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Breast CancerPhase 3NCT00002967

Octreotide, Tamoxifen, and Chemotherapy in Treating Women With Breast Cancer

A Phase 3 study testing cyclophosphamide, doxorubicin hydrochloride and octreotide pamoate in people with Breast Cancer, run by NSABP Foundation Inc at 108 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. Combining hormone therapy with chemotherapy may kill more tumor cells. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Breast Cancer
What is being tested?
cyclophosphamide, doxorubicin hydrochloride and octreotide pamoate
How many people
Not given
Where
108 sitesin 2 countries
Study dates
May 1997to Mar 2006
Phase
Phase 3
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS: Histologically confirmed Stage I, IIA or IIB invasive adenocarcinoma of the breast with T1-3, pN0 and M0 classification Must have undergone total mastectomy or lumpectomy followed by an axillary dissection or sentinel node resection if participating in NSABP B-32 Histologically negative axillary lymph nodes OR Histologically negative sentinel lymph nodes if participating in NSABP B-32 Lumpectomy and axillary dissection acceptable only if margins of resected specimen are histologically free of invasive tumor or ductal carcinoma in situ and other dominant masses within the ipsilateral breast remnant are histologically confirmed to be benign Additional operation after resection is allowed in order to obtain clear margins No bilateral malignancy of the breast ER positive tumors as defined by at least one of the following: At least 10 fmol/mg cytosol protein by either dextran-coated charcoal or sucrose density gradient methods Positive or not definitely negative results by the enzyme immunoassay method (EIA) or by immunocytochemical assay No more than 63 days from time of initial cytologic or histologic diagnosis of breast cancer till randomization No bone metastases (confirmation must be made for those with skeletal pain) Tumor must be no greater than 5 cm in its greatest dimension for patients who are treated by lumpectomy and axillary dissection Hormone receptor status: Estrogen receptor positive

PATIENT CHARACTERISTICS: Age: Not specified Sex: Female Menopausal status: Not specified Life expectancy: At least 10 years (excluding diagnosis of cancer) Performance status: Not specified Hematopoietic: WBC at least 4,000/mm3 Platelet count postoperative at least 100,000/mm3 Hepatic: Bilirubin normal SGOT/SGPT normal Renal: Creatinine normal Cardiovascular: No cardiac disease that would preclude the use of doxorubicin (for patients who are to receive adjuvant chemotherapy in this study), including: Myocardial infarction Angina pectoris that requires antianginal medication History of congestive heart failure Arrhythmia associated with concurrent heart failure or cardiac dysfunction Valvular disease with cardiac compromise Cardiomegaly or ventricular hypertrophy unless left ventricular function is within normal limits Poorly controlled hypertension Other: No prior invasive breast cancer or ductal carcimoma in situ No systemic disease that would preclude patients from any part of study No history of symptomatic gallbladder or biliary tract disease unless patient has undergone cholecystectomy No ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude No prior nonbreast malignancies in past 10 years except: Squamous or basal cell carcinoma of the skin that has been effectively treated Carcinoma in situ of the cervix that has been treated by operation only Lobular carcinoma in situ of the ipsilateral or contralateral breast treated by segmented resection only No psychiatric or addictive disorders Not pregnant or nursing Negative pregnancy test

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for breast cancer Chemotherapy: No prior chemotherapy for breast cancer No prior anthracycline therapy for patients who are to receive adjuvant chemotherapy in this study Endocrine therapy: No prior endocrine therapy for breast cancer Must discontinue any sex hormonal therapy before prior to and during study Radiotherapy: No prior radiotherapy for breast cancer No breast radiation therapy before randomization for patients who receive lumpectomy Surgery: See Disease Characteristics At least 2 weeks since last surgical procedure Other: No concurrent cyclosporine therapy No concurrent heparin or warfarin anticoagulation therapy

Trial locations and contacts

108 sites in 2 countries.

108 sites in 2 countries

United States106 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

  • Winship Cancer Center

    Atlanta, Georgia, 30322

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342-1701

  • Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • 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

  • 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

  • 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

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210

  • CCOP - Colorado Cancer Research Program, Inc.

    Denver, Colorado, 80209-5031

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 10309-1016

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Michigan State University

    East Lansing, Michigan, 48824

  • CCOP - Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • East Carolina University School of Medicine

    Greenville, North Carolina, 27858-4354

  • 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

  • Huntsville Hospital System

    Huntsville, Alabama, 35801

  • Methodist Cancer Center - Indianapolis

    Indianapolis, Indiana, 46206-1367

  • Community Hospitals of Indianapolis - Regional Cancer Center

    Indianapolis, Indiana, 46219

  • Baptist Regional Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • 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

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Lucille Parker Markey Cancer Center, University of Kentucky

    Lexington, Kentucky, 40536-0093

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Norton Healthcare System

    Louisville, Kentucky, 40202-5070

  • CCOP - Marshfield Medical Research and Education Foundation

    Marshfield, Wisconsin, 54449

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • 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

  • 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

  • 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

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15213

  • 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

  • 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

  • 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

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • CCOP - Central Illinois

    Springfield, Illinois, 62526

  • 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

  • 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

  • York Hospital

    York, Pennsylvania, 17315

Other trials in United States

Canada2 sites

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • Jewish General Hospital - Montreal

    Montreal, Quebec, H3T 1E2

Other trials in Canada

About this study

Official title: A Clinical Trial to Evaluate the Benefit of Adding Octreotide (SMS 201-995 PA LAR) to Tamoxifen Alone or to Tamoxifen and Chemotherapy in Patients With Axillary Node-Negative, Estrogen-Receptor-Positive, Primary Invasive Breast Cancer

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

PURPOSE: Randomized phase III trial to study the effectiveness of tamoxifen, octreotide, and chemotherapy in treating women who have stage I or stage II breast cancer.

Read the detailed description

OBJECTIVES: I. Determine whether the addition of octreotide pamoate to tamoxifen alone or to tamoxifen and chemotherapy improves the disease free survival of patients with primary invasive breast cancer with estrogen receptor (ER) positive tumors and histologically negative axillary lymph nodes or histologically negative sentinel lymph nodes if participating in NSABP B-32. II. Determine whether the rate of endometrial cancer associated with tamoxifen is altered by the concurrent administration of octreotide pamoate. III. Determine whether the addition of octreotide pamoate to tamoxifen decreases the rate of opposite breast cancer more than tamoxifen alone. IV. Evaluate the incidence of gallstone formation (including the development of symptoms and complications of biliary tract disease), hyper and hypoglycemia, hypothyroidism, and vitamin B12 deficiency in patients treated with octreotide pamoate in comparison with patients not treated with octreotide pamoate.

OUTLINE: This is a randomized study. Patients are randomized into one of four treatment arms. Arm I: Patients receive oral tamoxifen (TMX) daily continously for 5 years. Lumpectomy patients receive breast radiotherapy following recovery from surgery. Arm II: Patients receive TMX as in Arm I and octreotide pamoate (SMS 201-995 pa LAR) intramuscularly (IM) every 21 days for 4 doses, followed by octreotide pamoate IM for 28 days for 23 additional doses. Lumpectomy patients receive breast radiotherapy following recovery from surgery. Arm III: Patients receive doxorubicin (DOX) IV and cyclophosphamide (CTX) IV every 3 weeks for 4 courses and TMX as in Arm I. Lumpectomy patients receive breast radiotherapy after recovery from chemotherapy. Arm IV: Patients receive DOX and CTX as in Arm III, TMX as in Arm I, and octreotide pamoate as in Arm II. Patients receive TMX and octreotide pamoate on day 1 of first course of chemotherapy. Lumpectomy patients receive breast radiotherapy after recovery from chemotherapy.

PROJECTED ACCRUAL: Total accrual of 3,000 patients will be acrrued for this study over 5 years.

Conditions
Breast Cancer
Being tested
cyclophosphamide, doxorubicin hydrochloride, octreotide pamoate, tamoxifen citrate
Keywords
stage I breast cancer, stage II breast cancer, invasive ductal breast carcinoma
Medical subject headings
Breast Neoplasms, Carcinoma, Ductal, Breast

What participants receive

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

Timeline

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

  1. First posted3 Sep 2004 (estimated)
  2. Study startMay 1997
  3. Study completionMar 2006

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002967
Sponsor's protocol ID
CDR0000065472
Other IDs
NSABP-B-29
Status last verified
Jun 2012
First submitted
1 Nov 1999
Last updated
21 Jun 2013
Results posted
No

Publications

  • Chapman JA, Costantino JP, Dong B, et al.: Randomized trials of adjuvant tamoxifen versus tamoxifen and octreotide LAR in early-stage breast cancer: NCIC CTG MA.14 and NSABP B-29. [Abstract] J Clin Oncol 30 (Suppl 15): A-538, 2012.

  • 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.

    PubMed 17060221

  • Chapman JA, Costantino JP, Dong B, Margolese RG, Pritchard KI, Shepherd LE, Gelmon KA, Wolmark N, Pollak MN. Octreotide LAR and tamoxifen versus tamoxifen in phase III randomize early breast cancer trials: NCIC CTG MA.14 and NSABP B-29. Breast Cancer Res Treat. 2015 Sep;153(2):353-60. doi: 10.1007/s10549-015-3547-4. Epub 2015 Aug 15.

    PubMed 26276354

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cyclophosphamide, doxorubicin hydrochloride and octreotide pamoate in people with Breast Cancer, run by NSABP Foundation Inc at 108 sites in 2 countries.

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

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 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?

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002967, which also lists 3 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 Jun 2013; AzTrials last refreshed its copy on 8 Nov 2026.

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