Clinical trial · Interventional

S0012 Doxorubicin, Cyclophosphamide, and Paclitaxel With or Without Filgrastim in Treating Women With Inflammatory or Locally Advanced Breast Cancer

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

NCT00016406CI-TRIAL-00009080completedPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether combination chemotherapy is more effective with or without filgrastim in treating breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combining doxorubicin, cyclophosphamide, and paclitaxel with or without filgrastim in treating women who have inflammatory or locally advanced breast cancer.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
cyclophosphamide	Drug	Cyclophosphamide	ALIAS
doxorubicin	Drug	Doxorubicin	ALIAS
filgrastim	Biological	Filgrastim	ALIAS
paclitaxel	Drug	Paclitaxel	ALIAS
surgery	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
AC followed by P
description
doxorubicin and cyclophosphamide followed by paclitaxel followed by surgery
interventionNames
1. Drug: cyclophosphamide
2. Drug: doxorubicin
3. Drug: paclitaxel
4. Procedure: surgery
type
EXPERIMENTAL
label
AC+G followed by P
description
weekly doxorubicin and daily cyclophosphamide with filgrastim followed by paclitaxel followed by surgery
interventionNames
1. Biological: filgrastim
2. Drug: cyclophosphamide
3. Drug: doxorubicin
4. Drug: paclitaxel
5. Procedure: surgery

Primary outcomes (4)

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Histologically confirmed inflammatory or locally advanced breast cancer

  * Stage IIB (T3, N0, M0), IIIA (T3, N1-2, M0 or T0-2, N2, M0), or IIIB (T4, any N, M0 or any T, N3, M0)
  * Unresectable or otherwise appropriate for neoadjuvant therapy
  * Confirmed by core needle or incisional biopsy

    * Punch biopsy allowed if invasive disease is documented
* No distant metastases
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* Not specified

Sex:

* Female

Menopausal status:

* Not specified

Performance status:

* Zubrod 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than upper limit of normal (ULN)
* SGOT or SGPT no greater than 2 times ULN

Renal:

* Creatinine no greater than ULN

Cardiovascular:

* No congestive heart failure or angina pectoris
* LVEF greater than lower limit of normal

Other:

* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* HIV negative
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy for breast cancer

Endocrine therapy:

* No prior hormonal therapy for breast cancer

Radiotherapy:

* No prior radiotherapy for breast cancer

Surgery:

* No prior definitive surgery for breast cancer

Other:

* No other concurrent anticancer therapy

References

Publications (3)

RESULTSlovak ML, Bedell V, Lew D, et al.: Screening for clonal hematopoiesis as a predictive marker for development of t-AML following adjuvant therapy for breast cancer (S0012). [Abstract] J Clin Oncol 25 (Suppl 18): A-11051, 2007.
RESULTEllis GK, Barlow WE, Gralow JR, Hortobagyi GN, Russell CA, Royce ME, Perez EA, Lew D, Livingston RB. Phase III comparison of standard doxorubicin and cyclophosphamide versus weekly doxorubicin and daily oral cyclophosphamide plus granulocyte colony-stimulating factor as neoadjuvant therapy for inflammatory and locally advanced breast cancer: SWOG 0012. J Clin Oncol. 2011 Mar 10;29(8):1014-21. doi: 10.1200/JCO.2009.27.6543. Epub 2011 Jan 10. PMID 21220618
DERIVEDSlovak ML, Bedell V, Lew D, Albain KS, Ellis GK, Livingston RB, Martino S, Perez EA, Hortobagyi GN, Sher D, Stock W. 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). Breast Cancer Res Treat. 2010 Jan;119(2):391-8. doi: 10.1007/s10549-009-0597-5. PMID 19851858

Registry

Dates and enrollment

Start: May 1, 2001
Primary completion: Sep 1, 2006
Completion: Feb 1, 2012
First posted: Jan 27, 2003
Last update posted: Jan 24, 2013
Enrollment: 399 (actual)
Lead sponsor: SWOG Cancer Research Network NETWORK
Collaborators: National Cancer Institute (NCI)
Keywords: stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, inflammatory breast cancer

Data updated 22 days agoSource updated Jan 24, 2013source: clinicaltrials

Locations

Locations by country (314)

Country	Sites	Recruiting
United States	314	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.