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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00016406
First received: May 6, 2001
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Biological: filgrastim
Drug: cyclophosphamide
Drug: doxorubicin
Drug: paclitaxel
Procedure: surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Comparison of microscopic pathologic response rates [ Time Frame: no sooner than 21 days after chemo ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: during chemo and at surgery ] [ Designated as safety issue: Yes ]
  • Comparison of delivered dose intensity [ Time Frame: after chemo ] [ Designated as safety issue: No ]
  • Correlation of microscopic pathologic complete response with clinical complete response at the primary tumor site [ Time Frame: no sooner than 21 days after chemo ] [ Designated as safety issue: No ]

Enrollment: 399
Study Start Date: May 2001
Study Completion Date: February 2012
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AC followed by P
doxorubicin and cyclophosphamide followed by paclitaxel followed by surgery
Drug: cyclophosphamide
Other Name: cytoxan
Drug: doxorubicin
Other Name: Adriamycin
Drug: paclitaxel Procedure: surgery
Experimental: AC+G followed by P
weekly doxorubicin and daily cyclophosphamide with filgrastim followed by paclitaxel followed by surgery
Biological: filgrastim
Other Name: G-CSF
Drug: cyclophosphamide
Other Name: cytoxan
Drug: doxorubicin
Other Name: Adriamycin
Drug: paclitaxel Procedure: surgery

Detailed Description:

OBJECTIVES:

  • Compare the microscopic pathologic response rates in women with inflammatory or locally advanced breast cancer treated with standard neoadjuvant doxorubicin and cyclophosphamide followed by weekly paclitaxel vs weekly doxorubicin and daily oral cyclophosphamide with filgrastim (G-CSF) followed by weekly paclitaxel.
  • Compare the toxic effects of these regimens in this patient population.
  • Compare the delivered dose intensity of these regimens in this patient population.
  • Evaluate the association between microscopic pathologic complete response and clinical complete response at the primary tumor site in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease status (inflammatory vs other). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive doxorubicin IV followed by cyclophosphamide IV on day 1. Treatment repeats every 21 days for a total of 5 courses in the absence of disease progression or unacceptable toxicity. Three weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour weekly on day 1 for a total of 12 weeks.
  • Arm II: Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and filgrastim (G-CSF) subcutaneously on days 2-7. Treatment repeats weekly for a total of 15 courses of doxorubicin and cyclophosphamide and 16 courses of G-CSF in the absence of disease progression or unacceptable toxicity. One week after completion of G-CSF, patients receive paclitaxel as in arm I.

Within 3-6 weeks after completion of chemotherapy, patients with stable or responsive disease undergo surgical resection of tumor and affected nodes.

After surgery, patients may receive radiotherapy or additional chemotherapy and/or hormonal therapy at the discretion of the treating physician.

Patients are followed every 6 months for 1 year and then annually for 4 years.

PROJECTED ACCRUAL: A total of 350 patients (175 per treatment arm) will be accrued for this study within 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00016406

  Show 314 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Georgiana K. Ellis, MD Seattle Cancer Care Alliance
  More Information

Additional Information:
Publications:
Slovak 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.
Ellis GK, Green SJ, Russell CA, et al.: 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. [Abstract] J Clin Oncol 24 (Suppl 18): A-LBA537, 2006.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00016406     History of Changes
Other Study ID Numbers: CDR0000068630, S0012, U10CA032102
Study First Received: May 6, 2001
Last Updated: January 23, 2013
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
inflammatory breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Cyclophosphamide
Doxorubicin
Lenograstim
Liposomal doxorubicin
Paclitaxel
Adjuvants, Immunologic
Alkylating Agents
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014