therapeutic principles of primary systemic (=neo adjuvant) chemotherapy. In addition to the increased number of breast conserving operations, that could be already achieved by partially remission, the possibility of in vivo testing of chosen therapy (Kaufmann, 2003) showed that groups of patients whose tumors showed complete remission, had significant advantage considering cancer free survival and total survival. MedDRA version: 17.0 Level: PT Classification code 10006187 Term: Breast cancer S
Conditions
Interventions
Trade Name: Taxotere
Product Name: Docetaxel
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Docetaxel
CAS Number: 148408-66-6
Other descriptive name: DOCETAXEL
Sponsors
Technical University of Munich
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: age 18-65 locally advanced breast cancer histol. proof primary tumor >= 2cm Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: evidence of distant metastases by clinical diagnosis multifocal primary tumor, defined as histologically confirmed tumor-manifestations within different quadrants; distance = 4 cm pre-existing motor or sensory neuropathy of a severity = grade 2 NCI criteria previous breast cancer inflammatory breast cancer without bi-dimensional measure lesion prior systemic therapy for cancer previous therapy with Herceptin patients with immunosuppressive therapy invasive malignancy which could affect compliance with the protocol or interpretation of results. Patients who have been curatively treated and have been free of malignant disease for greater than 5 years are generally eligible. Inadequate bone marrow, hepatic and renal functions as evidence by the following: neutrophil count of 1.0 x ULN GBG (except for patients with clearly documented Gilbert's syndrome), ALT or AST > 1.5 x ULN alkaline phosphate > 2,5 x ULN, serum creatinine > 1,5 x ULN concurrent treatment with any other anti-cancer therapy known hypersensitivity reaction to the compounds or incorporated substances
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison: rate of pathologic complete remission following neo adjuvant therapy arm A (HER2+): with docetaxel and Herceptin vs rate of pathologic complete remission following neo adjuvant therapy arm B (HER2-) with docetaxel and correlation with predictive factors Tolerability: Documentation of nature and frequency of adverse events (AEs/SAEs);Secondary Objective: Rate of breast conserving therapy vs mastectomy in comparison to pre surgery estimation Rate of nodal negativity: comparison clinical/sonographic estimation vs. sonographic estimation pre surgery vs result of pathological examination Early respronse: Rate of clinical complete remission (cCR) after 4 cycles of docetaxel and 12 x Herceprin vs. 4 cycles docetaxel mono stratified in breast and axilla Clinical respronse Disease free survival after 2,5 and 5 years defined as relapse-free survival independent of relapse localization and stratification in patients with and without pathological CR (complete remission);Primary end point(s): Comparsion: rate of pathologic complete remission following neo adjuvant therapy arm A (HER2+) with Docetaxel and Herceptin vs rate of pathologic complete remission following neo adjuvant therapy arm B (HER2-) with Docetaxel and correlation with predictive factors Tolerability: Documentation of nature and frequency of adverse events (AEs / SAEs) | — |
Countries
Germany
Outcome results
None listed