Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-24 @ 10:08 PM
NCT ID:
NCT00235235
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the breast with locally advanced or metastatic disease.
* Disease amenable to pre-treatment core or incisional biopsy with adequate tissue for histology and genomic/proteomic analysis.
* Measurable disease as assessed within 21 days prior to being registered for protocol therapy by RECIST.
* Planned chemotherapy with one of the following regimens:
1. Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
2. Capecitabine 1000 mg/m2 BID days 1-14 of every 21-day cycle
3. Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle
4. Gemcitabine 1000 mg/m2 days 1, 8, 15 of every 28-day cycle
Exclusion Criteria:
* No serious uncontrolled medical or surgical condition that the investigator feels might compromise study participation.
* Negative pregnancy test obtained within 7 days prior to being registered for protocol therapy for women of child bearing potential.
* Unwillingness to use adequate contraception (or practicing complete abstinence). Subjects should be advised that adequate contraception (or complete abstinence) must be continued while on treatment and for a period of 3 months after the final dose of chemotherapy.
* No breast-feeding.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00235235
Study Brief:
Protocol Section:
NCT00235235