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Clinical Trials (PDQ®)

Phase III Randomized Study of Adjuvant Tamoxifen with vs without Radiotherapy Following Lumpectomy for Carcinoma of the Breast No Greater Than 2 cm with Clinically Negative Axillary Nodes in Women Age 70 and Over

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Alternate Title

Tamoxifen With or Without Radiation Therapy in Treating Node-Negative Breast Cancer in Elderly Women

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompleted70 and overNCICLB-9343
E-C9343, RTOG-9702, CALGB-9343

Objectives

I.  Assess whether radiotherapy decreases the rate of locoregional recurrence 
following lumpectomy when added to tamoxifen in patients 70 years of age or 
older who have carcinoma of the breast that is no greater than 2 cm and with 
no palpable axillary nodes.

II.  Assess whether radiotherapy decreases the incidence of subsequent 
mastectomy in this patient population.

III.  Estimate the overall survival, disease-free survival, and breast 
cancer-specific mortality following lumpectomy and tamoxifen with vs. without 
radiotherapy.

IV.  Assess the morbidity associated with each treatment arm.

Entry Criteria

Disease Characteristics:


Histologically documented invasive adenocarcinoma of the breast as follows:
  Primary tumor no greater than 2 cm by clinical, mammographic, or pathologic
  criteria
     Tumor movable in relation to the chest wall

  Clinically negative axillary and supraclavicular lymph nodes required
     If axillary dissection performed, pathologically negative or positive
     nodes allowed provided nodes were clinically negative prior to removal

  No skin ulceration, peau d'orange, or inflammatory changes
     Local microscopic dermal or dermal lymphatic involvement allowed

  No evidence of metastatic disease on pretherapy studies
     Ultrasound, CT, or MRI of liver required to exclude metastatic disease in
     patients with abnormal liver function tests

Breast-sparing surgery (partial mastectomy/lumpectomy) required prior to
randomization
  Excisional biopsy, including entire palpable mass or mammographic
  abnormality with a small rim of normal breast tissue, is considered
  lumpectomy

  Patients with pathologically positive margins following
  lumpectomy/excisional biopsy are eligible for randomization following
  re-excision and achievement of tumor-free margins

  Initiation of tamoxifen between surgery and entry does not exclude

Prior contralateral breast cancer allowed provided patient has been
disease-free for at least 5 years

Hormone receptor status:
  Estrogen receptor positive (ER+) or indeterminate
     ER+ = at least 10 fmoles/mg cytosol protein OR
           at least 20% of cells staining positive by immunohistochemistry


Prior/Concurrent Therapy:


Biologic therapy:
  Not specified

Chemotherapy:
  Not specified

Endocrine therapy:
  Estrogen replacement therapy must be discontinued prior to entry

Radiotherapy:
  No prior radiotherapy to ipsilateral breast, chest wall, or axilla

Surgery:
  See Disease Characteristics
  No prior simple mastectomy, modified radical mastectomy, or radical
     mastectomy of the affected side
  No more than 12 weeks between breast-sparing surgery and randomization


Patient Characteristics:


Age:
  70 and over

Sex:
  Women only

Menopausal status:
  Postmenopausal

Performance status:
  Any

Hematopoietic:
  Not specified

Hepatic:
  See Disease Characteristics

Renal:
  Not specified

Other:
  Ability to lie on back with arm raised superior to head sufficiently to
     undergo radiotherapy required
  No second malignancy within 5 years except:
     Inactive nonmelanomatous skin cancer
     In situ carcinoma of the cervix

Bloodwork must be completed within 3 months prior to entry
  Abnormal values allowed


Expected Enrollment

It is expected that 572 patients will be accrued over 38 months.

Outline

This is a randomized study.  Patients are stratified by participating 
institution, age, and axillary dissection.

One group of patients receives oral tamoxifen daily for 5 years.

The second group receives oral tamoxifen daily for 5 years plus radiotherapy 
to the tumor bed and ipsilateral breast.

No hormone or hormone analogue therapy is allowed except steroids for adrenal 
failure and hormones administered for nondisease-related conditions.

All patients are followed every 4 months for 5 years, then annually.

Published Results

Hughes KS, Schnaper LA, Berry D, et al.: Lumpectomy plus tamoxifen with or without irradiation in women 70 years of age or older with early breast cancer: a report of further follow-up. [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-11, S8, 2006.

Hughes KS, Schnaper LA, Berry D, et al.: Lumpectomy plus tamoxifen with or without irradiation in women 70 years of age or older with early breast cancer. N Engl J Med 351 (10): 971-7, 2004.[PUBMED Abstract]

Hughes KS, Schnaper L, Berry D, et al.: Comparison of lumpectomy plus tamoxifen with and without radiotherapy (RT) in women 70 years of age or older who have clinical stage I, estrogen receptor positive (ER+) breast carcinoma. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-93, 24a, 2001.

Related Publications

Soulos PR, Yu JB, Roberts KB, et al.: Assessing the impact of a cooperative group trial on breast cancer care in the medicare population. J Clin Oncol 30 (14): 1601-7, 2012.[PUBMED Abstract]

Patrice JR, Patrice SJ, Hayman JA, et al.: Cost-effectiveness of routine radiation therapy when added to tamoxifen following conservative surgery in older women with early-stage breast cancer. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-162, S91-92, 2007.

Smith BD, Gross CP, Smith GL, et al.: Effectiveness of radiation therapy for older women with early breast cancer. J Natl Cancer Inst 98 (10): 681-90, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Kevin Hughes, MD, FACS, Protocol chair
Ph: 617-724-0048; 877-726-5130
Email: kshughes@partners.org

Eastern Cooperative Oncology Group

Thomas Smith, MD, Protocol chair (Contact information may not be current)
Ph: 973-971-6100; 800-247-9580

Radiation Therapy Oncology Group

Beryl McCormick, MD, Protocol chair
Ph: 212-639-6828; 800-525-2225

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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