PREDICTION OF RESPONSE AND TOXICITY IN PATIENTS WHO RECEIVE CHEMOTHERAPY FOR BREAST CANCER, CORRELATIVE STUDY OF GENOMICS, PROTEOMICS AND PHARMACOGENOMY

Not Applicable

• Conditions: -C509 Breast, unspecified; Breast, unspecified; C509

• Registration Number: PER-079-05
• Lead Sponsor: HOSSIER ONCOLOGY GROUP,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-02-08
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>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.<br>Measure:Association of genomic profiles to response to usual chemotherapy.<br><br>Timepoints:Before starting the treatment.<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Serum sample for proteomic analysis.<br>Serum sample for pharmacogenomic analysis.<br>Urine sample for pharmacogenomic analysis.<br>Standard clinical and laboratory evaluation according to the treating physician s criteria.<br>Measure:Correlation of proteomic profiles in serum and in the tumor with the response to commonly used chemotherapies.<br>Correlation of toxicity and / or response a. specific drugs with pharmacogenomic parameters.<br>Timepoints:Serum sample for proteomic analysis: At the beginning and 28 days after the last dose of chemotherapy of the first and last cycle.<br>Serum sample for pharmacogenomic analysis: Initially, 2 hours and 24 hours after the first administration of chemotherapy.<br>Urine sample for pharmacogenomic analysis: At the beginning and 4 hours after the first administration of chemotherapy.<br>Clinical and laboratory evaluation: Each cycle.<br>