AzTrials
AzTrials

Breast CancerPhase 3NCT00003782

Combination Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA (cT1-3, N0-1, M0) Breast Cancer and Positive Axillary Lymph Nodes

A Phase 3 study testing cyclophosphamide, docetaxel and doxorubicin in people with Breast Cancer, run by NSABP Foundation Inc at 157 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy after surgery may kill any tumor cells remaining following surgery. Read more about this study

Who is it for?
Ages 18 to 120 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
cyclophosphamide, docetaxel and doxorubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,351 participants
Where
157 sitesin 2 countries
Study dates
Mar 1999to Dec 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive adenocarcinoma of the breast
  • Confined to the breast and ipsilateral axilla on clinical exam
  • Stage I, II, or IIIA (cT1-3, N0-1, M0)
  • At least one axillary lymph node with evidence of tumor on histologic exam
  • Sentinel node biopsy allowed if followed by axillary dissection
  • No suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless proven on biopsy to not be involved with tumor
  • No bilateral malignancy or mass in the opposite breast, unless mass is histologically proven to be benign
  • Must have undergone either a prior total mastectomy and axillary dissection (modified radical mastectomy) OR
  • Prior lumpectomy and axillary dissection
  • Patients must receive radiotherapy after randomization (not before) AND after chemotherapy
  • Margins must be clear
  • No ipsilateral lymph nodes that are fixed to one another or to other structures (N2 disease) and/or any positive nonaxillary lymph nodes (intramammary nodes are considered axillary nodes)
  • No histologically evident invasive tumor or ductal carcinoma in situ
  • No diffuse tumors by mammography that would not be surgically amenable to lumpectomy
  • No other dominant mass in the ipsilateral breast remnant unless one of the following is true:
  • Histologically benign
  • Surgically removed with clear margins if malignant
  • No ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude
  • Tethering or dimpling of the skin or nipple inversion allowed
  • No metastatic disease
  • Skeletal pain allowed if bone scan negative for metastases
  • Hormone receptor status:
  • Estrogen and progesterone status determined

PATIENT CHARACTERISTICS:

Age:

  • greater than or equal to 18 years

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • At least 10 years, excluding diagnosis of cancer

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3 (may be less, if in the opinion of the investigator, this represents an ethnic or racial variation)
  • Platelet count at least 100,000/mm^3* NOTE: *If platelet count is above the upper limit of normal (ULN), significant underlying hematologic disorders must be excluded

Hepatic:

  • Bilirubin no greater than ULN
  • Alkaline phosphatase less than 2.5 times ULN*
  • SGOT less than 1.5 times ULN*
  • No nonmalignant systemic hepatic disease that would preclude study participation NOTE: *Alkaline phosphatase and SGOT cannot both be greater than ULN

Renal:

  • Creatinine no greater than normal
  • No nonmalignant systemic renal disease that would preclude study participation

Cardiovascular:

  • No nonmalignant systemic cardiovascular disease that would preclude study participation
  • LVEF at least lower limit of normal (LLN) by MUGA or echocardiogram
  • No active cardiac disease that would preclude use of doxorubicin or docetaxel, including the following:
  • Any prior myocardial infarction
  • Angina pectoris requiring anti-anginal medication
  • History of congestive heart failure
  • Cardiac arrhythmia requiring medication
  • Severe conduction abnormality
  • Valvular disease with documented cardiac function compromise
  • Cardiomegaly on chest x-ray or ventricular hypertrophy on EKG, unless LVEF at least LLN
  • Poorly controlled hypertension (diastolic greater than 100 mm/Hg)
  • Hypertension well controlled by medication allowed

Other:

  • No grade 2 or greater peripheral neuropathy
  • No other prior malignancy within the past 5 years except:
  • Effectively treated squamous cell or basal cell skin cancer
  • Surgically treated carcinoma in situ of the cervix
  • Segmentally resected lobular carcinoma in situ of the ipsilateral or contralateral breast
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception
  • No nonmalignant systemic disease that would preclude study participation
  • No diabetes with morning fasting blood glucose of 200 mg/dL or greater
  • No psychiatric or addictive disorders that would preclude informed consent
  • No contraindication to corticosteroids that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy for breast cancer

Chemotherapy:

  • No prior chemotherapy for breast cancer
  • No prior anthracyclines or taxanes
  • No other concurrent investigational chemotherapy

Endocrine therapy:

  • No prior hormonal therapy for breast cancer
  • No concurrent hormonal birth control methods or other hormonal therapy
  • No concurrent raloxifene, including for osteoporosis
  • Concurrent low-dose topical estrogen in the form of conjugated estrogen ring or conjugated estrogen vaginal cream (dose no more than 0.3 mg or 1/8 of an applicator applied vaginally 3 times a week) allowed

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy for this malignancy

Surgery:

  • See Disease Characteristics
  • No more than 84 days since prior surgery for breast cancer (e.g., lumpectomy, mastectomy, sentinel node biopsy, axillary dissection, or re-excision of lumpectomy margins)

Other:

  • No prior systemic therapy for this malignancy
  • No concurrent medications that alter cardiac conduction (e.g., digitalis, beta blockers, or calcium-channel blockers) for cardiac arrhythmia, angina, or congestive heart failure (allowed if administered for other reasons [e.g., hypertension])
  • Concurrent bisphosphonates allowed

Trial locations and contacts

157 sites in 2 countries.

157 sites in 2 countries

United States146 sites

  • Akron City Hospital

    Akron, Ohio, 44309

  • New York Oncology Hematology, P.C. - Albany Regional Cancer Center

    Albany, New York, 12208

  • MBCCOP - University of New Mexico HSC

    Albuquerque, New Mexico, 87131

  • John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99519-6604

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342-1701

  • Medical College of Georgia Comprehensive Cancer Center

    Augusta, Georgia, 30912-4000

  • Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Green Mountain Oncology Group

    Bennington, Vermont, 05201

  • National Naval Medical Center

    Bethesda, Maryland, 20889-5000

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Cancer Research Center at Boston Medical Center

    Boston, Massachusetts, 02118

  • Lahey Clinic Medical Center - Burlington

    Burlington, Massachusetts, 01805

  • Alamance Cancer Center

    Burlington, North Carolina, 27216

  • Aultman Hospital Cancer Center at Aultman Health Foundation

    Canton, Ohio, 44710

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

  • Charleston Area Medical Center

    Charleston, West Virginia, 25304-1297

  • John H. Stroger, Jr. Hospital of Cook County

    Chicago, Illinois, 60612-9985

  • Rush-Presbyterian-St. Luke's Medical Center

    Chicago, Illinois, 60612

  • Creticos Cancer Center at Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Jewish Hospital of Cincinnati, Incorporated

    Cincinnati, Ohio, 45236

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267-0502

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • North Idaho Cancer Center

    Coeur d'Alene, Idaho, 83814

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210-1240

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 75235-9154

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-2001

  • Genesis Medical Center

    Davenport, Iowa, 52804

  • Halifax Medical Center

    Daytona Beach, Florida, 32114

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • University of Colorado Cancer Center at University of Colorado Health Sciences Center

    Denver, Colorado, 80010

  • CCOP - Colorado Cancer Research Program, Incorporated

    Denver, Colorado, 80209-5031

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309-1016

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Michigan State University

    East Lansing, Michigan, 48824

  • CCOP - Evanston

    Evanston, Illinois, 60201

  • CCOP - Merit Care Hospital

    Fargo, North Dakota, 58122

  • University of Connecticut Cancer Center at University of Connecticut Health Center

    Farmington, Connecticut, 06360-7106

  • Dwight David Eisenhower Army Medical Center

    Fort Gordon, Georgia, 30905-5650

  • California Cancer Center

    Fresno, California, 93720

  • Charles R. Wood Foundation Cancer Center at Glens Falls Hospital

    Glens Falls, New York, 12801

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • CCOP - St. Vincent Hospital Cancer Center, Green Bay

    Green Bay, Wisconsin, 54301

  • Sutter Health Western Division Cancer Research Group

    Greenbrae, California, 94904

  • Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina

    Greenville, North Carolina, 27858-4354

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • CCOP - Northern New Jersey

    Hackensack, New Jersey, 07601

  • Hartford Hospital

    Hartford, Connecticut, 06102-5037

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Comprehensive Cancer Institute

    Huntsville, Alabama, 35801

  • Methodist Cancer Center at Methodist Hospital

    Indianapolis, Indiana, 46206-1367

  • St. Vincent Hospital and Health Care Center

    Indianapolis, Indiana, 46260

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1009

  • Baptist Regional Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • CCOP - Dayton

    Kettering, Ohio, 45429

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • Scripps Cancer Center at Scripps Clinic

    La Jolla, California, 92037

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Markey Cancer Center at University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536-0093

  • Loma Linda University Cancer Institute at Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • Norton Healthcare Cancer Center

    Louisville, Kentucky, 40202-5070

  • Consultants in Blood Disorders and Cancer

    Louisville, Kentucky, 40207

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410-1894

  • CCOP - Marshfield Clinic Research Foundation

    Marshfield, Wisconsin, 54449

  • Baptist Cancer Institute - Memphis at Baptist Memorial Hospital - Memphis

    Memphis, Tennessee, 38146

  • University of Miami Sylvester Cancer Center

    Miami, Florida, 33136

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • Community Hospital

    Munster, Indiana, 46321

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans

    New Orleans, Louisiana, 70112

  • Tulane University Medical Center

    New Orleans, Louisiana, 70112

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Virginia Oncology Associates - Newport News

    Newport News, Virginia, 23606

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23507

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609-3305

  • Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha

    Omaha, Nebraska, 68114

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68131

  • Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center

    Orange, California, 92868

  • MD Anderson Cancer Center Orlando

    Orlando, Florida, 32806

  • Comprehensive Cancer Centers of the Desert

    Palm Springs, California, 92262

  • Stanford Cancer Center at Stanford University Medical Center

    Palo Alto, California, 94305-5408

  • Camden-Clark Memorial Hospital

    Parkersburg, West Virginia, 26102

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61602

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania, 19141

  • CCOP - Western Regional, Arizona

    Phoenix, Arizona, 85006-2726

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212-4772

  • Hillman Cancer Center at University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15213-3489

  • Berkshire Medical Center

    Pittsfield, Massachusetts, 01201

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97213

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • MBCCOP - Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Oncology and Hematology Associates of Southwest Virginia, Inc.

    Roanoke, Virginia, 24014

  • CCOP - Beaumont

    Royal Oak, Michigan, 48073-6769

  • Sutter Cancer Center

    Sacramento, California, 95816

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78284-7811

  • Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego

    San Diego, California, 92120

  • Catholic Healthcare West - Westbay Region

    San Francisco, California, 94107-1728

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California, 95403

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Mercy Hospital Cancer Center - Scranton

    Scranton, Pennsylvania, 18501

  • CCOP - Virginia Mason Research Center

    Seattle, Washington, 98101

  • Puget Sound Oncology Consortium

    Seattle, Washington, 98109

  • Providence Cancer Institute at Providence Hospital

    Southfield, Michigan, 48075-9975

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • St. Louis University Hospital Cancer Center

    St Louis, Missouri, 63110-0250

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • Staten Island University Hospital

    Staten Island, New York, 10305

  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

    Syracuse, New York, 13217

  • CCOP - Northwest

    Tacoma, Washington, 98405-0986

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Lincoln Medical and Mental Health Center

    The Bronx, New York, 10451

  • MBCCOP-Our Lady of Mercy Cancer Center

    The Bronx, New York, 10466

  • CCOP - Toledo Community Hospital

    Toledo, Ohio, 43623-3456

  • CCOP - Oklahoma

    Tulsa, Oklahoma, 74136

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Kaiser Permanente Medical Center - Vallejo

    Vallejo, California, 94589

  • South Pointe Hospital - Cancer Care Center

    Warrensville Heights, Ohio, 44122

  • MBCCOP - Howard University Cancer Center

    Washington D.C., District of Columbia, 20060

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

  • CCOP - Christiana Care Health Services

    Wilmington, Delaware, 19899

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina, 27104-4241

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1082

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania, 19096

  • Wellspan Health - York Cancer Center

    York, Pennsylvania, 17315

Other trials in United States

Canada11 sites

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

  • Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2L-4M1

  • Royal Victoria Hospital - Montreal

    Montreal, Quebec, H3A 1A1

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • Jewish General Hospital - Montreal

    Montreal, Quebec, H3T 1E2

  • St. Mary's Hospital Center

    Montreal, Quebec, H3T 1M5

  • Ottawa Regional Cancer Centre

    Ottawa, Ontario, K1H 1C4

  • Hopital du Saint-Sacrement, Quebec

    Québec, Quebec, G1S 4L8

  • St. Michael's Hospital - Toronto

    Toronto, Ontario, M5B 1W8

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

Official title: A Three-Arm Randomized Trial to Compare Adjuvant Adriamycin and Cyclophosphamide Followed by Taxotere (AC-T); Adriamycin and Taxotere (AT); and Adriamycin, Taxotere, and Cyclophosphamide (ATC) in Breast Cancer Patients With Positive Axillary Lymph Nodes

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy after surgery may kill any tumor cells remaining following surgery. It is not yet known which regimen of combination chemotherapy is more effective in treating breast cancer with positive axillary lymph nodes.

PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy in treating women who have undergone surgery for stage I, stage II, or stage IIIA breast cancer with positive axillary lymph nodes.

Read the detailed description

OBJECTIVES:

  • Compare the efficacy of adjuvant doxorubicin, cyclophosphamide, and docetaxel given concurrently vs adjuvant doxorubicin and cyclophosphamide followed by docetaxel, in terms of overall survival and disease-free survival, of women with breast cancer and positive axillary lymph nodes.
  • Compare the efficacy of adjuvant doxorubicin and docetaxel vs regimens containing cyclophosphamide in these patients.
  • Compare the toxic effects of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens. (Quality of life substudy closed to accrual as of 7/20/01.)
  • Compare the differences in amenorrhea in premenopausal women in each treatment arm and its relationship to symptoms, quality of life (quality of life substudy closed to accrual as of 7/20/01), disease-free survival, and overall survival.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, number of positive nodes (1-3 vs 4-9 vs at least 10), sequential tamoxifen or anastrozole administration (yes vs no), and type of prior surgery and radiotherapy plan (mastectomy with no local or regional radiotherapy vs mastectomy with local and/or regional radiotherapy vs lumpectomy with local radiotherapy vs lumpectomy with local and regional radiotherapy). Patients are randomized to one of three treatment arms.

  • Arm 1: Patients receive doxorubicin IV over 15 minutes and cyclophosphamide IV over 30 minutes every 21 days for 4 courses. Three weeks after the last dose of this combination, patients receive docetaxel IV over 1 hour every 21 days for 4 courses.
  • Arm 2: Patients receive doxorubicin IV over 15 minutes and docetaxel IV over 1 hour every 21 days for 4 courses.
  • Arm 3: Patients receive doxorubicin IV over 15 minutes, cyclophosphamide IV over 30 minutes, and docetaxel IV over 1 hour every 21 days for 4 courses.

Patients in all arms who are estrogen receptor-positive and/or progesterone receptor-positive receive oral tamoxifen daily for 5 years beginning within 3-12 weeks of completion of chemotherapy. Patients who are postmenopausal may receive alternative hormonal therapy at the discretion of the treating physician.

Some patients may receive postmastectomy radiotherapy on SWOG-S9927 or NCIC-MA.20 after recovery from chemotherapy.

Quality of life and menstrual history are assessed before randomization, on day 1 of course 4, and at 6, 12, 18, and 24 months. (Quality of life substudy closed to accrual as of 7/20/01.)

Patients are followed every 6 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 5,300 patients will be accrued for this study within 4-5 years.

Conditions
Breast Cancer
Keywords
stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cyclophosphamideDrug

    Arm 1: 600 mg/m2 IV every 21 days for 4 cycles; Arm 3: 500 mg/m2 IV every 21 days for 4 cycles

  • docetaxelDrug

    Also called Taxotere

    Arm 1: 100 mg/m2 IV every 21 days for 4 cycles; Arms 2 and 3: 75 mg/m2 IV every 21 days for 4 cycles

  • doxorubicinDrug

    Also called Adriamycin

    Arm 1: 60 mg/m2 IV every 21 days for 4 cycles; Arms 2 and 3: 50 mg/m2 IV every 21 days for 4 cycles

Study groups in NCT00003782
Study groupRoleWhat they receive
Arm 1: Doxorubicin + Cyclophosphamide, then DocetaxelExperimentalDoxorubicin + Cyclophosphamide, then Docetaxel
Receives: Drug: cyclophosphamide; Drug: docetaxel; Drug: doxorubicin
Arm 2: Doxorubicin + DocetaxelExperimentalDoxorubicin + Docetaxel
Receives: Drug: docetaxel; Drug: doxorubicin
Arm 3: Doxorubicin + Docetaxel + CyclophosphamideExperimentalDoxorubicin + Docetaxel + Cyclophosphamide
Receives: Drug: cyclophosphamide; Drug: docetaxel; Drug: doxorubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Measured: 8 years

  2. Disease Free Survival

    Measured: time to event: breast cancer recurrence; second primary cancer; death from any cause as a first event

Secondary outcomes (3)

  1. Toxicities Among the 3 Regimens

    Measured: 9 years

  2. Quality of Life Among Breast Cancer Patients

    Measured: baseline, 9 weeks, and 6, 12, 18, and 24 months

  3. Amenorrhea in Premenopausal Women

    Measured: baseline, 9 weeks, and 6, 12, 18, and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startMar 1999
  3. Primary completionDec 2008
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5,351 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003782
Sponsor's protocol ID
NSABP B-30
Other IDs
CDR0000066914
Status last verified
Mar 2024
First submitted
1 Nov 1999
Last updated
21 Mar 2024
Data monitoring committee
Yes

Publications

  • Swain SM, Land SR, Ritter MW, Costantino JP, Cecchini RS, Mamounas EP, Wolmark N, Ganz PA. Amenorrhea in premenopausal women on the doxorubicin-and-cyclophosphamide-followed-by-docetaxel arm of NSABP B-30 trial. Breast Cancer Res Treat. 2009 Jan;113(2):315-20. doi: 10.1007/s10549-008-9937-0. Epub 2008 Feb 27.

    PubMed 18302020

  • Ganz PA, Land SR, Geyer CE, et al.: NSABP B-30: definitive analysis of quality of life (QOL) and menstrual history (MH) outcomes from a randomized trial evaluating different schedules and combinations of adjuvant therapy containing doxorubicin, docetaxel and cyclophosphamide in women with operable, node-positive breast cancer. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-76, 2008.

  • Swain SM, Jeong JH, Geyer CE, et al.: NSABP B-30: definitive analysis of patient outcome from a randomized trial evaluating different schedules and combinations of adjuvant therapy containing doxorubicin, docetaxel and cyclophosphamide in women with operable, node-positive breast cancer. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-75, 2008.

  • Swain SM, Land SR, Sundry R, et al.: Amenorrhea in premenopausal women on the doxorubicin (A) and cyclophosphamide (C) followed-by docetaxel (T) arm of NSABP B-30: preliminary results. [Abstract] J Clin Oncol 23 (Suppl 16): A-537, 13s, 2005.

  • Bandos H, Melnikow J, Rivera DR, Swain SM, Sturtz K, Fehrenbacher L, Wade JL 3rd, Brufsky AM, Julian TB, Margolese RG, McCarron EC, Ganz PA. Long-term Peripheral Neuropathy in Breast Cancer Patients Treated With Adjuvant Chemotherapy: NRG Oncology/NSABP B-30. J Natl Cancer Inst. 2018 Feb 1;110(2):djx162. doi: 10.1093/jnci/djx162.

    PubMed 28954297

  • Swain SM, Jeong JH, Geyer CE Jr, Costantino JP, Pajon ER, Fehrenbacher L, Atkins JN, Polikoff J, Vogel VG, Erban JK, Rastogi P, Livingston RB, Perez EA, Mamounas EP, Land SR, Ganz PA, Wolmark N. Longer therapy, iatrogenic amenorrhea, and survival in early breast cancer. N Engl J Med. 2010 Jun 3;362(22):2053-65. doi: 10.1056/NEJMoa0909638.

    PubMed 20519679

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cyclophosphamide, docetaxel and doxorubicin in people with Breast Cancer, run by NSABP Foundation Inc at 157 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 157 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: 8 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003782, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.

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