None listed
Conditions
Interventions
This group will be treated with Doxorubicin 60 mg / m2 IV in bolus or continuous infusion for 2-4 days + Cyclophosphamide 600 mg / m2 IV on day 1 of each cycle of 21 days for 4 cycles.
Group name:ARM D Type of group
This group will be treated with Gemcitabine 1000 mg / M2 IV on days 1, 8, 15 of 28-day cycles for 3 to 24 months.
Sponsors
HOSSIER ONCOLOGY GROUP,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histological and cytologic confirmation of locally advanced or metastatic breast adenocarcinoma. 2. Disease susceptible to pre-treatment core or incisional biopsy with adequate tissue sample for histology, and genomics / proteomics analysis. 3. Measurable and evaluated disease, between the 21 days prior to the start of the treatment protocol, using the RECIST criteria 4. Planning of chemotherapy with any of the study regimens. 5. Appropriate performance status and organic function. 6. Informed consent and authorization exempting the use of the personal health information. 7. Absence of other uncontrolled or surgical medical conditions that the investigator considers may compromise participation in the study. 8. Woman over 18 years old.
Exclusion criteria
Exclusion criteria: 1. Any other uncontrolled medical or surgical condition that may compromise your participation in the study. 2. Pregnancy. A negative pregnancy test must be obtained between the 7 days prior to registration for treatment of the protocol in women of childbearing age. 3. Refusal to have adequate contraception control. 4. Breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Core biopsy: Under ultrasound guidance, at least 6 biopsies will be obtained. The samples will be analyzed by SEADI mass spectrophotometry to obtain the genomic and proteomic profile. Measure:Association of genomic profiles to response to usual chemotherapy. Timepoints:Before starting the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Serum sample for proteomic analysis. Serum sample for pharmacogenomic analysis. Urine sample for pharmacogenomic analysis. Standard clinical and laboratory evaluation according to the treating physician s criteria. Measure:Correlation of proteomic profiles in serum and in the tumor with the response to commonly used chemotherapies. Correlation of toxicity and / or response a. specific drugs with pharmacogenomic parameters. Timepoints:Serum sample for proteomic analysis: At the beginning and 28 days after the last dose of chemotherapy of the first and last cycle. Serum sample for pharmacogenomic analysis: Initially, 2 hours and 24 hours after the first administration of chemotherapy. Urine sample for pharmacogenomic analysis: At the beginning and 4 hours after the first administration of chemotherapy. Clinical and laboratory evaluation: Each cycle. | — |
Countries
Peru
Outcome results
None listed