Semiglazov 2003.

Methods	Study design: described as randomised; no further information reported
Participants	212 patients with T1‐2N0M0 breast cancer (superficial tumours no larger than 2.5 cm in diameter)
Interventions	Modified mastectomy by Patey‐Dyson (1985‐90, 207 participants) vs organ‐sparing treatment (segmental resection of a breast + axillary dissection + radiotherapy – 1985‐97, 211 participants): sectorial or segmental resection performed 1 cm away from the tumour margin with axillary resection at the I‐II level. Radiotherapy done on gamma‐therapeutic apparatus “Rocus” with the use of classic fractionation (2 Gy daily 5 times a week) at a summative local dosage (SLD) applied to the breast of 50‐60 Gy. To the bed of the tumour, 10 Gy was applied additionally in 5 fractions. Zones of lymphatic collectors (axillary‐subclavian and parasternal) in cases when metastases were found were radiotreated with the analogous regimen (SLD = 40 Gr). All participants with receptor‐positive tumours received hormonal therapy with tamoxifen 20 mg daily for 5 years. Those with receptor‐negative tumours received adjuvant chemotherapy CMF (cyclophosphamide + methotrexate + 5‐fluorouracil) or FAC (5‐flurouracil + doxorubicin + cyclophosphamide) up to 6 courses.
Outcomes	Survival, local recurrence, distant metastasis
Notes	Paper was published in Russian and, after initial translation of sections related to treatment group allocation and axillary treatment by Dr Liliya‐Eugenevna Ziganshina (Department of Basic and Clinical Pharmacology, Kazan Federal University, Russian Federation), which showed that these sections did not provide sufficient detail, we emailed study author on 16/6/15 to ask for additional study details, specifically answers to the following two questions: 1. How were participants allocated to receive EITHER modified mastectomy OR organ‐sparing treatment (segmental resection of a breast + axillary dissection + radiotherapy)? Were they randomised to either of these treatment groups, and, if yes, how were they randomised? We would appreciate it if you would give us as much detail as possible about the recruitment and treatment allocation process. 2. Exactly what interventions did the 2 treatment groups receive to the axilla? Again, we are interested in learning as much detail as possible, including the level of node clearance (level I, I, or III). On 9/7/15, we received the following response: "Thank you for your attention to our studies performed in 1985 and 1990, “Sparing and organ‐saving operations in breast cancer,” and “The modern organ‐ and function‐sparing surgical treatment in oncology. "The first trial included patients with clinically early breast cancer (c)T1‐2N0M0. The second one included only patients with (c)T1N0M0. Patients were randomly assigned in a 1:1 ratio to receive Patey‐Dyson modified mastectomy versus segmental resection of the breast + axillary lymph node dissection up to level I or level II (in case of detection of axillary metastases in level I nodes as a result of intraoperative biopsy – in 20% of conservative surgery arm and 23% in modified mastectomy group). Randomization was done centrally at the department of Epidemiology and Statistics at the N.N. Petrov Research Institute of Oncology operation office with a computer program and a minimization technique, taking into account age, histologic type and grade (G) and hormone‐receptor status. The same principles were used in the second trial in which patients with (c)T1N0M0 were undergoing breast conservative surgery ± radiotherapy. Sentinel lymph node biopsy with the use of radio‐tracer has been routinely performed in (c)N0 patients in our institute for ten years by now. In 2014 we initiated a study to evaluate the role of the sentinel node biopsy in patients who had undergone neoadjuvant systemic therapy." Study author emailed again on 13/7/15, as no clear response had been received to the second question in our original email, i.e. exactly which interventions did patients receive to the axilla (e.g. what is a Patey‐Dyson modified mastectomy). Our second email was re‐sent on 17/8/15, as no response had been received. To date, we have received no response.