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Surgical Therapy With or Without Axillary Node Clearance for Breast Cancer in the Elderly Who Receive Adjuvant Therapy With Tamoxifen.


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

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Trial Information

Surgical Therapy With or Without Axillary Node Clearance for Breast Cancer in the Elderly Who Receive Adjuvant Therapy With Tamoxifen.


OBJECTIVES:

- Compare local and systemic disease-free survival, ipsilateral axillary relapse,
occurrence of postmastectomy syndrome, and overall survival of elderly women with
clinically operable stage I or IIA breast cancer who subsequently receive adjuvant
tamoxifen after treatment with breast surgery with or without axillary node dissection.

- Compare the toxicity of these regimens in these patients.

- Compare the quality of life in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
whether they received prior primary surgery (yes vs no) and participating center.

- Arm I: Patients undergo mastectomy, lumpectomy, or quadrantectomy with axillary
clearance. Patients then receive oral tamoxifen for 5 years. Patients may also undergo
sentinel node biopsy.

- Arm II: Patients undergo surgery as in arm I without axillary clearance. Patients then
receive oral tamoxifen for 5 years.

Patients in both arms who undergo breast-conserving surgery may receive optional
radiotherapy for 5-6 weeks to the remaining breast tissue, chest, and lung. Upon recurrence
in the conserved breast, patients undergo total mastectomy; those in arm II who experience
ipsilateral axillary recurrence undergo surgical excision. Adjuvant tamoxifen and follow up
are continued.

Quality of life is assessed.

Patients are followed every 3 months for 1 year, every 6 months while receiving tamoxifen,
and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,020 patients will be accrued for this study within
approximately 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed stage I or IIA breast carcinoma that is
considered operable

- No prior axillary clearance or biopsy

- Complete excisional biopsy of primary tumor without axillary clearance or biopsy
allowed

- Suspicious manifestations of metastatic disease (e.g., hot spots on bone scan or
skeletal pain of unknown cause) must be proven benign

- No bilateral breast cancer (any mass in contralateral breast must be proven benign by
biopsy)

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age:

- 60 and over

Sex:

- Female

Menopausal status

- Postmenopausal

Performance status:

- Not specified

Hematopoietic:

- WBC greater than 4,000/mm^3

- Platelet count greater than 100,000/mm^3

Hepatic:

- Bilirubin less than 1.1 mg/dL

- AST less than 60 U/L

Renal:

- Creatinine less than 1.3 mg/dL

Cardiovascular:

- Normal cardiac function

- No history of congestive heart failure

Other:

- No nonmalignant systemic disease that would preclude protocol therapy or prolonged
follow-up

- No psychiatric or addictive disorder that would preclude protocol therapy or informed
consent

- No other prior or concurrent malignancy except nonmelanomatous skin cancer or
adequately treated carcinoma in situ of the cervix

- Geographically accessible for follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior biologic therapy for breast cancer

Chemotherapy:

- No prior chemotherapy for breast cancer

Endocrine therapy:

- No prior endocrine therapy for breast cancer

Radiotherapy:

- No prior radiotherapy for breast cancer

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:

Disease-free survival

Outcome Description:

Time from randomization to recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first.

Outcome Time Frame:

17 years from randomization

Safety Issue:

No

Principal Investigator

Diana Crivellari, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Centro di Riferimento Oncologico - Aviano

Authority:

United States: Federal Government

Study ID:

CDR0000078383

NCT ID:

NCT00002528

Start Date:

May 1993

Completion Date:

August 2010

Related Keywords:

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

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