"Phase III Trial of Continuous Schedule AC + G Vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High -Risk Node Negative Breast Cancer"
Research committees
Treatment
Eligibility Criteria Expand/Collapse
Patients with T4 tumors are not eligible;
Patients with bilateral synchronous breast cancer diagnosed within 1 month of each other are eligible;
Patients must be high risk by meeting one of the following criteria:
(1) tumor >/= 2 cm in greatest diameter (includes both invasive & intraductal component;
(2) tumor >/= 1 cm in diater and either ER-/PgR- OR ER+ or PgR+ with a Genomic Health Recurrence Score of >/= 26;
(3) one of more axillary or intramammary nodes are positive;
Either modified radical mastectomy or local excision of all tumors plus an axillary lymph node dissection or sentinel node resection prior to registration;
Patients must have at least 6 axillary or intramammary lymph nodes sampled, with the exception of patients who have a sentinel node procedure with all sampled nodes being uninvolved by malignancy;
Patients must be registered within 84 days from final surgical procedure;
No prior cytotoxic chemotherapy or chemotherapy with anthracycline, anthrcenedione, or taxane;
Co-enrollment in S0230, NSABP B-39, IBCSG 24-02 (SOFT), and IBCSG 25-02 (TEXT) are allowed;
No prior radiation therapy except for partial breast irradiation (PBI);
PBI must be completed at least 2 wks prior to registration;
RT for prior DCIS ok if done 2 wks before registration;
No clinical diagnosis for congestive heart failure or angina pectoris;
If history of hypertension or age >=60 years, MUGA, echocardiogram scan, or cardiac catheterization must be performed within 42 days prior to registration and LVEF %>= ILLN;
Serum creatinine and bilirubin <= IULN; alkaline phosphatase <= 2x IULN; SGOT/SGPT <= 2x IULN; ANC >= 1, 2000; platelet count >= 100,000;
No nursing or pregnant women;
No other prior malignancy is allowed except for the following: adequately trated basal cell or squamous cell skin cancer, in situ cervical cancer, lobular carcinoma in-situ or the breast (LCIS), or any other cancer from which the patient has been disease-free fro 5 years. Patients with prior invasive breast cancer or ductal carcinoma in-situ (DCIS) are eligible if they have been disease free for 5 years;
Age 18 or greater;
PS 0-2;
No known HIV;
For patients who consent to the genetic polymorphism sample submission, a pretreatment sample of 17 mL of blood (10 mL for banking and 7 mL for DNA extractions) must be submitted.
Women with HER2+ tumors may have trastuzumab added to their S0221 treatment.
Publication Information Expand/Collapse
2023
Vitamin D Insufficiency as a Risk Factor for Paclitaxel-Induced Peripheral Neuropathy in SWOG S0221
PMid: PMID37935109 | PMC number: PMC10976748
PMid: PMID37140922 | PMC number: PMC10160875
2021
2020
PMid: PMID31855498 | PMC number: PMC7062457
PMid: PMID32306168 | PMC number: PMC8218818
2018
Genome-wide meta-analyses identifies novel taxane-induced peripheral neuropathy-associated loci
PMid: PMID29278617 | PMC number: PMC5824720
Survival by Hispanic Ethnicity among Cancer Patients Participating in SWOG Clinical Trials
PMid: PMID29370458 | PMC number: PMC5963502
PMid: PMID30486865 | PMC number: PMC6264595
PMid: PMID29584550 | PMC number: PMC6127026
2017
Association between body mass index and cancer survival in a pooled analysis of 22 clinical trials
PMid: PMID27986655 | PMC number: PMC5370550
PMid: PMID29546345 | PMC number: PMC6075365
History of diabetes and outcome among participants 65 or older in SWOG clinical trials
PMid: PMID30657402 | PMC number: PMC6640843
2016
PMid: PMID27325863 | PMC number: PMC5012713
2015
SWOG S0221: A phase III trial comparing chemotherapy schedules in high-risk early breast cancer
PMid: PMID25422488 | PMC number: PMC4268253
2014
PMid: PMID23999597 | PMC number: PMC3940691
Outcome of male patients and black patients enrolled in SWOG S0221, an intergroup chemotherapy study
Association between BMI at treatment initiation and cancer survival across multiple SWOG trials
2013
Supplement use during an intergroup clinical trial for breast cancer (S0221)
PMid: PMID23306462 | PMC number: PMC3552360
2011
Effect of physician recommendation on multivitamin and antioxidant supplement use during chemotherapy in an adjuvant trial for breast cancer (SWOG S0221)
Genetic predictors of taxane-induced neurotoxicity in a SWOG phase III intergroup adjuvant breast cancer treatment trial (S0221) [PMID21766209; PMC33532924]
First analysis of SWOG S0221: A phase III trial comparing chemotherapy schedules in high risk early breast cancer
2009
Variants in the BRCA1/Fanconi-Anemia repair pathway and taxane-induced neuropathy in SWOG directed intergroup study S0221
1969
Observations on the mechanism of hemorrhagic toxicity in mithramycin (NSC-24599) therapy.