Studying the Benefits of Adjuvant Sequential vs. Combined Taxane Based Chemotherapy, Followed by Different Biological Treatment Strategies in Early, HER2-positive Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00670878
• Date of registration: 30/04/2008
• Primary sponsor: Ludwig-Maximilians - University of Munich
• Public title: Studying the Benefits of Adjuvant Sequential vs. Combined Taxane Based Chemotherapy, Followed by Different Biological Treatment Strategies in Early, HER2-positive Breast Cancer
• Scientific title: Prospectively Randomized Phase III Trial, Studying the Benefits of Adjuvant Sequential vs. Combined Taxane Based Chemotherapy, Followed by Different Biological Treatment Strategies in Early, HER2-positive Breast Cancer
• Date of first enrolment: June 2008
• Target sample size: 799
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00670878
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion Criteria:

- Primary epithelial invasive carcinoma of the breast pT1-4, pN0-3, M0

- Evidence of HER2-neu overexpressing (IHC +++) or amplifying (FISH +) tumor

- Histopathological proof of axillary lymph node metastases (pN1-3) or high risk node
negative, defined as at least two criteria of the following: 'pT³2, histopathological
grade 3, age £ 35, negative hormone receptor'

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

- Females >= 18 years of age

- Performance Status <2 on ECOG-Scale

- Adequate bone marrow reserve: leucocytes ³ 3.0 x 109/l and platelets ³ 100 x 109/l

- Bilirubin within one fold of 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

- Intention of regular follow up visits for the duration of the study

- Ability to understand the nature of the study and to give written informed consent

- Women of childbearing potential must agree to use an effective method of
contraception (Pearl-Index < 1, e.g. , intrauterine devices or sterilization) during
treatment and for at least 6 months thereafter.

Exclusion Criteria:

- Inflammatory breast cancer

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

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

- 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

- Any known hypersensitivity reaction against docetaxel, epirubicin, cyclophosphamide,
gemcitabine 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 information, have to be respected

- Instable diabetes mellitus, out of sufficient medical control

- Use of any investigational agent within 3 weeks prior to inclusion

- Patients in pregnancy or breast feeding (in premenopausal women contraception has to
be assured)



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: 3 x FEC 3 x DOC

Drug: 3 x FEC 3 x DOC / Gemcitabine

Primary Outcome(s)

Disease free survival [Time Frame: 5 y]

Secondary Outcome(s)

Changes in quality of life over time as defined by EORTC QLQ-C30 and QLQBR23 questionnaire [Time Frame: 5 Y]

Distant disease free survival [Time Frame: 5 Y]

Endpoints of adjunct translational research program [Time Frame: 5 Y]

Incidence of secondary primaries [Time Frame: 5 Y]

Overall survival time after randomization [Time Frame: 5 Y]

Skeletal related events [Time Frame: 5 Y]

Toxicity [Time Frame: 5 Y]

Secondary ID(s)

SUCCESS-B

Source(s) of Monetary Support

Please refer to primary and secondary sponsors