SWOG clinical trial number
S0012

A Comparative Randomized Study of Standard Doxorubicin And Cyclophosphamide Followed by Weekly Paclitaxel Vs. Weekly Doxorubicin And Daily Oral Cyclophosphamide Plus G-CSF Followed by Weekly Paclitaxel As Neoadjuvant Therapy For Inflammatory And Locally Advanced Breast Cancer

Closed
Phase
III
Accrual
100%
Published
Abbreviated Title
NEOADJUVANT: Standard AC vs. Weekly A and Daily Oral C + G-CSF
Activated
05/01/2001
Closed
12/01/2005
Participants
NCORP, Members, Medical Oncologists, Pathologists, EPP, CTSU, Affiliates

Research committees

Breast Cancer

Treatment

Cyclophosphamide Doxorubicin Filgrastim Trimethoprim sulfa Surgery

Eligibility Criteria Expand/Collapse

Women with histologically confirmed locally advanced or inflammatory breast carcinoma; selected Stage IIB (T3, N0, M0) or IIIA (T3, N1-2, M0 or T0-2, N2, M0); primarily unresectable; Stage IIIB (T4, Any N, M0) or (Any T, N3, M0); no distant metastases, no prior chemotherapy or hormonal therapy for breast cancer; no prior RT or prior definitive surgery for breast cancer; chest x-ray, scans; no congestive heart failure or angina pectoris; patients with hypertension or > 60 years must have MUGA or echocardiogram and LVEF% > ILLN; serum creatinine and bilirubin <= IULN; SGOT/SGPT <= 2 x IULN; ANC >= 1,500; platelets >= 100,000; no known HIV; no pregnant or nursing women. For patients who consent for submission of samples for clonal hematopoiesis testing, a pretreatment sample must be submitted as specified in the protocol.

Publication Information Expand/Collapse

2018

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

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

The association between ASCO Value framework and scientific and clinical impact of SWOG phase III clinical trials

V Nghiem;R Vaidya;M Banegas;D Hershman;J Unger AcademyHealth Annual Research Meeting (June 23-26, 2018, Seattle, WA), poster

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 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

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

2014

Comparison of survival outcomes among cancer patients treated in and out of clinical trials

J Unger;W Barlow;DP Martin;S Ramsey;M Leblanc;R Etzioni;D Hershman Journal of the National Cancer Institute 106(3):dju002; 2014 Mar 13 [Epub ahead of print];

PMid: PMID24627276 | PMC number: PMC3982777

2011

SWOG 0012: a phase III comparison of standard doxorubicin and cyclophosphamide versus weekly doxorubicin and daily oral cyclophosphamide plus G-CSF as neoadjuvant therapy for inflammatory and locally advanced breast cancer [PMID21220618; PMC3024910]

G Ellis;W Barlow;J Gralow;G Hortobagyi;C Russell;M Royce;E Perez;D Lew;R Livingston Journal of Clinical Oncology 29(8):1014-1021;

2010

Screening for clonal hematopoiesis as a predictive marker for development of therapy-related myeloid neoplasia (t-MN) following neoadjuvant therapy for breast cancer: a Southwest Oncology Group study (S0012) [PMID19851858; PMC3024910]

ML Slovak;V Bell;D Lew;KS Albain;GK Elllis;RB Livingston;S Martino;EA Perez;GN Hortobagyi;D Sher;W Stock Breast Cancer Research and Treatment 119(2):391-398

2007

Screening for clonal hematopoiesis as a predictive marker for development of t-AML following adjuvant therapy for breast cancer (S0012)

ML Slovak;V Bedell;D Lew;KS Albain;GK Ellis;RB Livingston;S Martino;EA Perez;D Sher;W Stock Proc of the American Society of Clinical Oncology, Journal of Clinical Oncology 25(18S):#11051

2006

SWOG 0012, a randomized phase III comparison of standard doxorubicin (A) and cyclophosphamide (C) followed by weekly paclitaxel (T) versus weekly doxorubicin and daily oral cyclophosphamide plus G-CSF (G) followed by weekly paclitaxel as neoadjuvant therapy for inflammatory and locally advanced breast cancer

GK Ellis;SJ Green;CA Russell;ME Royce;EA Perez;RB Livingston Proc of the ASCO, Journal of Clinical Oncology 24(18S):#LBA537

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