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

May 6, 2001
January 23, 2013
May 2001
September 2006   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00016406 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Biological: filgrastim
    Other Name: G-CSF
  • Drug: cyclophosphamide
    Other Name: cytoxan
  • Drug: doxorubicin
    Other Name: Adriamycin
  • Drug: paclitaxel
  • Procedure: surgery
  • Active Comparator: AC followed by P
    doxorubicin and cyclophosphamide followed by paclitaxel followed by surgery
    Interventions:
    • Drug: cyclophosphamide
    • Drug: doxorubicin
    • Drug: paclitaxel
    • Procedure: surgery
  • Experimental: AC+G followed by P
    weekly doxorubicin and daily cyclophosphamide with filgrastim followed by paclitaxel followed by surgery
    Interventions:
    • Biological: filgrastim
    • Drug: cyclophosphamide
    • Drug: doxorubicin
    • Drug: paclitaxel
    • Procedure: surgery

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
399
February 2012
September 2006   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00016406
CDR0000068630, S0012, U10CA032102
Yes
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Georgiana K. Ellis, MD Seattle Cancer Care Alliance
Southwest Oncology Group
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP