Know Cancer

or
forgot password

A RANDOMIZED TRIAL OF ANTIESTROGEN THERAPY VERSUS COMBINED ANTIESTROGEN AND OCTREOTIDE LAR THERAPY IN THE ADJUVANT TREATMENT OF BREAST CANCER IN POST-MENOPAUSAL WOMEN


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

Thank you

Trial Information

A RANDOMIZED TRIAL OF ANTIESTROGEN THERAPY VERSUS COMBINED ANTIESTROGEN AND OCTREOTIDE LAR THERAPY IN THE ADJUVANT TREATMENT OF BREAST CANCER IN POST-MENOPAUSAL WOMEN


OBJECTIVES: I. Compare event-free, recurrence-free, and overall survival following adjuvant
therapy with tamoxifen alone vs. tamoxifen plus octreotide long-acting release formulation
in postmenopausal women with stage I/II/III breast cancer. II. Compare the toxicity and
quality of life associated with each treatment regimen. III. Compare the effects of each
treatment regimen on insulin-like growth factor-I (IGF-I) physiology, and study the
relationship between IGF-I physiology and outcome.

OUTLINE: This is a randomized study. Patients are stratified by participating institution,
when and whether they receive adjuvant chemotherapy, axillary lymph node status, and hormone
receptor status. All patients are randomized within 12 weeks of definitive surgery. Patients
receiving adjuvant chemotherapy prior to protocol treatment are randomized within 6 weeks
after the last dose of chemotherapy. One group of patients receives daily oral tamoxifen,
while a second group receives daily oral tamoxifen plus octreotide (long-acting release
formulation) by monthly depot injection. Treatment in both groups continues for 5 years or
until disease recurrence or development of a second malignancy. Patients are followed
monthly for 4 months, every 4 months for 3 years, and every 6 months thereafter.

PROJECTED ACCRUAL: A total of 850 patients will be entered over 4.2 years in this
multicenter study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the breast that is
potentially curable Prior treatment with one of the following therapies required:
Segmental mastectomy (lumpectomy) followed by radiotherapy Chest wall irradiation allowed
only in patients with T4 dermal involvement on pathologic diagnosis Further excision or
boost radiotherapy to the tumor bed recommended if microscopic disease found at mastectomy
margins Total mastectomy Chest wall irradiation required if microscopic disease found at
mastectomy margins Clinical stage T1-3a N0-2 M0 disease prior to surgery The following T4
features exclude: Chest wall extension Edema (including peau d'orange) Skin ulceration
Satellite skin nodules confined to same breast Inflammatory carcinoma Pathologic stage
T1-4 NX-2 M0 disease following surgery Eligible T4 tumors are those with dermal
involvement on pathology assessment only Pathologic assessment of axillary lymph nodes
required May be omitted in patients with clinical N0 status provided other entry criteria
are met No bilateral breast cancer without complete resection of both sides Hormone
receptor status: Estrogen and progesterone receptor status determined from primary tumor
when possible by quantitative biochemical methods or immunohistochemistry Results recorded
as positive or negative if immunohistochemistry used Unknown status does not exclude
provided other entry criteria are met

PATIENT CHARACTERISTICS: Age: Postmenopausal Sex: Women only Menopausal status:
Postmenopausal by one or more of the following: Amenorrhea lasting more than 1 year in
women under 50 years of age with no prior hysterectomy No menses for 6 months prior to
breast surgery in women 50 years of age and over with no prior hysterectomy Documented
oophorectomy prior to breast cancer diagnosis Luteinizing hormone and follicle-stimulating
hormone values diagnostic of postmenopausal status by local laboratory criteria Women 50
years of age and over with prior hysterectomy Performance status: ECOG 0-2 Life
expectancy: At least 5 years Hematopoietic: WBC at least 3,000/mm3 Platelet count at least
100,000/mm3 Hepatic: (unless metastatic disease ruled out by radiologic exam) AST or ALT
less than twice normal Alkaline phosphatase less than twice normal Renal: Not specified
Other: No symptomatic gallbladder disease or cholecystitis No intercurrent illness that
reduces life expectancy to less than 5 years No other major medical or psychiatric illness
that precludes study treatment or follow-up No second malignancy within 5 years except:
Adequately treated basal cell skin carcinoma Adequately treated cancer of the cervix,
endometrium, colon, or thyroid Able and willing to complete quality-of-life questionnaires
in English or French Illiteracy, loss of sight, or other inability to complete
questionnaires does not exclude Accessible for treatment and follow-up

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: Prior
or concurrent adjuvant chemotherapy allowed at investigator's discretion Recommended
regimens: CMF (cyclophosphamide/methotrexate/fluorouracil) CEF
(cyclophosphamide/etoposide/fluorouracil) AC (doxorubicin/cyclophosphamide) Choice of
adjuvant chemotherapy regimen defined prior to randomization if given concurrently with
protocol therapy Endocrine therapy: No estrogen, progestins, or androgen therapy for a
period of more than 30 days following pathologic diagnosis of breast cancer Prior
tamoxifen allowed All hormonal therapy discontinued prior to randomization Radiotherapy:
See Disease Characteristics Surgery: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event-free survival

Outcome Time Frame:

6 years

Safety Issue:

No

Principal Investigator

Michael N. Pollak, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jewish General Hospital

Authority:

United States: Federal Government

Study ID:

MA14

NCT ID:

NCT00002864

Start Date:

August 1996

Completion Date:

April 2010

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage III breast cancer
  • Breast Neoplasms

Name

Location

St. Mary's/Duluth Clinic Health SystemDuluth, Minnesota  55805
Duluth ClinicDuluth, Minnesota  55805