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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


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

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Richard G. Margolese, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jewish General Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000065472

NCT ID:

NCT00002967

Start Date:

May 1997

Completion Date:

March 2006

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • invasive ductal breast carcinoma
  • Breast Neoplasms

Name

Location

Akron City HospitalAkron, Ohio  44304
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
East Carolina University School of MedicineGreenville, North Carolina  27858-4354
Rhode Island HospitalProvidence, Rhode Island  02903
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
CCOP - Colorado Cancer Research Program, Inc.Denver, Colorado  80209-5031
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
New England Medical Center HospitalBoston, Massachusetts  02111
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Northern New JerseyHackensack, New Jersey  07601
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
CCOP - DuluthDuluth, Minnesota  55805
MD Anderson Cancer Center OrlandoOrlando, Florida  32806
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
Medical College of WisconsinMilwaukee, Wisconsin  53226
Huntsville Hospital SystemHuntsville, Alabama  35801
MBCCOP - University of South AlabamaMobile, Alabama  36688
Loma Linda University Medical CenterLoma Linda, California  92354
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
CCOP - Central IllinoisSpringfield, Illinois  62526
Community Hospitals of Indianapolis - Regional Cancer CenterIndianapolis, Indiana  46219
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Methodist Cancer Center - OmahaOmaha, Nebraska  68114
Newark Beth Israel Medical CenterNewark, New Jersey  07112
Genesee Hospital - RochesterRochester, New York  14607
CCOP - ColumbusColumbus, Ohio  43206
CCOP - DaytonKettering, Ohio  45429
CCOP - Columbia River ProgramPortland, Oregon  97213
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
York HospitalYork, Pennsylvania  17315
Massey Cancer CenterRichmond, Virginia  23298-0037
CCOP - Marshfield Medical Research and Education FoundationMarshfield, Wisconsin  54449
Baptist Regional Cancer Institute - JacksonvilleJacksonville, Florida  32207
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Boston Medical CenterBoston, Massachusetts  02118
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
CCOP - NorthwestTacoma, Washington  98405-0986
CCOP - Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Oregon Cancer Center at Oregon Health Sciences UniversityPortland, Oregon  97201-3098
Puget Sound Oncology ConsortiumSeattle, Washington  98109
Sutter Cancer CenterSacramento, California  95816
Kaiser Permanente Medical Center - VallejoVallejo, California  94589
Hartford HospitalHartford, Connecticut  06102-5037
Sarasota Memorial HospitalSarasota, Florida  34239
Illinois Masonic Medical CenterChicago, Illinois  60657
West Suburban Hospital Medical CenterOak Park, Illinois  60302
Rockford ClinicRockford, Illinois  61103
Lucille Parker Markey Cancer Center, University of KentuckyLexington, Kentucky  40536-0093
Norton Healthcare SystemLouisville, Kentucky  40202-5070
Louisiana State University Medical Center - New OrleansNew Orleans, Louisiana  70112
Eastern Maine Medical CenterBangor, Maine  04401
Franklin Square Hospital CenterBaltimore, Maryland  21237
Lahey Clinic - BurlingtonBurlington, Massachusetts  01805
Berkshire Medical CenterPittsfield, Massachusetts  01201
Michigan State UniversityEast Lansing, Michigan  48824
St. Louis University School of MedicineSaint Louis, Missouri  63104
University of New Mexico Cancer Research & Treatment CenterAlbuquerque, New Mexico  87131
Albany Regional Cancer CenterAlbany, New York  12208
Staten Island University HospitalStaten Island, New York  10305
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Jewish Hospital of Cincinnati, Inc.Cincinnati, Ohio  45236
St. Luke's Network - BethlehemBethlehem, Pennsylvania  18015
University of Texas Health Center at TylerTyler, Texas  75708
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Eastern Virginia Medical SchoolNorfolk, Virginia  23507
Oncology and Hematology Associates of Southwest Virginia, Inc.Roanoke, Virginia  24014
Camden-Clark Memorial HospitalParkersburg, West Virginia  26102
Kent County Memorial Hospital - Rhode IslandWarwick, Rhode Island  02886
Virginia Oncology AssociatesNewport News, Virginia  23606
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer CenterTulsa, Oklahoma  74136
Baptist Medical Center - BirminghamBirmingham, Alabama  35213
Scripps Clinic and Research Foundation - La JollaLa Jolla, California  92037
Ocala Oncology CenterOcala, Florida  34474
Winship Cancer CenterAtlanta, Georgia  30322
Highland Park HospitalHighland Park, Illinois  60035-2497
Methodist Cancer Center - IndianapolisIndianapolis, Indiana  46206-1367
Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Good Samaritan Hospital - CincinnatiCincinnati, Ohio  45220
Mount Sinai Medical Center - ClevelandCleveland, Ohio  44122
Meridia South Pointe HospitalCleveland, Ohio  44122