (echocardiographically measured left ventricular ejection fraction (LVEF) or shortening fraction (SF) within the normal limits, i.e. ≥55%)
- Adequate bone function (neutrophil count \>1.5 x109 /l and platelet count \>100 x109 /l)
- Adequate renal function (serum creatinine \<120 µmol/l or 1.35 mg/dl) and hepatic function (serum bilirubin \<1 x UNL, ASAT or ALAT (SGOT or SGPT) \<2,5 x UNL)
- Before patient registration/randomization, written informed consent must be obtained according to ICH/EU GCP, and national/local regulations
Exclusion
- Chemotherapy contraindicated
- Inflammatory breast cancer, tumour infiltrated axillary lymph nodes including the sentinel node.
- Other concomitant pathology compromising survival (at entry), or preventing the administration of chemotherapy with either FEC or Docetaxel
- Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study
- Estimated life-expectancy \<10 years (irrespective of breast cancer diagnosis)
- Patient not accessible for treatment and follow up
- Endocrine treatment not according to the latest standard recommendations of the AGO Kommission "Mamma"
- Pregnancy, lactation (sufficient non-hormonal contraception in fertile women required)
- Surgery more than six weeks ago at the start of chemotherapy
- Pre-existing polyneuropathy
- Previous or concomitant other malignancy (including contralateral breast cancer) except adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix
- Prior chemotherapy or radiotherapy or endocrine therapy
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2019
Estimated Enrollment :
4150 Patients enrolled
Trial Details
Trial ID
NCT01222052
Start Date
January 1 2002
End Date
February 1 2019
Last Update
June 26 2017
Active Locations (1)
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1
GBG Forschungs GmbH
Neu-Isenburg, Germany, 63263