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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


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease free survival

Outcome Time Frame:

5 y

Safety Issue:

No

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

SUCCESS-B

NCT ID:

NCT00670878

Start Date:

June 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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