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Simultaneous Study of Docetaxel Based Anthracycline Free Adjuvant Treatment Evaluation, as Well as Life Style Intervention Strategies


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Simultaneous Study of Docetaxel Based Anthracycline Free Adjuvant Treatment Evaluation, as Well as Life Style Intervention Strategies


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

Inclusion Criteria


Patients may be included in the study only if they meet all the following criteria:

1. Primary epithelial invasive carcinoma of the breast pT1-4, pN0-3, pM0

2. No evidence of HER2/neu overexpressing (IHC neg or +) or amplifying (FISH neg.) tumor

3. Histopathological proof of axillary lymph node metastases (pN1-3) or high risk node
negative, defined as at least one criterion of the following: 'pT ≥2,
histopathological grade 3, age ≤35, negative hormone receptor'

4. Complete resection of the primary tumor with margins of resection free of invasive
carcinoma not more than 6 weeks ago

5. Females ≥ 18 years of age

6. Performance status ≤ 2 on ECOG-Scale

7. Adequate bone marrow reserve: leucocytes ≥ 3.0 x 109/l and platelets ≥ 100 x 109/l

8. Bilirubin within the reference laboratory's normal range, ASAT (SGOT), ALAT (SGPT)
and AP within 1,5 fold of the reference laboratory's normal range for patients

9. Willingness to participate in a telephone-based lifestyle intervention programme
[10.] Intention of regular follow up visits for the duration of the study [11.]
Ability to understand the nature of the study and to give written informed consent

Patients will be excluded from the study for any of the following reasons:

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

60 months

Safety Issue:

No

Principal Investigator

Wolfgang Janni, Prof. Dr. med.

Investigator Role:

Study Director

Investigator Affiliation:

Klinikum der Heinrich-Heine-Universität Düsseldorf

Authority:

Germany: Ethics Commission

Study ID:

SUCCESS-C Trial

NCT ID:

NCT00847444

Start Date:

February 2009

Completion Date:

September 2016

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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