SWOG clinical trial number
S0221

"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"

Closed
Phase
III
Accrual
100%
Published
Abbreviated Title
ADJUVANT: Continuous Schedule AC + G Vs. Q 2 Week Schedule AC, followed by Paclitaxel
Activated
11/01/2003
Closed
01/15/2012
Participants
NCORP, Members, Medical Oncologists, Pathologists, CTSU, Affiliates

Research committees

Breast Cancer

Treatment

Cyclophosphamide Paclitaxel Doxorubicin Filgrastim Trimethoprim sulfa Pegfilgrastim AC

Eligibility Criteria Expand/Collapse

Histologically confirmed diagnosis of operable Stage I, II, or III invasive breast carcinoma with known estrogen or progesterone receptor status;

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

2018

Genome-wide meta-analyses identifies novel taxane-induced peripheral neuropathy-associated loci

L Sucheston-Campbell;A Clay;W Barlow;GT Budd;D Stram;C Haiman;X Sheng;L Yan;G Zirpoli;S Yao;C Jiang;K Owzar;D Hershman;KS Albain;D Hayes;H Moore;J Hobday;JA Stewart;C Isaacs;M Salim;J Gralow;G Hortobagyi;R Livingston;D Kroetz;C Ambrosone Pharmacogenetics and Genomics Feb;28(2):49-55

PMid: PMID29278617

Survival by Hispanic Ethnicity among Cancer Patients Participating in SWOG Clinical Trials

M Chavez-MacGregor;J Unger;A Moseley;S Ramsey;DL Hershman Cancer Apr 15;124(8):1760-1769; Jan 25 [Epub ahead of print]

PMid: PMID29370458 | PMC number: PMC5963502

Associations between self-reported diet during treatment and chemotherapy-induced peripheral neuropathy in a cooperative group trial (S0221)

J Mongiovi;G Zirpoli;R Cannioto;L Sucheston-Campbell;D Hershman;JM Unger;HCF Moore;JA Stewart;C Isaacs;TJ Hobday;M Salim;G Hortobagyi;JR Gralow;GT Budd;KS Albain;C Ambrosone;SE McCann Breast Cancer Research, 20:146

Association of Cardiovascular Risk Factors With Cardiac Events and Survival Outcomes Among Patients With Breast Cancer Enrolled in SWOG Clinical Trials

D Hershman;C Till;S Shen;J Wright;S Ramsey;W Barlow;J Unger Journal of Clinical Oncology Mar 27 [Epub ahead of print]

PMid: PMID29584550 | PMC number: PMC Journal - In Process

Survival by Hispanic Ethnicity Among Cancer Patients participating in SWOG Clinical Trials

A Moseley;M Chavez-MacGregor;J Unger;S Ramsey;D Hershman Society for Clinical Trials Annual Meeting (May 20-23 2018, Portland, OR), oral presentation

2017

Association between body mass index and cancer survival in a pooled analysis of 22 clinical trials

H Greenlee;J Unger;M Leblanc;S Ramsey;D Hershman Cancer Epidemiology Biomarkers & Prevention 2017 Jan;26(1):21-29; 2016 Dec 16. [Epub ahead of print]

PMid: PMID27986655 | PMC number: PMC5370550

Supplement use and chemotherapy-induced peripheral neuropathy in patients treated in a SWOG cooperate group trial (S0221): the DELCaP Study

G Zirpoli;S McCann;L Sucheston-Campbell;D Hershman;G Ciupak;W Davis;J Unger;H Moore;JA Stewart;C Isaacs;T Hobday;M Salim;R Livingston;G Hortobagyi;J Gralow;D Hayes;GT Budd;K Albain;C Ambrosone Journal of the National Cancer Institute Dec 1;109(12)

PMid: PMID29546345; PMC Journal - In Process

SWOG S0221 Updated: Comparison of two schedules of paclitaxel as adjuvant therapy for breast cancer (http://abstracts.asco.org/199/AbstView_199_184069.html)

GT Budd;W Barlow;HCF Moore;T Hobday;JA Stewart;C Isaacs;M Salim;JK Cho;K Rinn;KS Albain;HK Chew;GV Burton;TD Moore;G Srkalovic;BA McGregor;LE Flaherty;RB Livingston;JR Gralow;G Hortobagyi J Clin Oncol 35, 2017 (suppl; abstr 521); American Society of Clinical Oncology (ASCO) Annual Meeting (June 2-6, 2017, Chicago, IL), poster session

Association Between Cardiovascular Risk Factors and Cardiac Events Among Breast Cancer Patients Enrolled in SWOG Clinical Trials

D Hershman;C Till;J Wright;S Ramsey;W Barlow;JM Unger San Antonio Breast Cancer Symposium (December 5-9, 2017, San Antonio, TX), poster

2016

Supplement use and chemotherapy-induced peripheral neuropathy in breast cancer patients treated on SWOG study S0221

G Zirpoli;S McCann;L Sucheston-Campbell;D Hershman;G Ciupak;W Davis;J Unger;H Moore;J Stewart;C Isaacs;T Hobday;M Salim;R Livingston;G Hortobagyi;D Hayes;G Budd;K Albain;C Ambrosone American Association for Research Annual Meeting (April 16 - 20, 2016, New Orleans, LA), abst #3413, poster

Comorbidities and Risk of Chemotherapy-Induced Peripheral Neuropathy Among Participants 65 Years or Older in Southwest Oncology Group Clinical Trials

D Hershman;C Till;J Wright;D Awad;S Ramsey;W Barlow;L Minasian;J Unger Journal of Clinical Oncology Sep 1;34(25):3014-3022; 2016 Jun 20 [Epub ahead of print]

PMid: PMID27325863 | PMC number: PMC5012713

Comorbidities and risk of chemotherapy induced peripheral neuropathy among participants in SWOG clinical trials

DL Hershman;C Till;JD Wright;D Awad;S Ramsey;W Barlow;L Minasian;J Unger Journal of Clinical Oncology 34, 2016 (suppl; abstr 10001); American Society of Clinical Oncology Annual Meeting (June 3-7, 2016, Chicago, IL), oral presentation

2015

SWOG S0221: A phase III trial comparing chemotherapy schedules in high-risk early breast cancer

GT Budd;W Barlow;HCF Moore;T Hobday;JA Stewart;C Isaacs;M Salim;J Cho;K Rinn;K Albain;H Chew;GV Burton;TD Moore;G Srkalovic;BA McGregor;LE Flaherty;RB Livingston;DL Lew;JR Gralow;GN Hortobagyi Journal of Clinical Oncology 33(1):58-64

PMid: PMID25422488 | PMC number: PMC4268253

A genome-wide association study identifies novel loci associated with taxane-related sensory neuropathy in breast cancer patients enrolled in a cooperative group clinical trial (SWOG S0221)

L Sucheston-Campbell;A Clay;W Barlow;G Budd;DO Stram;C Haiman;L Yan;G Zirpoli;DL Hershman;KS Albain;DF Hayes;H Moore;T Hobday;JA Stewart;C Isaacs;M Salim;J Gralow;GN Hortobagyi;RB Livingston;S Yao;C Jiang;X Cheng;K Owzar;DL Kroetz;C Ambrosone American Association for Cancer Research (April 18 - 22, 2015, Philadelphia, PA), poster, abst #5489;

2014

Germline genetic variants in ABCB1, ABCC1, and ALDH1A1 and risk of hematological and gastrointestinal toxicities in a SWOG phase III trial S0221 for breast cancer

S Yao;L Sucheston;H Zhao;G Zirpoli;S Liu;W Barlow;HCF Moore;GT Budd;DL Hershman;W Davis;GL Ciupak;JA Stewart;C Isaacs;T Hobday;M Salim;G Hortobagyi;JR Gralow;R Livingston;K Albain;D Hayes;CB Ambrosone The Pharmacogenomic Journal 14(3):241-247;

PMid: PMID23999597 | PMC number: PMC3940691

Outcome of male patients and black patients enrolled in SWOG S0221, an intergroup chemotherapy study

G Budd;W Barlow;HCF Moore;T Hobday;JA Stewart;C Isaacs;M Salim;JK Cho;K Rinn;KS Albain;H Chew;GV Burton;TD Moore;G Srkalovic;B McGregor;LE Flaherty;R Livingston;D Lew;JR Gralow;GN Hortobagyi Journal of Clinical Oncology 32:5s (suppl; abstr 1016); ASCO Annual Meeting (May 30-June 3, 2014, Chicago, IL), poster highlights session;

Association between BMI at treatment initiation and cancer survival across multiple SWOG trials

H Greenlee;J Unger;M Leblanc;D Hershman AACR Research International Conference on Frontiers on Cancer Research Prevention (Sept 28-Oct 1, 2014, New Orleans, LA; poster

2013

Supplement use during an intergroup clinical trial for breast cancer (S0221)

G Zirpoli;P Brennan;C-C Hong;S McCann;G Ciupak;W Davis;J Unger;G Budd;D Hershman;HCF Moore;J Stewart;C Isaacs;T Hobday;M Salim;G Hortobagyi;J Gralow;K Albain;CB Ambrosone Breast Cancer Research and Treatment 137(3):903-913;

PMid: PMID23306462 | PMC number: PMC3552360

S0221: Comparison of 2 schedules of paclitaxel as adjuvant therapy for breast cancer

G Budd;W Barlow;HCF Moore;T Hobday;JA Stewart;C Isaacs;M Salim;JK Cho;K Rinn;K Albain;H Chew;GV Burton;TD Moore;G Srkalovic;B McGregor;L Flaherty;RB Livingston;D Lew;J Gralow;G Hortobagyi Journal of Clinical Oncology 31(suppl; abstr CRA1008); American Society of Clinical Oncology Annual Meeting, oral presentation;

2011

Effect of physician recommendation on multivitamin and antioxidant supplement use during chemotherapy in an adjuvant trial for breast cancer (SWOG S0221)

G Zirpoli;PM Brennan;CC Hong;SC McCann;JM Unger;GT Budd;D Hershman;J Stewart;C Isaacs;T Hobday;M Salim;G Hortobagyi;J Gralow;K Albain;DF Hayes;C Ambrosone American Association for Cancer Research 2011 Annual Meeting, accepted (poster);

Genetic predictors of taxane-induced neurotoxicity in a SWOG phase III intergroup adjuvant breast cancer treatment trial (S0221) [PMID21766209; PMC33532924]

L Sucheston;H Zhao;S Yao;G Zirpoli;S Liu;W Barlow;HCF Moore;G Budd;D Hershman;W Davis;G Ciupak;J Stewart;C Isaacs;T Hobday;M Salim;G Hortobagyi;J Gralow;R Livingston;K Albain;D Hayes;C Ambrosone Breast Cancer Research and Treatment, 130(3):993-1002;

First analysis of SWOG S0221: A phase III trial comparing chemotherapy schedules in high risk early breast cancer

GT Budd;WE Barlow;HCF Moore;TJ Hobday;JA Stewart;C Isaacs;M Salim;JK Cho;K Rinn;KS Albain;HK Chew;GV Burton;TD Moore;G Srkalovic;BA McGregor;LE Flaherty;RB Livingston;D Lew;J Gralow;G Hortobagyi Journal of Clinical Oncology 29: 2011 (suppl; abstr 1004); ASCO 2011 meeting, oral presentation

2009

Variants in the BRCA1/Fanconi-Anemia repair pathway and taxane-induced neuropathy in SWOG directed intergroup study S0221

LE Sucheston;H Zhao;S Yao;W Barlow;DL Hershman;GT Budd;W Davis;G Ciupak;J Stewart;C Isaacs;T Hobday;J Latreille;G Hortobagyi;J Gralow;R Livingston;K Albain;DF Hayes;CB Ambrosone San Antonio Breast Cancer Symposium, 2009, poster presentation, abst. #2001

1969

Observations on the mechanism of hemorrhagic toxicity in mithramycin (NSC-24599) therapy.

RW Monto;RW Talley;MJ Caldwell;WC Levin;MM Guest Cancer Research 29: 697-704

Other Clinical Trials

SWOG Clinical Trial Number
SWOG-7436

Combined Modality Therapy of Breast Carcinoma Phase III

Research Committee(s)
Breast Cancer
Activated
01/09/1975
Closed
07/18/1979
Accrual
100%
Closed
Phase
III
Published
SWOG Clinical Trial Number
SWOG-7827

Combined Modality Therapy For Breast Carcinoma Phase III

Research Committee(s)
Breast Cancer
Activated
07/16/1979
Closed
08/01/1989
Accrual
100%
Closed
Phase
III
Published