6xFU/Epirubicin/Cyclophosphamide (FEC) Compared to 3xFEC-3xDocetaxel in High-risk Node-negative Breast Cancer Patients
Information source: Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: 5-Fluorouracil, Epirubicin, Cyclophosphamide, Docetaxel (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Martin-Luther-Universität Halle-Wittenberg Official(s) and/or principal investigator(s): Christoph Thomssen, MD, Principal Investigator, Affiliation: Dpt. Gynecology University Halle Germany Nadia Harbeck, MD, Principal Investigator, Affiliation: Breast Center University Cologne
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 criteria. Due to their high prognostic impact, the tumour-biological
invasion markers uPA/PAI-1 (urokinase-type plasminogen activator and its inhibitor PAI-1)
are potential candidates to effectively assess the risk of relapse in node-negative breast
cancer. This study is aimed to compare the risk assessment by the traditional
clinico-pathological factors and by tumour-biological factors. The second study question
refers to the comparison between an adjuvant combination treatment with FE100C*6 and a
sequential treatment with FE100C*3 and Docetaxel*3.
Clinical Details
Official title: Randomized Multicenter Study Comparing 6xFEC With 3xFEC-3xDoc in High-risk Node-negative Patients With Operable Breast Cancer: Comparison of Efficacy and Evaluation of Clinico-pathological and Biochemical Markers as Risk Selection Criteria
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Disease-Free Survival
Secondary outcome: Overall Survival
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, and toxicity of
chemotherapy in each patient group
2. To compare patients with low risk according to clinico-pathological versus those
according to biological risk criteria with regard to:
- the proportion of low risk versus high risk patients
- DFS
- OS (secondary endpoint)
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
GBG Forschungs GmbH, Neu-Isenburg 63263, Germany
Additional Information
Starting date: January 2002
Last updated: September 3, 2012
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