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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

Page last updated: August 23, 2015

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