Phase
Condition
N/ATreatment
Post Mastectomy Radiation therapy
Clinical Study ID
Ages 18-80 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Women with unilateral pT1,2N0M0 breast cancer or multifocal breast cancer if largestdiscrete tumour at least 2cm or if the tumour area comprises multiple small adjacentfoci of invasive carcinoma then overall maximum dimension taken. This must begreater than 2cm.
Upfront total mastectomy (with minimum 1 mm margin clear of invasive cancer or DCIS)and axillary staging procedure (clearance, sampling or SNB)
T2 tumors with one risk factor or T1 tumors with any of the following two high riskfactors such as presence of high grade, lymphovascular invasion, ER/PR negative,HER2 positivity, age < 35 years.
Fit to receive adjuvant radiation +/- chemotherapy (if indicated) +/- hormonaltherapy (if indicated)
Written, informed consent
Exclusion
Exclusion Criteria:
Any pTis/3/4, M1 patients
Patients who have any pathologically involved axillary nodes (micro-metastasis maybe allowed)
Patients who have undergone neoadjuvant systemic therapy.
Previous or concurrent malignancy other than non melanomatous skin cancer andcarcinoma in situ of the cervix
Pregnancy
Bilateral breast cancer
Not fit for surgery, radiotherapy or adjuvant systemic therapy
Unable or unwilling to give informed consent
Study Design
Connect with a study center
All India Institute of Medical Sciences
New Delhi, Delhi 110029
IndiaSite Not Available
Max Super Speciality Hospital(A unit of Devki Devi Foundation)
New Delhi, Delhi 110017
IndiaSite Not Available
Kolhapur Cancer Centre Pvt Ltd
Kolhapur, Maharashtra 416234
IndiaSite Not Available
Tata Memorial Centre
Mumbai, Maharashtra 400012
IndiaActive - Recruiting
Bhagwan Mahaveer Cancer Hospital and Research Centre
Jaipur, Rajasthan 302017
IndiaSite Not Available
Post Graduate Institute of Medical Education & Research
Chandigarh, 160012
IndiaActive - Recruiting
Max Super Speciality Hospital, Shalimar Bagh
Delhi, 110088
IndiaSite Not Available
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