Randomized trial evaluating role of post mastectomy radiotherapy in women with node negative early breast cancer

Phase 3

Conditions: Health Condition 1: null- Women with early breast cancer who have undergone upfront mastectomy for breast cancer and have negative nodes

Registration Number: CTRI/2016/12/007532

Lead Sponsor: Tata Memorial Centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

i.Women with unilateral pT1,2N0M0 breast cancer or multifocal breast cancer if largest discrete tumour at least 2cm or if the tumour area comprises multiple small adjacent foci of invasive carcinoma then overall maximum dimension taken. This must be greater than 2cm.

ii.Upfront total mastectomy (with minimum 1 mm margin clear of invasive cancer or DCIS) and axillary staging procedure (clearance, sampling or SNB)

iii.T2 tumors with one risk factor or T1 tumors with any of the following two high risk factors such as presence of high grade, lymphovascular invasion, ER/PR negative, HER2 positivity, age < 35 years.

iv.Fit to receive adjuvant radiation +/- chemotherapy (if indicated) +/- hormonal therapy (if indicated)

v.Written, informed consent

Exclusion Criteria

i.Any pTis/3/4, M1 patients

ii.Patients who have any pathologically involved axillary nodes (micromets may be allowed)

iii.Patients who have undergone neoadjuvant systemic therapy.

iv.Previous or concurrent malignancy other than non melanomatous skin cancer and carcinoma in situ of the cervix

v.Pregnancy

vi.Bilateral breast cancer

vii.Not fit for surgery, radiotherapy or adjuvant systemic therapy

viii.Unable or unwilling to give informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease free survivalTimepoint: 5 years

Secondary Outcome Measures

Name	Time	Method
i.Chest wall recurrence <br/ ><br>ii.Regional recurrence <br/ ><br>iii.Metastasis-free survival <br/ ><br>iv.Overall survival <br/ ><br>v.Acute and late morbidity <br/ ><br>vi.Quality of Life <br/ ><br>Timepoint: 5 years