Clinical trial · Interventional
Adjuvant Treatment of Breast Cancer With 1-3 Aflicted Lymph Nodes
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+)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether a treatment with 4 cycles anthracycline + cyclophoshamide followed by administration of 4 cycles paclitaxel is more effective than therapy with 4 cy\<cles of anthracycline adminbistration followed by 4 cycles of paclitaxel
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide, Epirubicin, Paclitaxel | Drug | — | UNRESOLVED |
| Epirubicin, Paclitaxel, Filgrastim | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- interventionNames
- Drug: Cyclophosphamide, Epirubicin, Paclitaxel
- type
- EXPERIMENTAL
- label
- 2
- interventionNames
- Drug: Epirubicin, Paclitaxel, Filgrastim
Primary outcomes (1)
- measure
- progression-free time
- timeFrame
- every 3-6 months
Secondary outcomes (2)
- measure
- toxicity
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available