Metastatic HER2-negative breast cancer MedDRA version: 14.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Abraxane
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: PACLITAXEL
CAS Number: 33069-62-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type:
Sponsors
ONCOSUR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women with histologically or cytologically of stage IV breast cancer. 2. Non-candidate patient to trastuzumab or lapatinib treatment as not presenting HER2 oncogene amplification. 3. Metastatic disease not previously treated with chemotherapy. It is allowed pre-treatment hormone with anti-target or bisphosphonates for advanced disease. 4. Measurable or evaluable disease by RECIST criteria. 5. Previous sensory neuropathy = grade 1, according to NCI-CTCAE criteria, due to any reason. 6. Age> 18 years. 7. Performance status 10g/dl, WBC> 3000/mm3, platelets> 100000/mm3 and bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Prior chemotherapy treatment for metastatic disease. 2. Brain metastases. 3. Concomitant treatment with hormone therapy or immunotherapy for breast cancer, or during the two weeks prior to inclusion in the study. 4. Any concomitant medical or psychiatric illness including active infection. 5. History of any malignancy other than breast cancer in the past 5 years except carcinoma or basal cell skin carcinoma or carcinoma in situ of cervix. 6. Prior treatment with an investigational drug within the last 2 weeks. 7. Known hypersensitivity to paclitaxel or Cremophor. 8. Pregnant or breastfeeding. 9. Have any acute, subacute or chronic peripheral nerve or spinal cord in grade, at the time of inclusion, greater than or equal to 2 (NCI CTC AE v4.0).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize neurotoxicity according to Total Neuropathy Score;Primary end point(s): Total Neuropathy Score;Timepoint(s) of evaluation of this end point: Every 12 weeks;Secondary Objective: 1. Evaluate the incidence of neuropathy induced by study treatment (conventional paclitaxel vs nab-paclitaxel) 2. Evaluate the electromyographic abnormalities and the correlation of these alterations with the assessment of the TNS scale and NCI-CTCAE v4.0 3. Determine the predictive value of genetic variants (SNPs) for the development of neuropathy 4. Determine the clinical activity of both treatments. 5. Determine toxicity profile and safety of study treatments. 6. Determine time to neurotoxicity onset 7. Determine time to recovery from neurotoxicity 8. Determine time to progression (RECIST v1.1) 9. Assess quality of live (EORTC QLQ-C30 and EORTC QLQ-CIPN20). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Electromyographic alterations. 2. Cumulative dose of paclitaxel or nab-paclitaxel. 3. Assessment of neurotoxicity according to NCI-CTCAE v4.0 criteria. 4. Polymorphisms of cytochrome P450 (CYP2C8 and CYP3A5) and other genes (eg, ABCB1, RWDD3 and TECTA). 5. Classification of toxicity according to NCI CTCAE, version 4.0. The endpoint associated with toxicity will consist of the duration, intensity and time to onset of toxicity. The endpoints are safety adverse events of all kind, in addition to laboratory safety assessments, ECOG performance status and vital signs.;Timepoint(s) of evaluation of this end point: 1. Each 3 cycles 2. End of treatment 3. Every other week 4. Initial visit 5. Every other week | — |
Countries
Spain
Contacts
Public ContactSecretaria Técnica
ONCOSUR
Outcome results
None listed