Patients with histologically confirmed stage I-III invasive carcinoma of the breast for whom adjuvant chemotherapy is indicated.
Conditions
Interventions
Trade Name: TAXOL
Product Name: PACLITAXEL
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: PACLITAXEL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration nu
Sponsors
GRUPO ESPAÑOL DE INVESTIGACIÓN EN CÁNCER DE MAMA (GEICAM)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: - Patients with histologically confirmed stage I-III invasive carcinoma of the breast for whom adjuvant chemotherapy is indicated. - Patients must have intact or measurable residual cancer (by mammogram, ultra sonogram or physical exam) in the breast. - Histological confirmation of invasive tumor needs to be performed on tissue obtained by either core needle biopsy or by partial surgical excision of the tumor. Routine estrogen, progesterone and HER-2 receptor determination must be requested on the initial diagnostic specimen. - Patients with a prior history of breast cancer are eligible. - Patients with bilateral breast cancers are eligible if willing to undergo pretreatment fine needle aspiration of both tumors. - Women of childbearing potential must have a negative pregnancy test (serum or urine beta HCG) prior to initiation of chemotherapy. - Patients should have adequate organ function to tolerate chemotherapy, as defined by: peripheral granulocyte count of > 1,500/mm3, platelet count > 100,000/mm3, billirubin within normal values, transaminase (SGPT) =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who have completed lumpectomy, segmental mastectomy or modified radical mastectomy and, therefore no longer have any measurable cancer left in their breast are not eligible. Patients with stage IV, metastatic breast cancers are not eligible. Patients for whom anthracycline or paclitaxel chemotherapies are contraindicated, for example: - hypersensitivity reactions to any of the medications - uncompensated congestive heart failure - myocardial infarction within the past 12 month - pre-existing peripheral neuropathy > grade 2 - prior anthracycline therapy with > cumulative dose of 240 mg/m2 Patients who are pregnant or lactating are not eligible. Women of childbearing potential who are not willing to use a contraceptive method during the study are not eligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objectives: - A main objective of this clinical trial is to prospectively evaluate the predictive accuracy of a previously discovered gene expression profile-based test to foretell pathologic complete response to preoperative (neoadjuvant) paclitaxel/FAC chemotherapy for stage I-III breast cancer. - The second main objective is to evaluate if our genomic predictive test is specific to the paclitaxel /FEC regimen or it also predicts increased sensitivity to FEC only chemotherapy. ;Secondary Objective: Secondary Objectives: - To discover a molecular profile that is associated with pathologic complete response to FEC chemotherapy alone (105 patients who receive FEC will be included in this analysis). - To establish a prospectively collected gene expression profile data bank of breast cancer for future studies. - Compare the pCR rates between patients all patients who receive 6 courses FEC and those who receive sequential paclitaxel /FEC chemotherapies. Long term relapse and survival data will also be collected.;Primary end point(s): The primary endpoint of this study is to assess the rate of pathologic complete response after completion of preoperative chemotherapy. | — |
Countries
Spain
Outcome results
None listed