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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 also evaluate the role of polymorphisms in genes related to oxidative stress in relation to treatment outcomes.
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:
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| Measure | Description | Time Frame |
|---|---|---|
| Epidemiologic Questionnaire | Self administered questionnaire to evaluate use of antioxidant supplements in relation to toxicity | At baseline interview |
| Evaluate if variants in genes are associate with treatment related toxicities | Polymorphisms will be determined by sequencing as described in detail on the National Cancer Institute'sSNP500Cancer database | Prior to treatment |
| Evaluate if variants in genes are associate with treatment related toxicities | Polymorphisms will be determined by sequencing as described in detail on the National Cancer Institute'sSNP500Cancer database | Year 5 |
| Epidemiologic Questionnaire | Self administered questionnaire to evaluate use of antioxidant supplements in relation to disease free survival | every 6 months for 5 years |
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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:
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)
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Woman from SWOG trial S0221 with node-positive or high-risk node-negative breast cancer.
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30486865 | Derived | Mongiovi JM, Zirpoli GR, Cannioto R, Sucheston-Campbell LE, Hershman DL, Unger JM, Moore HCF, Stewart JA, Isaacs C, Hobday TJ, Salim M, Hortobagyi GN, Gralow JR, Thomas Budd G, Albain KS, Ambrosone CB, McCann SE. Associations between self-reported diet during treatment and chemotherapy-induced peripheral neuropathy in a cooperative group trial (S0221). Breast Cancer Res. 2018 Nov 28;20(1):146. doi: 10.1186/s13058-018-1077-9. |
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