Status:
COMPLETED
Antioxidant Supplements, Genetics and Chemotherapy Outcomes
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Node Positive Breast Cancer
Node Negative Breast Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This study will investigate the null hypothesis that use of antioxidant supplements during adjuvant chemotherapy will have no impact on toxicities and disease-free, as well as overall, survival, and a...
Detailed Description
This study will enroll 3000 women from S0221with node positive or high-risk node-negative breast cancer receiving AC+T onto this ancillary study to address the following specific aims: 1. To characte...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed diagnosis of operable Stage 1, II, or III invasive breast cancer with known estrogen or progesterone receptor status
- high risk by meeting at least one of the following criteria:
- tumor \>= 2 cm in greatest diameter
- one or more axillary or intramammary nodes are involved by metastatic breast cancer
- had either a modified radical mastectomy or local excision of all tumors plus axillary node dissection or sentinel node resection
- not received prior chemotherapy or radiation therapy for the current malignancy
- no history of congestive heart failure or angina pectoris
- normal creatinine and bilirubin, alkaline phosphatase and SGOT or SGPT 2 x the institutional upper limits of normal
- ANC greater than or equal to 1,200 ul and platelet count of greater than or equal 100,000 U1
- No previous malignancies
- Age 18 or greater
- Performance status of 0 -2 by Zubrod criteria
- HIV negative (if known)
Exclusion
Key Trial Info
Start Date :
December 18 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 12 2013
Estimated Enrollment :
1771 Patients enrolled
Trial Details
Trial ID
NCT03413761
Start Date
December 18 2004
End Date
November 12 2013
Last Update
August 8 2022
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