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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

Phase 3
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

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


- 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

- 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.

Inclusion Criteria


- 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



- Not specified


- Female

Menopausal status:

- Not specified

Performance status:

- Zubrod 0-2

Life expectancy:

- Not specified


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than upper limit of normal (ULN)

- SGOT or SGPT no greater than 2 times ULN


- Creatinine no greater than ULN


- No congestive heart failure or angina pectoris

- LVEF greater than lower limit of normal


- 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


Biologic therapy:

- Not specified


- No prior chemotherapy for breast cancer

Endocrine therapy:

- No prior hormonal therapy for breast cancer


- No prior radiotherapy for breast cancer


- No prior definitive surgery for breast cancer


- No other concurrent anticancer therapy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Comparison of microscopic pathologic response rates

Outcome Time Frame:

no sooner than 21 days after chemo

Safety Issue:


Principal Investigator

Georgiana K. Ellis, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Seattle Cancer Care Alliance


United States: Federal Government

Study ID:




Start Date:

May 2001

Completion Date:

February 2012

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • inflammatory breast cancer
  • Breast Neoplasms



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Meeker County Memorial Hospital Lichfield, Minnesota  55355
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Mid Dakota Clinic, P. C. Bismarck, North Dakota  58501
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David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
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Blanchard Valley Medical Associates Findlay, Ohio  45840
Fremont Memorial Hospital Fremont, Ohio  43420
Kenton Oncology, Incorporated Kenton, Ohio  43326
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Lima Memorial Hospital Lima, Ohio  45804
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Northwest Ohio Oncology Center Maumee, Ohio  43537
Middletown Regional Hospital Middletown, Ohio  45044
Toledo Clinic - Oregon Oregon, Ohio  43616
St. Charles Mercy Hospital Oregon, Ohio  43616
North Coast Cancer Care, Incorporated Sandusky, Ohio  44870
Firelands Regional Medical Center Sandusky, Ohio  44870
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Providence Milwaukie Hospital Milwaukie, Oregon  97222
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UMC Southwest Cancer and Research Center Lubbock, Texas  79415-3364
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University Hospital - San Antonio San Antonio, Texas  78229
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Southwest Washington Medical Center Cancer Center Vancouver, Washington  98668
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Joliet Oncology Hematology Associates, Limited - West Joliet, Illinois  60435
Baton Rouge General Regional Cancer Center Baton Rouge, Louisiana  70821
Rose Ramer Cancer Clinic at Anderson Area Medical Center Anderson, South Carolina  29621
St. Francis Hospital Federal Way, Washington  98003
St. Clare Hospital Lakewood, Washington  98499-0998
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Olympic Medical Center Port Angeles, Washington  98362
Good Samaritan Cancer Center Puyallup, Washington  98371
Valley Medical Center Renton, Washington  98055
St. Joseph Medical Center at Franciscan Health System Tacoma, Washington  98405-3004
Allenmore Hospital Tacoma, Washington  98411-0414
Saint Anthony Regional Hospital Carroll, Iowa  51401
Miller-Dwan Medical Center Duluth, Minnesota  55805
St. John's Hospital Maplewood, Minnesota  55109
Fremont Area Medical Center Fremont, Nebraska  68025-2387
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center Ft. Smith, Arkansas  72903
Valley Memorial Hospital Livermore, California  94550
Swedish American Hospital Rockford, Illinois  61104
St. Francis Hospital and Health Centers Beech Grove, Indiana  46107
Alegent Health Mercy Hospital Council Bluffs, Iowa  51503
Alegent Health Community Memorial Hospital Missouri Valley, Iowa  51555
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Saint Francis Cancer Center Shakopee, Minnesota  55379
St. Joseph's Hospital St Paul, Minnesota  55102
Woodwinds Hospital Woodbury, Minnesota  55125
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Altru Cancer Center at Altru Hospital Grand Forks, North Dakota  58201
Medical College of Ohio Cancer Institute Toledo, Ohio  43614
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All Saints Cancer Center at All Saints Healthcare Racine, Wisconsin  53405
St. Francis Medical Center Honolulu, Hawaii  96817
Auburn Regional Center for Cancer Care Auburn, Washington  98002
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Queen's Cancer Institute at Queen's Medical Center Honolulu, Hawaii  96813
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
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MedCentral - Mansfield Hospital Mansfield, Ohio  44903
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Center for Cancer Care at Goshen Health System Goshen, Indiana  46526
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Englewood Hospital and Medical Center Englewood, New Jersey  07631
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Highlands Oncology Group - Springdale Springdale, Arkansas  72764
Roper St. Francis Cancer Center at Roper Hospital Charleston, South Carolina  29401
Cancer Center of Kansas, P.A. - Dodge City Dodge City, Kansas  67801
Kapiolani Medical Center at Pali Momi Aiea, Hawaii  96701
Kapiolani Medical Center for Women and Children Honolulu, Hawaii  96826
Straub Clinic and Hospital, Incorporated Honolulu, Hawaii  96813
OnCare Hawaii, Incorporated - Kuakini Honolulu, Hawaii  96817
OnCare Hawaii, Incorporated - Lusitana Honolulu, Hawaii  96813
Medical and Surgical Specialists, L L C Galesburg, Illinois  61401
Hematology Oncology Consultants Ltd. Naperville, Illinois  60540
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields Olympia Fields, Illinois  60461
Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center Sioux City, Iowa  51101
Commonwealth Hematology-Oncology P. C. - Quincy Quincy, Massachusetts  02169
Ted B. Wahby Cancer Center at Mount Clemens General Hospital Mount Clemens, Michigan  48043
Lovelace Medical Center Albuquerque, New Mexico  87108
Cancer Care Center at Catskill Regional Medical Center Harris, New York  12742
United States Air Force Medical Center Wright-Patterson Wright-Patterson Afb, Ohio  45433-5529
Providence Centralia Hospital Regional Cancer Center Centralia, Washington  98531
Washington Hematology - Oncology Specialists Yakima, Washington  98902
North Star Lodge Cancer Center Yakima, Washington  98902