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A RANDOMIZED TRIAL COMPARING PREOPERATIVE DOXORUBICIN (ADRIAMYCIN)/CYCLOPHOSPHAMIDE (AC) TO PREOPERATIVE AC FOLLOWED BY PREOPERATIVE DOCETAXEL (TAXOTERE) AND TO PREOPERATIVE AC FOLLOWED BY POSTOPERATIVE DOCETAXEL IN PATIENTS WITH OPERABLE CARCINOMA OF THE BREAST


Phase 3
N/A
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A RANDOMIZED TRIAL COMPARING PREOPERATIVE DOXORUBICIN (ADRIAMYCIN)/CYCLOPHOSPHAMIDE (AC) TO PREOPERATIVE AC FOLLOWED BY PREOPERATIVE DOCETAXEL (TAXOTERE) AND TO PREOPERATIVE AC FOLLOWED BY POSTOPERATIVE DOCETAXEL IN PATIENTS WITH OPERABLE CARCINOMA OF THE BREAST


OBJECTIVES: I. Compare overall and disease-free survival in patients with operable
adenocarcinoma of the breast treated with 4 courses of preoperative doxorubicin and
cyclophosphamide (AC) alone vs 4 courses of preoperative or postoperative docetaxel (TXT)
following 4 courses of preoperative AC. II. Evaluate whether the addition of preoperative
TXT to preoperative AC results in improved rates of clinical and pathologic locoregional
tumor response. III. Assess whether the addition of preoperative TXT to preoperative AC
results in improved rates of breast conservation. IV. Assess whether postoperative TXT
improves disease-free and overall survival in patients who receive preoperative AC,
especially in certain subgroups of patients (e.g., those with pathologically positive
nodes).

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age
(under 50 vs 50 and over), clinical tumor size (less than 2.1 cm vs 2.1-4.0 cm vs greater
than 4.0 cm), clinical nodal status (negative vs positive), and participating center.
Patients are randomized to one of three treatment arms. Arm I: Patients receive doxorubicin
IV followed by cyclophosphamide IV over 30 minutes to 2 hours on day 1 every 21 days for 4
courses. Patients receive oral tamoxifen daily for 5 years, starting on day 1. After
completion of chemotherapy, patients are offered surgery (e.g., lumpectomy with axillary
node dissection, or modified radical mastectomy). Post-operative radiotherapy is given
post-lumpectomy. Arm II: Patients receive doxorubicin IV followed by cyclophosphamide IV
over 30 minutes to 2 hours followed by docetaxel IV over 1 hour on day 1 once every 21 days
for 4 courses. Patients receive oral tamoxifen daily for 5 years, starting on day 1. After
the completion of chemotherapy, surgery is offered (as in arm I). Radiotherapy follows
surgery in post-lumpectomy patients. Arm III: Patients receive doxorubicin IV followed by
cyclophosphamide IV over 30 minutes to 2 hours on day 1 every 21 days for 4 courses.
Patients receive oral tamoxifen daily for 5 years, starting on day 1. After completion of
chemotherapy, surgery is offered (as in arm I). After surgical recovery, docetaxel IV is
given over 1 hour once every 21 days for 4 courses. Radiotherapy follows docetaxel in
post-lumpectomy patients. Chemotherapy is repeated every 21 days for 4 courses in the
absence of disease progression or unacceptable toxicity. Patients are followed every 6
months for 5 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 2,400 patients will be accrued for this study within 5
years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically proven invasive adenocarcinoma of
the breast Fine-needle aspiration is acceptable Core or Tru-cut biopsies are preferable No
more than 63 days between initial diagnosis and randomization Tumor palpable on clinical
exam and confined to the breast and ipsilateral axilla If clinically negative axillary
nodes (N0): primary tumor greater than 1 cm (T1c-T3) If clinically positive axillary nodes
(N1): any size primary tumor (T1-3) No N2 disease, i.e., ipsilateral nodes clinically
fixed to one another or to other structures No skeletal pain unless: Bone scan and/or
roentgenologic exam negative for metastatic disease Suspicious findings confirmed as
benign by x-ray, MRI, or biopsy No ulceration, erythema, skin infiltration (complete
fixation), or peau d'orange, or skin edema of any magnitude Tethering or dimpling of skin
or nipple inversion allowed No bilateral malignancy Suspicious contralateral mass proven
benign on biopsy allowed None of the following unless proven benign on biopsy: Suspicious
palpable nodes in contralateral axilla Palpable supraclavicular or infraclavicular nodes
Hormone receptor status: Any status

PATIENT CHARACTERISTICS: Age: Any age Sex: Female Menopausal status: Not specified
Performance status: Not specified Life expectancy: At least 10 years (exclusive of cancer
diagnosis) Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3
Hepatic: Bilirubin normal AST/ALT normal Alkaline phosphatase normal Renal: Creatinine
normal Cardiovascular: No active cardiac disease that would preclude doxorubicin, e.g.:
Documented myocardial infarction History of congestive heart failure Angina pectoris
requiring medication Valvular disease with documented cardiac function compromise
Arrhythmia associated with heart failure or cardiac dysfunction Poorly controlled
hypertension, i.e., diastolic blood pressure greater than 100 mm Hg Cardiomegaly on chest
x-ray or ventricular hypertrophy on EKG unless left ventricular ejection fraction at least
45% by MUGA Other: No other malignancy within the past 10 years except: Segmentally
resected lobular carcinoma in situ of the ipsilateral or contralateral breast Effectively
treated nonmelanomatous skin cancer Surgically treated carcinoma in situ of the cervix No
systemic disease that would preclude therapy No psychiatric or addictive disorder that
would preclude informed consent Geographically accessible for follow-up Not pregnant

PRIOR CONCURRENT THERAPY: No prior therapy for breast cancer No prior anthracyclines for
any malignancy No concurrent sex hormones (e.g., birth control pills or ovarian
replacement therapy)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Determine if 4 cycle of pre-op or post-op Taxotere given after 4 cycles of pre-op AC will more effectively prolong survival (S) than does 4 cycles of pre-op AC alone.

Outcome Time Frame:

Time from randomization to death from any cause.

Safety Issue:

No

Principal Investigator

Harry D. Bear, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Massey Cancer Center

Authority:

United States: Federal Government

Study ID:

NSABP B-27

NCT ID:

NCT00002707

Start Date:

December 1995

Completion Date:

February 2010

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms

Name

Location

Akron City HospitalAkron, Ohio  44304
Baylor College of MedicineHouston, Texas  77030
National Naval Medical CenterBethesda, Maryland  20889
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Medical University of South CarolinaCharleston, South Carolina  29425-0721
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Simmons Cancer Center - DallasDallas, Texas  75235-9154
St. Luke's Medical CenterMilwaukee, Wisconsin  53215
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
CCOP - WichitaWichita, Kansas  67214-3882
East Carolina University School of MedicineGreenville, North Carolina  27858-4354
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Baptist Cancer InstituteMemphis, Tennessee  38117
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
CCOP - Colorado Cancer Research Program, Inc.Denver, Colorado  80209-5031
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Northern New JerseyHackensack, New Jersey  07601
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
St. Vincent Hospital and Health Care CenterIndianapolis, Indiana  46260
CCOP - DuluthDuluth, Minnesota  55805
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
Henry Ford HospitalDetroit, Michigan  48202
Medical College of WisconsinMilwaukee, Wisconsin  53226
Huntsville Hospital SystemHuntsville, Alabama  35801
Sutter Health Western Division Cancer Research GroupGreenbrae, California  94904
Loma Linda University Medical CenterLoma Linda, California  92354
Beckman Research Institute, City of HopeLos Angeles, California  91010
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
Halifax Medical CenterDaytona Beach, Florida  32114
Memorial Hospital of South BendSouth Bend, Indiana  46601
Tulane University School of MedicineNew Orleans, Louisiana  70112
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Methodist Cancer Center - OmahaOmaha, Nebraska  68114
Newark Beth Israel Medical CenterNewark, New Jersey  07112
CCOP - ColumbusColumbus, Ohio  43206
CCOP - DaytonKettering, Ohio  45429
CCOP - Columbia River ProgramPortland, Oregon  97213
Lehigh Valley HospitalAllentown, Pennsylvania  18103
Mercy Hospital Cancer Center - ScrantonScranton, Pennsylvania  18501
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
York HospitalYork, Pennsylvania  17315
CCOP - GreenvilleGreenville, South Carolina  29615
University of Texas Medical BranchGalveston, Texas  77555-1329
Joe Arrington Cancer Research and Treatment CenterLubbock, Texas  79410-1894
CCOP - Southwestern Vermont Regional Cancer CenterBennington, Vermont  05201
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
CCOP - EvanstonEvanston, Illinois  60201
CCOP - Scott and White HospitalTemple, Texas  76508
CCOP - Marshfield Medical Research and Education FoundationMarshfield, Wisconsin  54449
Baptist Regional Cancer Institute - JacksonvilleJacksonville, Florida  32207
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Dwight David Eisenhower Army Medical CenterFort Gordon, Georgia  30905-5650
Boston Medical CenterBoston, Massachusetts  02118
Providence Hospital - SouthfieldSouthfield, Michigan  48075-9975
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
CCOP - NorthwestTacoma, Washington  98405-0986
CCOP - Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Oregon Cancer Center at Oregon Health Sciences UniversityPortland, Oregon  97201-3098
Puget Sound Oncology ConsortiumSeattle, Washington  98109
Saint Mary Medical Center - Long BeachLong Beach, California  90813-0887
Kaiser Permanente Medical Center - VallejoVallejo, California  94589
Hartford HospitalHartford, Connecticut  06102-5037
Winship Cancer InstituteAtlanta, Georgia  30322
Medical College of Georgia Comprehensive Cancer CenterAugusta, Georgia  30912-4000
Illinois Masonic Medical CenterChicago, Illinois  60657
Rockford ClinicRockford, Illinois  61103
Lucille Parker Markey Cancer Center, University of KentuckyLexington, Kentucky  40536-0093
Norton Healthcare SystemLouisville, Kentucky  40202-5070
Louisiana State University Medical Center - New OrleansNew Orleans, Louisiana  70112
Eastern Maine Medical CenterBangor, Maine  04401
Franklin Square Hospital CenterBaltimore, Maryland  21237
Regional Cancer Therapy Center - FrederickFrederick, Maryland  21701
Lahey Clinic - BurlingtonBurlington, Massachusetts  01805
Berkshire Medical CenterPittsfield, Massachusetts  01201
Baystate Medical CenterSpringfield, Massachusetts  01199
Michigan State UniversityEast Lansing, Michigan  48824
St. Louis University School of MedicineSaint Louis, Missouri  63104
University of New Mexico Cancer Research & Treatment CenterAlbuquerque, New Mexico  87131
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Aultman Cancer CenterCanton, Ohio  44710
Jewish Hospital of Cincinnati, Inc.Cincinnati, Ohio  45236
South Pointe HospitalCleveland, Ohio  44122
St. Luke's Network - BethlehemBethlehem, Pennsylvania  18015
Allegheny General HospitalPittsburgh, Pennsylvania  15212-4772
Medical Group of TexasDallas, Texas  75243
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Eastern Virginia Medical SchoolNorfolk, Virginia  23507
Camden-Clark Memorial HospitalParkersburg, West Virginia  26102
Trinitas Hospital - Jersey Street CampusElizabeth, New Jersey  07201
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Hackensack University Medical CenterHackensack, New Jersey  07601
West Virginia University HospitalsMorgantown, West Virginia  26506-9300
Cooper Cancer InstituteCamden, New Jersey  08103
University of Connecticut Health CenterFarmington, Connecticut  06360-7106
CCOP - Sooner StateTulsa, Oklahoma  74136
Overlook HospitalSummit, New Jersey  07902-0220
Comprehensive Cancer Centers of the DesertPalm Springs, California  92262
Kaiser Permanente-Southern California Permanente Medical GroupSan Diego, California  92120
Catholic Healthcare West - Westbay RegionSan Francisco, California  94107-1728
George Washington University Cancer CenterWashington, District of Columbia  20037
Good Samaritan Medical CenterWest Palm Beach, Florida  33401
North Idaho Cancer CenterCoeur d'Alene, Idaho  83814
Cancer Institute of New Jersey at HamiltonHamilton, New Jersey  08690
University of Medicine and Dentistry of New JerseyNewark, New Jersey  07103-2425
Kent County Memorial Hospital - Rhode IslandWarwick, Rhode Island  02886
Virginia Oncology AssociatesNewport News, Virginia  23606
David Lee Cancer CenterCharleston, West Virginia  25304