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Adjuvant Therapy for Post/Perimenopausal Patients With Node Positive Breast Cancer Who Are Suitable for Endocrine Therapy Alone.

Phase 3
70 Years
Not Enrolling
Breast Cancer

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Trial Information

Adjuvant Therapy for Post/Perimenopausal Patients With Node Positive Breast Cancer Who Are Suitable for Endocrine Therapy Alone.

OBJECTIVES: I. Compare overall survival and local and systemic disease-free survival
produced by adjuvant chemoendocrine therapy with 4 courses of anthracycline/cyclophosphamide
and concurrent vs. sequential tamoxifen (TMX) or toremifene (TOR) in peri- and
postmenopausal women with node-positive breast cancer who are considered suitable for
endocrine therapy alone. II. Evaluate these same endpoints in patients randomized to
chemoendocrine therapy vs. endocrine therapy alone. III. Evaluate these same endpoints in
patients randomized to TMX vs. TOR as the endocrine therapy agent. IV. Compare the quality
of life of patients treated on these regimens. V. Compare the toxic effects of these

OUTLINE: This is a randomized study. Patients are stratified by type of primary therapy and
participating institution. Therapy must begin within 6 weeks of surgery. Patients in the
first group receive doxorubicin (or epirubicin) and cyclophosphamide every 28 days for a
total of 4 cycles and oral tamoxifen daily for 5 years, beginning day 1 of chemotherapy.
Patients in the second group receive the same chemotherapy with oral tamoxifen initiated on
day 8 of the fourth chemotherapy cycle and continued for 5 years. Patients in the third
group receive oral tamoxifen daily for 5 years. Patients in the fourth group are treated the
same as the first group, only tamoxifen is replaced by toremifene. Patients in the fifth
group are treated the same as the second group, only tamoxifen is replaced by toremifene.
Patients in the sixth group receive oral toremifene daily for 5 years. The timing of
optional radiotherapy for patients with less than total mastectomy in each group is based on
institutional policy; radiotherapy is administered for 5-6 weeks to the remaining breast
tissue, chest wall, and lung. Patients are followed every 3 months for 1 year, every 6
months for 2 years, and yearly thereafter.

PROJECTED ACCRUAL: 1,140 patients will be accrued over approximately 9 years, with 1
additional year of follow-up.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven stage T1-3, pN1, M0 carcinoma of the breast
considered suitable for adjuvant treatment with endocrine therapy alone Estrogen receptor
at least 10 fmol/mg cytosol protein or positive on immunohistochemical assay Potentially
curative resection within 6 weeks of entry by one of the following: Total mastectomy with
negative margins Breast-conserving procedure (lumpectomy or quadrantectomy) for tumors
less than 5 cm Adequate re-resection or mastectomy within 4 weeks of initial surgery
required if margins are positive after initial surgery Axillary clearance (not sampling)
required at surgery, with at least 1 node positive upon histopathologic examination of at
least 8 nodes Suspicious manifestations of metastatic disease (e.g., hot spots on bone
scan, skeletal pain of unknown cause) must be proven benign No bilateral breast cancer Any
mass in contralateral breast must be proven benign by biopsy

PATIENT CHARACTERISTICS: Age: 70 and under Sex: Women only Menopausal status:
Peri/postmenopausal, i.e.: More than 6 months since last normal menstrual period (LNMP)
with no prior hysterectomy and no hormone replacement therapy (HRT) Prior hysterectomy and
no HRT and either age greater than 55 or age 55 or less with postmenopausal LH, FSH, and
E2 levels On HRT and either age 50 or greater or LNMP more than 6 months prior to starting
HRT Performance status: Not specified Hematopoietic: WBC greater than 4,000 Platelets
greater than 100,000 Hepatic: Bilirubin less than 1.1 mg/dL (20 micromoles/L) AST less
than 60 IU/L Renal: Creatinine less than 1.3 mg/dL (120 micromoles/L) Other: No
nonmalignant systemic disease that would preclude protocol therapy or prolonged follow-up
No psychiatric or addictive disorder that would preclude informed consent No prior or
concurrent second malignancy except: Nonmelanomatous skin cancer Adequately treated in
situ carcinoma of the cervix Geographically accessible for follow-up

PRIOR CONCURRENT THERAPY: No prior therapy for breast cancer other than potentially
curative surgery (see Disease Characteristics)

Type of Study:


Study Design:

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

Outcome Measure:

Overall survival

Outcome Description:

Time from randomization to death.

Outcome Time Frame:

17 years after randomization

Safety Issue:


Principal Investigator

Edda Simoncini, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Spedali Civili di Brescia


United States: Federal Government

Study ID:




Start Date:

May 1993

Completion Date:

August 2010

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms