AzTrials
AzTrials

Breast CancerPhase 2NCT00003352

Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer

A Phase 2 study testing cyclophosphamide, Taxotere and Adriamycin in people with Breast Cancer, run by NSABP Foundation Inc at 166 sites in 3 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of doxorubicin, cyclophosphamide, and docetaxel in… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
cyclophosphamide, Taxotere and Adriamycin
Type of treatment
Injection or infusion
How many people
89 participants
Where
166 sitesin 3 countries
Study dates
Jun 1998to Dec 2002
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS: Histologically proven metastatic (stage IV) or locally advanced (stage IIIB) adenocarcinoma of the breast. Bidimensionally measurable disease. No active central nervous system (CNS) metastases. Brain metastases must be controlled for at least 3 months and have other sites of measurable disease. No carcinomatous meningitis. No lymphangitic lung metastases as the only site of metastatic disease. Hormone receptor status: Any estrogen or progesterone receptor status.

PATIENT CHARACTERISTICS: Age: 18 and over. Sex: Female. Menopausal status: Not specified. Performance status: Eastern Cooperative Oncology Group (ECOG) score range 0-2. Life expectancy: At least 6 months. Hematopoietic: Absolute neutrophil count at least 2,000/mm3. Platelet count at least 100,000/mm3. Hepatic: serum glutamic oxaloacetic transaminase (SGOT) and/or serum glutamic pyruvic transaminase (SGPT) no greater than 2.5 times upper limit of normal (ULN). Alkaline phosphatase no greater than 5 times ULN. Bilirubin no greater than ULN. No SGOT and/or SGPT greater than 1.5 times ULN if concomitant with alkaline phosphatase greater than 2.5 times ULN. Renal: Calcium no greater than 1.2 times ULN. Creatinine no greater than 1.5 times ULN. Cardiovascular:left ventricular ejection fraction (LVEF) at least institutional lower limit of normal on multiple gated acquisition scan (MUGA) or echocardiogram. No myocardial infarction within 6 months. No angina pectoris requiring antianginal medication. No history of congestive heart failure. No cardiac arrhythmias requiring medication. No vascular disease with documented cardiac function compromise No uncontrolled hypertension (diastolic greater than 100 mm Hg). Other: Not pregnant or nursing. Fertile patients must use effective barrier contraception. No diabetics with fasting blood sugar greater than 200 mg/dL. No peripheral neuropathy greater than grade 1. No psychosis or addictive disorders. No known hypersensitivity to E. coli-derived drugs.

PRIOR CONCURRENT THERAPY: Chemotherapy: No prior chemotherapy for metastatic breast cancer or non-breast cancer. At least 12 months since nontaxane containing adjuvant chemotherapy for primary tumor (in patients with metastatic disease). Prior adjuvant chemotherapy with anthracycline containing regimens allowed (provided total doxorubicin dose did not exceed 240 mg/m2). Endocrine therapy: At least 4 weeks since adjuvant hormone or hormone therapy for metastatic disease (at least 2 weeks for rapidly progressive disease). No concurrent hormonal birth control. Radiotherapy: At least 4 weeks since prior radiotherapy. Prior breast radiotherapy following lumpectomy allowed. No radiotherapy to greater than 30% of bone marrow. No prior left chest wall radiotherapy with anthracycline containing adjuvant chemotherapy. Surgery: Not specified.

Trial locations and contacts

166 sites in 3 countries.

166 sites in 3 countries

United States152 sites

  • Akron City Hospital

    Akron, Ohio, 44309

  • Albany Regional Cancer Center

    Albany, New York, 12208

  • University of New Mexico Cancer Research & Treatment Center

    Albuquerque, New Mexico, 87131

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18105-1556

  • CCOP - Ann Arbor Regional

    Ann Arbor, Michigan, 48106

  • Winship Cancer Center

    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

  • National Naval Medical Center

    Bethesda, Maryland, 20889-5000

  • St. Luke's Network - Bethlehem

    Bethlehem, Pennsylvania, 18015

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Baptist Medical Center - Birmingham

    Birmingham, Alabama, 35213

  • New England Medical Center Hospital

    Boston, Massachusetts, 02111

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • State University of New York Health Science Center at Brooklyn

    Brooklyn, New York, 11203

  • Lahey Clinic - Burlington

    Burlington, Massachusetts, 01805

  • CCOP - Cedar Rapids Oncology Project

    Cedar Rapids, Iowa, 52403-1206

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

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

    Chicago, Illinois, 60612

  • Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Barrett Cancer Center, The University Hospital

    Cincinnati, Ohio, 45219

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • Jewish Hospital of Cincinnati, Inc.

    Cincinnati, Ohio, 45236

  • Meridia South Pointe Hospital

    Cleveland, Ohio, 44122

  • Mount Sinai Medical Center - Cleveland

    Cleveland, Ohio, 44122

  • Ellis Fischel Cancer Center - Columbia

    Columbia, Missouri, 65203

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210

  • Medical Group of Texas

    Dallas, Texas, 75243

  • Penn State Geisinger Medical Center

    Danville, Pennsylvania, 17822-2001

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • Veterans Affairs Medical Center - Atlanta (Decatur)

    Decatur, Georgia, 30033

  • CCOP - Colorado Cancer Research Program, Inc.

    Denver, Colorado, 80209-5031

  • University of Colorado Cancer Center

    Denver, Colorado, 80262

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 10309-1016

  • Beckman Research Institute, City of Hope

    Duarte, California, 91010

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Michigan State University

    East Lansing, Michigan, 48824

  • Veterans Affairs Medical Center - East Orange

    East Orange, New Jersey, 07018-1095

  • CCOP - Evanston

    Evanston, Illinois, 60201

  • Veterans Affairs Medical Center - Fargo

    Fargo, North Dakota, 58102

  • CCOP - Merit Care Hospital

    Fargo, North Dakota, 58122

  • Regional Cancer Therapy Center - Frederick

    Frederick, Maryland, 21701

  • CCOP - Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • East Carolina University School of Medicine

    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

  • Highland Park Hospital

    Highland Park, Illinois, 60035-2497

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • Kelsey Seybold Clinic

    Houston, Texas, 77025

  • Huntsville Hospital System

    Huntsville, Alabama, 35801

  • Methodist Cancer Center - Indianapolis

    Indianapolis, Indiana, 46206-1367

  • Community Hospitals of Indianapolis - Regional Cancer Center

    Indianapolis, Indiana, 46219

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Baptist Regional Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Keesler Medical Center - Keesler AFB

    Keesler Air Force Base, Mississippi, 39534-2576

  • CCOP - Dayton

    Kettering, Ohio, 45429

  • Scripps Clinic and Research Foundation - La Jolla

    La Jolla, California, 92037

  • University of California San Diego Cancer Center

    La Jolla, California, 92093-0658

  • Wilford Hall - 59th Medical Wing

    Lackland Air Force Base, Texas, 78236-5300

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Lucille Parker Markey Cancer Center, University of Kentucky

    Lexington, Kentucky, 40536-0093

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Saint Mary Medical Center - Long Beach

    Long Beach, California, 90813-0887

  • Norton Healthcare System

    Louisville, Kentucky, 40202-5070

  • Baptist Hospital East - Louisville

    Louisville, Kentucky, 40207

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • CCOP - Marshfield Medical Research and Education Foundation

    Marshfield, Wisconsin, 54449

  • Veterans Affairs Medical Center - Memphis

    Memphis, Tennessee, 38104

  • CCOP - Baptist Cancer Institute

    Memphis, Tennessee, 38117

  • Sylvester Cancer Center, University of Miami

    Miami, Florida, 33136

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • MBCCOP - University of South Alabama

    Mobile, Alabama, 36688

  • Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08903

  • Louisiana State University Medical Center - New Orleans

    New Orleans, Louisiana, 70112

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • Veterans Affairs Medical Center - New Orleans

    New Orleans, Louisiana, 70112

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • Mount Sinai Medical Center, NY

    New York, New York, 10029

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Virginia Oncology Associates

    Newport News, Virginia, 23606

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23507

  • West Suburban Hospital Medical Center

    Oak Park, Illinois, 60302

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609-3305

  • Naval Medical Center - Oakland

    Oakland, California, 94627-5000

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • Methodist Cancer Center - Omaha

    Omaha, Nebraska, 68114

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68131

  • MD Anderson Cancer Center Orlando

    Orlando, Florida, 32806

  • Camden-Clark Memorial Hospital

    Parkersburg, West Virginia, 26102

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania, 19141

  • CCOP - Greater Phoenix

    Phoenix, Arizona, 85006-2726

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212-4772

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15213

  • Veterans Affairs Medical Center - Pittsburgh

    Pittsburgh, Pennsylvania, 15240

  • Berkshire Medical Center

    Pittsfield, Massachusetts, 01201

  • Oregon Cancer Center at Oregon Health Sciences University

    Portland, Oregon, 97201-3098

  • CCOP - Columbia River Program

    Portland, Oregon, 97213

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • Veterans Affairs Medical Center - Richmond

    Richmond, Virginia, 23249

  • Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • MBCCOP - Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Oncology and Hematology Associates of Southwest Virginia, Inc.

    Roanoke, Virginia, 24014

  • Genesee Hospital - Rochester

    Rochester, New York, 14607

  • Rockford Clinic

    Rockford, Illinois, 61103

  • Sutter Cancer Center

    Sacramento, California, 95816

  • Veterans Affairs Satellite Clinic - Sacramento

    Sacramento, California, 95820

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Veterans Affairs Medical Center - Salem

    Salem, Virginia, 24153

  • MBCCOP - South Texas Pediatric

    San Antonio, Texas, 78284-7810

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78284

  • Naval Medical Center - San Diego

    San Diego, California, 92134-3202

  • Veterans Affairs Medical Center - San Francisco

    San Francisco, California, 94121

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California, 95403

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • CCOP - Virginia Mason Research Center

    Seattle, Washington, 98101

  • Puget Sound Oncology Consortium

    Seattle, Washington, 98109

  • CCOP - Sioux Community Cancer Consortium

    Sioux Falls, South Dakota, 57105-1080

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Providence Hospital - Southfield

    Southfield, Michigan, 48075-9975

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • CCOP - Central Illinois

    Springfield, Illinois, 62526

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • St. Louis University School of Medicine

    St Louis, Missouri, 63104

  • 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, 13210

  • CCOP - Northwest

    Tacoma, Washington, 98405-0986

  • CCOP - Toledo Community Hospital Oncology Program

    Toledo, Ohio, 43623-3456

  • CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center

    Tulsa, Oklahoma, 74136

  • University of Texas Health Center at Tyler

    Tyler, Texas, 75710

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Kaiser Permanente Medical Center - Vallejo

    Vallejo, California, 94589

  • Kent County Memorial Hospital - Rhode Island

    Warwick, Rhode Island, 02886

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

  • Veterans Affairs Medical Center - Wichita

    Wichita, Kansas, 67218

  • CCOP - Christiana Care Health Services

    Wilmington, Delaware, 19899

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina, 27104-4241

  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157-1082

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania, 19096

Other trials in United States

Canada12 sites

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2W-W1T8

  • Royal Victoria Hospital - Montreal

    Montreal, Quebec, H3A 1A1

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • Jewish General Hospital - Montreal

    Montreal, Quebec, H3T 1E2

  • Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec

    Québec, Quebec, G1R 2J6

  • Hopital Laval

    Ste-Foy, Quebec, G1V 4G5

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • St. Michael's Hospital - Toronto

    Toronto, Ontario, M5B 1W8

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

  • Manitoba Cancer Treatment and Research Foundation

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Puerto Rico2 sites

  • MBCCOP - San Juan

    San Juan, 00927-5800

  • Veterans Affairs Medical Center - San Juan

    San Juan, 00927-5800

Other trials in Puerto Rico

About this study

Official title: A Phase II Study in Patients With Metastatic or Locally Advanced Breast Cancer to Evaluate the Worth of the Combination of Adriamycin (Doxorubicin), Taxotere (Docetaxel), and Cyclophosphamide (ATC)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of doxorubicin, cyclophosphamide, and docetaxel in treating women with stage IIIB or stage IV breast cancer.

Read the detailed description

OBJECTIVES: I. Determine the overall response rate to doxorubicin, docetaxel, and cyclophosphamide (ATC) in women with metastatic or locally advanced breast cancer. II. Determine survival, time to first response, time to progression, and duration of response in these patients. III. Evaluate the feasibility of administering ATC for at least 4 courses. IV. Evaluate the toxicity profile of ATC and its effect on cardiac function.

OUTLINE: Patients receive intravenous doxorubicin over 15 minutes on day 0, followed by intravenous cyclophosphamide over 30 minutes. An hour after the end of the doxorubicin infusion, intravenous docetaxel is administered over 1 hour. Patients receive courses every 21 days until disease progression or unacceptable toxic effects are observed. When the maximum dose of doxorubicin is reached, treatment continues with docetaxel and cyclophosphamide. Patients with locally advanced breast cancer receive chemotherapy for at least 2 courses after documented response. Patients are followed every 6 weeks.

PROJECTED ACCRUAL: Approximately 89 patients will be accrued to this study within 14 months.

Conditions
Breast Cancer
Being tested
cyclophosphamide, Taxotere, Adriamycin
Keywords
stage IV breast cancer, recurrent breast cancer, stage IIIB 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

    600 mg/m2, IV, every 3 weeks

  • TaxotereDrug

    Also called docetaxel

    60 mg/m2, IV, every 3 weeks

  • AdriamycinDrug

    Also called doxorubicin hydrochloride

    60 mg/m2, IV, every 3 weeks

What is being measured

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

  1. Best over-all tumor response that occurs during 6 cycles of chemotherapy

    Measured: 18 weeks

Secondary outcomes (6)

  1. Survival

    Measured: 18 weeks

  2. Time to first response

    Measured: 18 weeks

  3. Time to progression

    Measured: 18 weeks

  4. Duration of response

    Measured: 18 weeks

  5. Completion of at least four cycles of chemotherapy

    Measured: 12 weeks

  6. Toxicity profile

    Measured: 18 weeks

Timeline

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

  1. First posted27 Jun 2003 (estimated)
  2. Study startJun 1998
  3. Primary completionSep 2000
  4. Study completionDec 2002

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003352
Sponsor's protocol ID
NSABP BP-58
Other IDs
NSABP-BP-58
Status last verified
Dec 2012
First submitted
1 Nov 1999
Last updated
11 Dec 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Smith RE, Anderson SJ, Brown A, Scholnik AP, Desai AM, Kardinal CG, Lembersky BC, Mamounas EP. Phase II trial of doxorubicin/docetaxel/cyclophosphamide for locally advanced and metastatic breast cancer: results from NSABP trial BP-58. Clin Breast Cancer. 2002 Dec;3(5):333-40. doi: 10.3816/CBC.2002.n.036.

    PubMed 12533263

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cyclophosphamide, Taxotere and Adriamycin in people with Breast Cancer, run by NSABP Foundation Inc at 166 sites in 3 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 11 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 166 sites in United States, Canada, Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Best over-all tumor response that occurs during 6 cycles of chemotherapy (time frame: 18 weeks). 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 NCT00003352, which also lists 1 linked publication.

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 11 Dec 2012.

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