Chemotherapy in Treating Women With Breast Cancer That Can Be Surgically Removed

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

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 if chemotherapy given before surgery is more effective with or without docetaxel given before or after surgery for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy using doxorubicin and cyclophosphamide with or without docetaxel in treating women who have stage II or stage III breast cancer.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Doxorubicin; Drug: Tamoxifen

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 2411
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Center - Calgary
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • CancerCare Manitoba
  • Ontario
    • Mississauga, Ontario, Canada, L5M 2N1
      • Credit Valley Hospital
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • Montreal General Hospital
    • Montreal, Quebec, Canada, H3A 1A1
      • Royal Victoria Hospital - Montreal
    • Montreal, Quebec, Canada, H2L-4M1
      • Centre Hospitalier de l'Universite de Montreal
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital - Montreal
    • Montreal, Quebec, Canada, H3T 1M5
      • St. Mary's Hospital Center
    • Quebec City, Quebec, Canada, G1S 4L8
      • Hopital du Saint-Sacrament, Quebec
    • Ste-Foy, Quebec, Canada, G1V 4G5
      • L'Hopital Laval
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Huntsville Hospital System
  • Arizona
    • Phoenix, Arizona, United States, 85006-2726
      • CCOP - Greater Phoenix
  • California
    • Greenbrae, California, United States, 94904
      • Sutter Health Western Division Cancer Research Group
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
    • Long Beach, California, United States, 90813-0887
      • Saint Mary Medical Center - Long Beach
    • Los Angeles, California, United States, 91010
      • Beckman Research Institute, City of Hope
    • Oakland, California, United States, 94609-3305
      • CCOP - Bay Area Tumor Institute
    • Orange, California, United States, 92868
      • Chao Family Comprehensive Cancer Center
    • Palm Springs, California, United States, 92262
      • Comprehensive Cancer Centers of the Desert
    • San Diego, California, United States, 92120
      • Kaiser Permanente-Southern California Permanente Medical Group
    • San Francisco, California, United States, 94107-1728
      • Catholic Healthcare West - Westbay Region
    • Santa Rosa, California, United States, 95403
      • CCOP - Santa Rosa Memorial Hospital
    • Vallejo, California, United States, 94589
      • Kaiser Permanente Medical Center - Vallejo
  • Colorado
    • Denver, Colorado, United States, 80262
      • University of Colorado Cancer Center
    • Denver, Colorado, United States, 80209-5031
      • CCOP - Colorado Cancer Research Program, Inc.
  • Connecticut
    • Farmington, Connecticut, United States, 06360-7106
      • University of Connecticut Health Center
    • Hartford, Connecticut, United States, 06102-5037
      • Hartford Hospital
  • Delaware
    • Wilmington, Delaware, United States, 19899
      • CCOP - Christiana Care Health Services
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University Cancer Center
  • Florida
    • Daytona Beach, Florida, United States, 32114
      • Halifax Medical Center
    • Jacksonville, Florida, United States, 32207
      • Baptist Regional Cancer Institute - Jacksonville
    • Miami, Florida, United States, 33136
      • Sylvester Cancer Center, University of Miami
    • Miami Beach, Florida, United States, 33140
      • CCOP - Mount Sinai Medical Center
    • West Palm Beach, Florida, United States, 33401
      • Good Samaritan Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30342-1701
      • CCOP - Atlanta Regional
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute
    • Augusta, Georgia, United States, 30912-4000
      • Medical College of Georgia Comprehensive Cancer Center
    • Fort Gordon, Georgia, United States, 30905-5650
      • Dwight David Eisenhower Army Medical Center
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Cancer Research Center of Hawaii
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • North Idaho Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60657
      • Illinois Masonic Medical Center
    • Evanston, Illinois, United States, 60201
      • CCOP - Evanston
    • Peoria, Illinois, United States, 61602
      • CCOP - Illinois Oncology Research Association
    • Rockford, Illinois, United States, 61103
      • Rockford Clinic
    • Urbana, Illinois, United States, 61801
      • CCOP - Carle Cancer Center
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • St. Vincent Hospital and Health Care Center
    • South Bend, Indiana, United States, 46601
      • Memorial Hospital of South Bend
  • Iowa
    • Des Moines, Iowa, United States, 50309-1016
      • CCOP - Iowa Oncology Research Association
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Kansas
    • Wichita, Kansas, United States, 67214-3882
      • CCOP - Wichita
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0093
      • Lucille Parker Markey Cancer Center, University of Kentucky
    • Louisville, Kentucky, United States, 40202-5070
      • Norton Healthcare System
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University School of Medicine
    • New Orleans, Louisiana, United States, 70121
      • CCOP - Ochsner
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University Medical Center - New Orleans
  • Maine
    • Bangor, Maine, United States, 04401
      • Eastern Maine Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Franklin Square Hospital Center
    • Bethesda, Maryland, United States, 20889-5000
      • National Naval Medical Center
    • Frederick, Maryland, United States, 21701
      • Regional Cancer Therapy Center - Frederick
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic - Burlington
    • Pittsfield, Massachusetts, United States, 01201
      • Berkshire Medical Center
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • CCOP - Ann Arbor Regional
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • East Lansing, Michigan, United States, 48824
      • Michigan State University
    • Grand Rapids, Michigan, United States, 49503
      • CCOP - Grand Rapids Clinical Oncology Program
    • Kalamazoo, Michigan, United States, 49007-3731
      • CCOP - Kalamazoo
    • Southfield, Michigan, United States, 48075-9975
      • Providence Hospital - Southfield
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • CCOP - Duluth
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center - Minneapolis
  • Mississippi
    • Jackson, Mississippi, United States, 39216-4505
      • University of Mississippi Medical Center
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Ellis Fischel Cancer Center - Columbia
    • Saint Louis, Missouri, United States, 63141
      • CCOP - St. Louis-Cape Girardeau
    • Saint Louis, Missouri, United States, 63104
      • St. Louis University School of Medicine
    • Springfield, Missouri, United States, 65807
      • CCOP - Cancer Research for the Ozarks
  • Montana
    • Billings, Montana, United States, 59101
      • CCOP - Montana Cancer Consortium
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Methodist Cancer Center - Omaha
    • Omaha, Nebraska, United States, 68131
      • CCOP - Missouri Valley Cancer Consortium
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • CCOP - Southern Nevada Cancer Research Foundation
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper Cancer Institute
    • Elizabeth, New Jersey, United States, 07201
      • Trinitas Hospital - Jersey Street Campus
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
    • Hackensack, New Jersey, United States, 07601
      • CCOP - Northern New Jersey
    • Hamilton, New Jersey, United States, 08690
      • Cancer Institute of New Jersey at Hamilton
    • New Brunswick, New Jersey, United States, 08901
      • Cancer Institute Of New Jersey
    • Newark, New Jersey, United States, 07112
      • Newark Beth Israel Medical Center
    • Newark, New Jersey, United States, 07103-2425
      • University of Medicine and Dentistry of New Jersey
    • Summit, New Jersey, United States, 07902-0220
      • Overlook Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico Cancer Research & Treatment Center
  • New York
    • Syracuse, New York, United States, 13210
      • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7295
      • Lineberger Comprehensive Cancer Center, UNC
    • Greenville, North Carolina, United States, 27858-4354
      • East Carolina University School of Medicine
    • Winston-Salem, North Carolina, United States, 27104-4241
      • CCOP - Southeast Cancer Control Consortium
    • Winston-Salem, North Carolina, United States, 27157-1082
      • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
  • North Dakota
    • Fargo, North Dakota, United States, 58122
      • CCOP - Merit Care Hospital
  • Ohio
    • Akron, Ohio, United States, 44309
      • Akron City Hospital
    • Canton, Ohio, United States, 44710
      • Aultman Cancer Center
    • Cincinnati, Ohio, United States, 45219
      • Barrett Cancer Center, The University Hospital
    • Cincinnati, Ohio, United States, 45236
      • Jewish Hospital of Cincinnati, Inc.
    • Cleveland, Ohio, United States, 44122
      • South Pointe Hospital
    • Columbus, Ohio, United States, 43206
      • CCOP - Columbus
    • Columbus, Ohio, United States, 43210
      • Arthur G. James Cancer Hospital - Ohio State University
    • Kettering, Ohio, United States, 45429
      • CCOP - Dayton
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • CCOP - Sooner State
  • Oregon
    • Portland, Oregon, United States, 97201-3098
      • Oregon Cancer Center at Oregon Health Sciences University
    • Portland, Oregon, United States, 97213
      • CCOP - Columbia River Program
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18105-1556
      • Lehigh Valley Hospital
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's Network - Bethlehem
    • Danville, Pennsylvania, United States, 17822-2001
      • Geisinger Medical Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Cancer Institute
    • Pittsburgh, Pennsylvania, United States, 15212-4772
      • Allegheny General Hospital
    • Scranton, Pennsylvania, United States, 18501
      • Mercy Hospital Cancer Center - Scranton
    • Wynnewood, Pennsylvania, United States, 19096
      • CCOP - MainLine Health
    • York, Pennsylvania, United States, 17315
      • York Hospital
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Kent County Memorial Hospital - Rhode Island
  • South Carolina
    • Charleston, South Carolina, United States, 29425-0721
      • Medical University of South Carolina
    • Greenville, South Carolina, United States, 29615
      • CCOP - Greenville
    • Spartanburg, South Carolina, United States, 29303
      • CCOP - Upstate Carolina
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105-1080
      • CCOP - Sioux Community Cancer Consortium
  • Tennessee
    • Memphis, Tennessee, United States, 38117
      • CCOP - Baptist Cancer Institute
  • Texas
    • Dallas, Texas, United States, 75235-9154
      • Simmons Cancer Center - Dallas
    • Dallas, Texas, United States, 75243
      • Medical Group of Texas
    • Galveston, Texas, United States, 77555-1329
      • University of Texas Medical Branch
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Lubbock, Texas, United States, 79410-1894
      • Joe Arrington Cancer Research and Treatment Center
    • San Antonio, Texas, United States, 78284-7811
      • University of Texas Health Science Center at San Antonio
    • Temple, Texas, United States, 76508
      • CCOP - Scott and White Hospital
  • Utah
    • Provo, Utah, United States, 84604
      • Utah Valley Regional Medical Center - Provo
  • Vermont
    • Bennington, Vermont, United States, 05201
      • CCOP - Southwestern Vermont Regional Cancer Center
    • Burlington, Vermont, United States, 05401-3498
      • Vermont Cancer Center
  • Virginia
    • Newport News, Virginia, United States, 23606
      • Virginia Oncology Associates
    • Norfolk, Virginia, United States, 23507
      • Eastern Virginia Medical School
    • Richmond, Virginia, United States, 23298-0037
      • MBCCOP - Massey Cancer Center
  • Washington
    • Seattle, Washington, United States, 98101
      • CCOP - Virginia Mason Research Center
    • Seattle, Washington, United States, 98109
      • Puget Sound Oncology Consortium
    • Tacoma, Washington, United States, 98405-0986
      • CCOP - Northwest
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • David Lee Cancer Center
    • Morgantown, West Virginia, United States, 26506-9162
      • West Virginia University Hospitals
    • Parkersburg, West Virginia, United States, 26102
      • Camden-Clark Memorial Hospital
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54307-3508
      • St. Vincent Hospital
    • Marshfield, Wisconsin, United States, 54449
      • CCOP - Marshfield Medical Research and Education Foundation
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • St. Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 2; doxorubicin and cyclophosphamide plus Taxotere prior to surgery plus tamoxifen	Drug: Cyclophosphamide; 600 mg/m2 IV every 21 days for 4 cycles; Drug: Docetaxel; 100 mg/m2 IV every 21 days for 4 cycles; Drug: Doxorubicin; 60 mg/m2 IV every 21 days fo 4 cycles; Drug: Tamoxifen; 20 mg p.o. once daily for 5 years starting on day 1 of ther first AC cycle
Experimental: Group 3; doxorubicin and cyclophosphamide followed by surgery followed by taxotere plus tamoxifen	Drug: Cyclophosphamide; 600 mg/m2 IV every 21 days for 4 cycles; Drug: Docetaxel; 100 mg/m2 IV every 21 days for 4 cycles; Drug: Doxorubicin; 60 mg/m2 IV every 21 days fo 4 cycles; Drug: Tamoxifen; 20 mg p.o. once daily for 5 years starting on day 1 of ther first AC cycle
Active Comparator: Group 1; doxorubicin and cyclophosphamide plus tamoxifen	Drug: Cyclophosphamide; 600 mg/m2 IV every 21 days for 4 cycles; Drug: Doxorubicin; 60 mg/m2 IV every 21 days fo 4 cycles; Drug: Tamoxifen; 20 mg p.o. once daily for 5 years starting on day 1 of ther first AC cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	Time from randomization to death from any cause.

Secondary Outcome Measures

Outcome Measure	Time Frame
Prolonging disease-free survival (DFS).	Time from randomization to first related event of inoperable disease; residual disease following surgery; local, regional or distant recurrence; second primary cancer; death from any cause other than cancer.
Clinical loco-regional tumor response to preoperative chemotherapy.	3-4 weeks after the last cycle of pre-op chemotherapy.
Pathologic loco-regional tumor response to pre-op chemotherapy.	At time of surgery.
Breast conservation assessment.	Assessed following surgery.
Evaluate if post-op Taxotere is of benefit in patients who received pre-op AC and, if so, whether it is of benefit in certain subgroups of patients.	DFS and S will be assessed in patient subgroups.

Collaborators and Investigators

• Sponsor: NSABP Foundation Inc
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Harry D. Bear, MD, PhD, Massey Cancer Center

Publications and helpful links

General Publications

• Rastogi P, Anderson SJ, Bear HD, Geyer CE, Kahlenberg MS, Robidoux A, Margolese RG, Hoehn JL, Vogel VG, Dakhil SR, Tamkus D, King KM, Pajon ER, Wright MJ, Robert J, Paik S, Mamounas EP, Wolmark N. Preoperative chemotherapy: updates of National Surgical Adjuvant Breast and Bowel Project Protocols B-18 and B-27. J Clin Oncol. 2008 Feb 10;26(5):778-85. doi: 10.1200/JCO.2007.15.0235. Erratum In: J Clin Oncol. 2008 Jun 1;26(16):2793.
• Soran A, Nesbitt L, Mamounas EP, Lembersky B, Bryant J, Anderson S, Brown A, Passarello M. Centralized medical monitoring in phase III clinical trials: the National Surgical Adjuvant Breast and Bowel Project (NSABP) experience. Clin Trials. 2006;3(5):478-85. doi: 10.1177/1740774506070747.
• Heys SD, Sarkar T, Hutcheon AW. Primary docetaxel chemotherapy in patients with breast cancer: impact on response and survival. Breast Cancer Res Treat. 2005 Mar;90(2):169-85. doi: 10.1007/s10549-004-1001-0.
• Bear HD, Anderson S, Smith RE, Geyer CE Jr, Mamounas EP, Fisher B, Brown AM, Robidoux A, Margolese R, Kahlenberg MS, Paik S, Soran A, Wickerham DL, Wolmark N. Sequential preoperative or postoperative docetaxel added to preoperative doxorubicin plus cyclophosphamide for operable breast cancer:National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2006 May 1;24(13):2019-27. doi: 10.1200/JCO.2005.04.1665. Epub 2006 Apr 10.
• Julian T, Anderson S, Fourchotte V, et al.: Is invasive lobular breast cancer a prognostic factor for neoadjuvant chemotherapy response and long term outcomes? [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-3065, S146, 2006.
• Mamounas EP, Brown A, Anderson S, Smith R, Julian T, Miller B, Bear HD, Caldwell CB, Walker AP, Mikkelson WM, Stauffer JS, Robidoux A, Theoret H, Soran A, Fisher B, Wickerham DL, Wolmark N. Sentinel node biopsy after neoadjuvant chemotherapy in breast cancer: results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2005 Apr 20;23(12):2694-702. doi: 10.1200/JCO.2005.05.188. Erratum In: J Clin Oncol. 2005 Jul 20;23(21):4808. Sovan, Atilla [corrected to Soran, Atilla].
• Bear HD, Anderson S, Smith RE, et al.: A randomized trial comparing preoperative (preop) doxorubicin/cyclophosphamide (AC) to preop AC followed by preop docetaxel (T) and to preop AC followed by postoperative (postop) T in patients (pts) with operable carcinoma of the breast: results of NSABP B-27. [Abstract] Breast Cancer Res Treat 88 (Suppl 1): A-26, 2004.
• Bear HD, Anderson S, Brown A, Smith R, Mamounas EP, Fisher B, Margolese R, Theoret H, Soran A, Wickerham DL, Wolmark N; National Surgical Adjuvant Breast and Bowel Project Protocol B-27. The effect on tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2003 Nov 15;21(22):4165-74. doi: 10.1200/JCO.2003.12.005. Epub 2003 Oct 14.
• Mamounas EP, Brown A, Smith R, et al.: Accuracy of sentinel node biopsy after neoadjuvant chemotherapy in breast cancer: updated results from NSABP B-27. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-140, 2002.

Study record dates

Study Major Dates

• Study Start: December 1, 1995
• Primary Completion (Actual): June 1, 2002
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: November 1, 1999
• First Submitted That Met QC Criteria: May 20, 2004
• First Posted (Estimate): May 21, 2004

Study Record Updates

• Last Update Posted (Estimate): February 3, 2010
• Last Update Submitted That Met QC Criteria: February 2, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: stage IIIA breast cancer; stage II breast cancer; stage I breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Hormone Antagonists; Bone Density Conservation Agents; Estrogen Antagonists; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Docetaxel; Cyclophosphamide; Doxorubicin; Tamoxifen
• Other Study ID Numbers: NSABP B-27; CDR0000064521