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
Tamoxifen With or Without Radiation Therapy in Treating Node-Negative Breast Cancer in Elderly Women
Basic Trial Information
|Phase III||Treatment||Completed||70 and over||NCI||CLB-9343|
E-C9343, RTOG-9702, CALGB-9343
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.
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
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
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
It is expected that 572 patients will be accrued over 38 months.
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.
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.
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
Ph: 617-724-0048; 877-726-5130
Eastern Cooperative Oncology Group
Ph: 973-971-6100; 800-247-9580
Radiation Therapy Oncology Group
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.