Intensive diagnostic follow-up after treatment of primary breast cancer: A randomized trial.

To evaluate the effectiveness of early detection of intrathoracic and bone metastases in reducing mortality in breast cancer patients. Randomized clinical trial allocating breast cancer patients to two alternative follow-up protocols (intensive vs clinical) for at least 5 years. Twelve breast clinics (referral centers) in different areas in Italy. A total of 1243 consecutive patients (either premenopausal or postmenopausal) surgically treated for unilateral invasive breast carcinoma with no evidence of metastases. The two study groups were well balanced in terms of clinical and prognostic characteristics. Patients in both treatment groups had physical examination and mammography, while patients of the intensive follow-up group had, in addition, chest roentgenography and bone scan every 6 months. Vital status at 5 years was the main outcome; information was available for all except five patients (0.4%). Relapse-free survival was also analyzed. Overall, 393 recurrences (104 local and 289...