Know Cancer

or
forgot password

Cyclophosphamid + Farmorubicin® With Subsequent Administration of Taxol® (q3w) Versus Intensified Administration of Farmorubicin® Followed by Taxol® (q2w) in the Adjuvant Treatment of Breast Cancer in Patients With 1-3 Afflicted Lymph Nodes (1-3 LK+)


Phase 3
18 Years
75 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Cyclophosphamid + Farmorubicin® With Subsequent Administration of Taxol® (q3w) Versus Intensified Administration of Farmorubicin® Followed by Taxol® (q2w) in the Adjuvant Treatment of Breast Cancer in Patients With 1-3 Afflicted Lymph Nodes (1-3 LK+)


Inclusion Criteria:



- women with histologically proven breast cancer (pT1/pT2/pT3, pN1, N0)

- ECOG performance status 0-1

- start of adjuvant therapy not later than 4 weeks after surgery

- hematology: platelets at least 100xGpt/l, neutrophiles at least 2xGpt/l

- normal liver function as defined by: bilirubine till 1.5 x normal value, SGOT/SGPT
till 1.25 x normal value

- normal kidney function as defined by: creatine till 1.5 x normal value

- negative pregnancy test for patients before menopause and effective contraception

- written informed consent

Exclusion Criteria:

- prior radiation, chemotherapy, hormontherapy and immunotherapy

- patients with more than 3 afflicted lymph nodes

- afflicted lymph nodes on the cantralateal side and/or afflicted supraclavicular or
intraclavicular lymph nodes

- bilateral breast cancer or second carcinoma of the breast

- inflammatory breast cancer and/or distant metastases

- existing clinically relevant peripheral neuropathie

- heart infection during the last 6 months or therapeutically not compensated heart
failure or cardiac arrhythmias of at least LOWN II

- patients with active infections and/or not controlled hypercalcemia

- pregnant or breastfeeding women or women of child-bearing age who do not use
effictive contrazeptiva

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:

progression-free time

Outcome Time Frame:

every 3-6 months

Safety Issue:

No

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

170200

NCT ID:

NCT00668616

Start Date:

March 2000

Completion Date:

July 2009

Related Keywords:

  • Breast Cancer
  • breast cancer with 1-3 afflicted axillary lymph nodes
  • Breast Neoplasms

Name

Location