Neoplasms

Skin and Connective Tissue Diseases

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Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

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Anti-Infective Agents

Docetaxel

Fluorouracil

Cyclophosphamide

Epirubicin

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Plasminogen Inactivators

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Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

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Antimetabolites

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Antibiotics, Antitubercular

Enzyme Inhibitors

3 courses FEC q3weeks followed by 3 courses Docetaxel q3weeks

Arm A 5-FU 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2 q3weeks followed by Docetaxel 100 mg/m² q3weeks

Arm B 5-FU 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2 q6weeks

5-Fluorouracil, Epirubicin, Cyclophosphamide, Docetaxel

Christoph Thomssen, MD

Nadia Harbeck, MD

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.

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)

6xFU/Epirubicin/Cyclophosphamide (FEC) Compared to 3xFEC-3xDocetaxel in High-risk Node-negative Breast Cancer Patients

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

German Breast Group

Martin-Luther-Universität Halle-Wittenberg

Prof. Dr. Christoph Thomssen

Symptoms and General Pathology

Carcinoma

Hyperplasia

Carcinoma in Situ

Carcinoma, Lobular

Breast Carcinoma In Situ

Precancerous Conditions

Carcinoma, Intraductal, Noninfiltrating

Carcinoma, Ductal, Breast

Herbal and Botanical

Flax

Patients ingest ground flaxseed daily, with already prepared foods, for 6 months.

Ground Flaxseed

Participants randomized to Arm 2 do not receive any intervention

No Intervention

Swati Kulkarni, M.D.

RATIONALE: Ground flaxseed may prevent breast cancer in premenopausal women at increased risk of developing primary breast cancer.

PURPOSE: This randomized clinical trial is studying how well flaxseed works in preventing breast cancer in premenopausal women at risk of breast cancer.

OBJECTIVES:

Primary aims:

* Determine if 25 grams of flaxseed supplementation daily

  * modifies proliferation (ki-67) and apoptotic rates after six months
  * modifies expression of estrogen regulated genes: Cyclin D1, survivin, and VEGF at six months
  * modifies serum IGF-1 and serum binding protein (IGFBP)-3 levels from baseline to 6 months
  * and evaluate the feasibility and tolerability of flaxseed consumption, and determine factors that lead to decreased compliance

STUDY OUTLINE:

This is a randomized study. Patients are randomized to 1 of 2 arms.

* Arm I (intervention): Patients ingest 25 grams ground flaxseed daily, with already prepared foods, for 6 months. Patients are instructed to record the time and with what foods flaxseed is consumed, and the number of bowel movements daily. Throughout the 6-month intervention period, patients also complete unannounced telephone-administered surveys recounting all foods and beverages consumed within the previous 24 hours.
* Arm II (observation): Patients do not receive ground flaxseed. All patients complete a diary about menstrual cycle duration and presence or improvement of premenstrual symptoms (e.g., cramping, bloating, headache, insomnia, or other irregular symptoms). Patients also complete questionnaires at 1, 3, and 6 months to access changes in diet, physical activity, menstrual history, demographic characteristics, and medical history and a specimen questionnaire at baseline and at 1, 3, and 6 months.

Blood and first-void urine samples are collected at baseline and at 1, 3, and 6 months to measure levels of lignan metabolites, flaxseed compliance, serum thiocyanate, malondialdehyde, and for biomarker studies by capillary gas chromatography-mass spectrometry, high-performance liquid chromatography, and ELISA.

After completion of study therapy, patients are followed monthly for up to 6 months.

Flaxseed in Preventing Breast Cancer in Premenopausal Women at Risk of Developing Breast Cancer

A Study Evaluating the Effect of Flaxseed on Biomarkers of Breast Cancer Risk

Roswell Park Cancer Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
6xFU/Epirubicin/Cyclophosphamide (FEC) Compared to 3xFEC-3xDocetaxel in High-risk Node-negative Breast Cancer Patients	NCT01222052	Breast Cancer	5-Fluorouracil,...	18 Years - 70 Years	Martin-Luther-Universität Halle-Wittenberg
Flaxseed in Preventing Breast Cancer in Premenopausal Women at Risk of Developing Breast Cancer	NCT00794989	Breast Cancer Precancerous Co...	Ground Flaxseed No Intervention	21 Years - 50 Years	Roswell Park Cancer Institute
Flaxseed in Preventing Breast Cancer in Premenopausal Women at Risk of Developing Breast Cancer	NCT00794989	Breast Cancer Precancerous Co...	Ground Flaxseed No Intervention	21 Years - 50 Years	Roswell Park Cancer Institute

Spots Global Cancer Trial Database for high risk breast cancer