Docetaxel Based Anthracycline Free Adjuvant Treatment Evaluation, as Well as Life Style Intervention

NCT ID: NCT00847444

Last Updated: 2013-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 3547 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2016-09-30

Brief Summary

This is an open-label, multicenter, 2x2 factorial design, randomized controlled, Phase III study comparing the disease free survival after randomisation in patients treated with 3 cycles of Epirubicine-Fluorouracil-Cyclophosphamide(FEC)-chemotherapy, followed by 3 cycles of Docetaxel(D)-chemotherapy, versus 6 cycles of Docetaxel- Cyclophosphamide (DC)-chemotherapy, and to compare the disease free survival in patients with BMI of 24 - 40 kg/m² after randomisation with versus without the lifestyle intervention. Patients will be required to have histopathological proof of a HER2/neu negative tumor and: axillary lymph node metastases (pN1-3) or high risk node negative, defined as: 'pT ≥2 or histopathological grade 3, or age ≤35 or negative hormone receptor status, but are not allowed to have evidence of distant disease. Patients will have to be entered into the study no later than 6 weeks after complete resection of the primary tumor. No other antineoplastic treatment other than surgical treatment, the defined cytotoxic and endocrine treatment and radiotherapy will be allowed prior to study entry and during the course of the study.

Detailed Description

Rationale:

• Taxane based chemotherapy will be established as treatment standard in the adjuvant setting of early breast cancer
• 3xFEC100, followed by 3xDoc100 has been established as standard treatment option for node-positive breast cancer
• Anthracycline based regimens do not seem to be superior in Her2/neu-negative patients (Gennari et al., Slamon et al.)
• Dietary intervention can improve outcome in patients with early breast cancer (WINS, Chlebowski et al.)

Primary Endpoints:

• The first primary objective of this study is to compare disease free survival after randomisation in patients treated with a combination of 5-FU/Epirubicine/Cyclophosphamide followed by Docetaxel vs. Docetaxel/Cyclophosphamide
• The second primary objective of this study is to compare disease free survival after randomisation in patients with vs. without lifestyle intervention

Design:

Prospectively randomized open label Phase III study with 2x2 factorial design

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AA

Drug intervention

Group Type: ACTIVE_COMPARATOR

Drug-based intervention

Intervention Type: DRUG

Randomization A AA: 3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicine 100 mg/m² i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day 22, subsequently followed by 3 cycles of Docetaxel 100 mg/m² body surface area i.v. (D), administered on day 1, repeated on day 22 AB: 6 cycles of Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² i.v. body surface area i.v. (DC), administered on day 1, repeated on day 22

BA

Lifestyle intervention

Group Type: ACTIVE_COMPARATOR

Lifestyle-based Intervention

Intervention Type: BEHAVIORAL

All Patients with a Body Mass Index (BMI) of 24 - 40 kg/m² at the time of enrollment will be subsequently randomized as follows:

Second randomization B BA: Lifestyle intervention program to reduce body weight comprising individual weight loss, diet and physical activity goals in the framework of a 2-year standardized and structured telephone and mail-based intervention.

BB

No individualized lifestyle intervention program.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Drug-based intervention

Randomization A AA: 3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicine 100 mg/m² i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day 22, subsequently followed by 3 cycles of Docetaxel 100 mg/m² body surface area i.v. (D), administered on day 1, repeated on day 22 AB: 6 cycles of Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² i.v. body surface area i.v. (DC), administered on day 1, repeated on day 22

Intervention Type: DRUG

Lifestyle-based Intervention

All Patients with a Body Mass Index (BMI) of 24 - 40 kg/m² at the time of enrollment will be subsequently randomized as follows:

Second randomization B BA: Lifestyle intervention program to reduce body weight comprising individual weight loss, diet and physical activity goals in the framework of a 2-year standardized and structured telephone and mail-based intervention.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Exclusion Criteria

1. Inflammatory breast cancer

2. Previous or concomitant cytotoxic or other systemic antineoplastic treatment which is not part of this study

3. A second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)

4. Cardiomyopathy with impaired ventricular function (NYHA > II), cardiac arrhythmias influencing LVEF and requiring medication, history of myocardial infarction or angina pectoris within the last 6 months, or arterial hypertension not being controlled by medication

5. Any known hypersensitivity against Docetaxel, Epirubicine, Cyclophosphamide, or any other medication included in the study protocol. The contraindication, warning notices and measures of precaution of the products, as notified in the product infroamtion, have to be respected

6. Use of any investigational agent within 3 weeks prior to inclusion

7. Patients in pregnancy or breast feeding (in premenopausal women anticonception has to be assured)

8. Insulin-requiring diabetes mellitus (non-insulin requiring patients with type 2 diabetes are eligible for the study)

9. Serious digestive and/or absorptive problems that exclude adherence to the study diet [10.] Self-reported inability to walk at least one kilometer (at any pace) [11.] Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Moderate arthritis that does not preclude physical activity is not a reason for exclusion [12.] Psychiatric disorders or conditions that would preclude participation in the study intervention [13.] Patients not sufficiently fluent in German language to understand the nature of this study and any of the interventional measures

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Philip Hepp

OTHER

Sponsor Role: lead

Responsible Party

Philip Hepp

Sponsors Representant

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Wolfgang Janni, Prof. Dr. med.

Role: STUDY_DIRECTOR

Klinikum der Heinrich-Heine-Universität Düsseldorf

Locations

Frauenklinik der Heinrich Heine Universität

Düsseldorf, , Germany

Countries

Germany

Related Links

http://www.success-studie.de

SUCCESS-Trial homepage

Other Identifiers

SUCCESS-C Trial

Identifier Type: -

Identifier Source: org_study_id