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:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT00159458
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven dx of recurrent or metastatic breast cancer
* Must have received at least 1 but not more than 3 prior chemotherapy regimens for recurrent or metastatic breast cancer. Patients who relapse within 12 months of completing adjuvant chemotherapy can only have had up to 2 prior regimens for metastatic disease. Patients who relapse within 12 months of completing adjuvant chemotherapy containing an anthracycline and a taxane, do not require prior chemotherapy for metastatic disease.
* Unidimensionally measurable dz (by RECIST)
* At least 18 yrs of age
* SWOG PS 0-2
* AGC greater than or equal to 1.5; platelets greater than or equal to 100,000; Hgb greater than or equal to 8.0
* Total bilirubin less than or equal to 2 x uln; SGOT and/or SGPT and alk phos up to 2.5 x uln
* Creatinine less than or equal to 2.0
* Fully recovered from acute toxicities secondary to prior tx
* Signed informed consent (including HIPAA authorization)
* Peripheral neuropathy grade 0-1
Exclusion Criteria
* Prior tx with gemcitabine or oxaliplatin. Prior tx with cisplatin or carboplatin allowed if completed \>12 mos prior to enrollment.
* Underlying medical, psychiatric, or social conditions that would preclude patient from receiving tx
* Peripheral neuropathy greater than or equal to Gr 2
Exclusion Criteria:
\-
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00159458
Study Brief:
Protocol Section:
NCT00159458