Big 3-07 trial

Secondary Outcome Measures : Overall survival [ Time Frame: Measured from the date of randomization to the date of death from any cause. Main analysis of secondary outcomes after all patients have completed 5 years of follow-up. Eligibility Criteria. Histologically proven DCIS of the breast without an invasive component.

Bilateral mammograms performed within 6 months prior to randomization. Clinically node-negative. Assessed by surgeon and radiation oncologist to be suitable for breast conserving therapy including whole breast RT. Ability to tolerate protocol treatment. Protocol RT should preferably commence within 8 weeks but must commence no later than 12 weeks from the last surgical procedure. ECOG performance status 0, 1 or 2.

Availability for long-term follow-up. Written informed consent. Locally recurrent breast cancer. Bilateral DCIS of the breasts Synchronous invasive carcinoma of the contralateral breast Other concurrent or previous malignancies except: Non-melanomatous skin cancer; Carcinoma in situ of the cervix or endometrium; and Invasive carcinoma of the cervix, endometrium, colon, thyroid and melanoma treated at least five years prior to study admission without disease recurrence.

Serious non-malignant disease that precludes definitive surgical or radiation treatment e. Women who are pregnant or lactating.

Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials. Gallen St. More Information. Lancet Oncol. Epub Mar National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Carcinoma, Ductal, Breast. Phase 3. The study of patients with DCIS treated with breast conserving surgery will examine: - The duration of whole breast radiation 3 weeks versus 5 weeks - Whole breast radiation plus a radiation boost for patients with a high risk of recurrence.

Using the patient data and tumour blocks collected, researchers will work to identify biomarkers to predict which patients are at high risk of recurrence and may require more intensive treatment; and which patients are at low risk of recurrence and may require less treatment.

Findings from this research can help tailor treatment to individual patients diagnosed with DCIS in the future. Patients aged 18 and older, with a confirmed diagnosis of DCIS, without invasive breast cancer. In total, 1, patients were recruited. To learn more about this study visit the TROG website. BIG against breast cancer. This trial is registered with ClinicalTrials. None of the other six prespecified aspects of HRQOL differed significantly after adjustment for multiple testing. No significant differences were reported in the other PROs between conventional whole breast radiotherapy compared with hypofractionated whole breast radiotherapy.

Interpretation: Tumour bed boost was associated with persistent adverse effects on cosmetic status and arm and shoulder functional status, which might inform shared decision making while local recurrence analysis is pending.