None listed
Conditions
Brief summary
As a consequence of mammographic breast screening programs, ductal carcinoma in situ was diagnosed with increasing frequency. Mastectomy for localised DCIS was thought to be a overtreatment by many physicians, but there was much controversy as to whether complete local excision alone was sufficient. The trial aimed to assess the effectiveness of adjuvant radiotherapy and tamoxifen.
Interventions
Arm B: Complete local excision/lumpectomy followed by oral tamoxifen 20 mg daily for 5 years
Arm C: Complete local excision/lumpectomy followed by supervoltage radiotherapy to the residual breast tissue to a dose of 50Gy in 25 fractions over 5 weeks (or its equivalent)
Arm D: Complete local excision/lumpectomy followed by both radiotherapy to a dose of 50Gy in 25 fractions over 5 weeks (or its equivalent) and oral tamoxifen 20 mg daily for 5 years
PLEASE NOTE: Radiotherapists may choose altern
Arm B: Complete local excision/lumpectomy followed by oral tamoxifen 20 mg daily for 5 years Arm C: Complete local excision/lumpectomy followed by supervoltage radiotherapy to the residual breast tissue to a dose of 50Gy in 25 fractions over 5 weeks (or its equivalent) Arm D: Complete local excision/lumpectomy followed by both radiotherapy to a dose of 50Gy in 25 fractions over 5 weeks (or its equivalent) and oral tamoxifen 20 mg daily for 5 years PLEASE NOTE: Radiotherapists may choose alternate fractionation regimes, however treatment should not be given in less than 21 days or 15 fractions, and all alternative regimes should have a Tumour Dose Fractionation value of between 77 and 82. Whatever regime used, it is advised that the maximal tissue dose should not exceed the prescribed tumour dose by more than +10 percent.
Sponsors
Breast Cancer Trials
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with unilateral or bilateral DCIS cosmetically suited to breast conservation, which has been detected as a result of attendance at a screening centre, which is without evidence of invasion, and which has been completely excised as determined by free margins on histological examination. Patients, with similarly defined DCIS lesions, in whom the diagnosis of DCIS has been made as a result of mammograms taken following referral to a diagnostic clinic. Informed consent. Note: The wish to continue hormone replacement therapy for menopausal symptoms or the contraceptive pill will not exclude the patient from trial entry. Continued or subsequent use will be recorded on the follow-up form.
Exclusion criteria
Paget's disease of the nipple. Lobular carcinoma in-situ or atypical hyperplasia of the breast in the absence of DCIS. Note: Patients with in-situ carcinoma which is of mixed lobular and ductal type are eligible. Cases in which the pathologist is unable to state that the excision margins are clear, even after re-excision. Histologically confirmed involvement of any axillary lymph nodes, indentified either as an incidental finding on examination of a CLE specimen or as a result of excision of a palpable node, constitutes invasion irrespective of breast histology. Patients for whom any of the treatment options are considered inappropriate. Patients with a reduced life expectancy due to either prior or concomitant invasive malignant disease or a non-malignant condition.
Outcome results
None listed