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Trial Evaluating Role of Post Mastectomy Radiotherapy in Women With Node Negative Early Breast Cancer

Study acronym: PMRT-NNBC
StatusRecruiting
PhaseNot applicable
Started2016-05-27
View on ClinicalTrials.gov ↗

Amendment history

2025-04-07
minor
Study Status, Contacts/Locations v5
Study sitesdetails revised at 2 of 7 sites
2022-07-04
minor
Study Status, Study Design, Outcome Measures, Contacts/Locations v4
PhasePhase 3→Not applicable
Completion date2028-12→2033-12
Secondary endpoints7 entries, revised
Quality of life scores under different domains of the QLQ C-30 and BR-23 questionnaires
Study sitesdetails revised at 1 of 7 sites
2018-06-12
minor
Study Status, Contacts/Locations v3
Study sites5→7
2018-05-02
notable
Not Yet Recruiting→Recruiting Study Status, Sponsor/Collaborators, Study Design, Outcome Measures, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2016-12→2016-05-27
Secondary endpointsdetails revised at 2 of 7 entries
Study sites5 entries, revised
Max Super Speciality Hospital(A, unitShalimar of Balaji Medical & Diagnostic Research Centre)Bagh
2016-12-15
minor
Study Status, Outcome Measures v1
Secondary endpoints6 to 7 entries
Acute andMorbidity lateof morbidityradiotherapy Late Morbidity of radiotherapy
2016-12-13
minor
Original filing
Postmastectomy radiotherapy (PMRT) is unequivocally beneficial in reducing the recurrences as well as improving survival in node positive breast cancer patients. PMRT for women with T1-T2 tumors and negative axillary nodes is not generally warranted because of the presumed low risk of recurrence in this population as a whole. However, in the setting of multiple adverse prognostic factors, the recurrence risk approaches and in some cases surpasses the risk of recurrence documented for patients with one to three positive lymph nodes. Numerous retrospective series have reported the outcome and patterns of failure for post-mastectomy patients treated without radiation. Many of these series have analyzed several high risk factors which were predictive of loco-regional recurrence wherein the role of adjuvant post-mastectomy radiation can be considered. Some authors have used combinations of prognostic factors, such as age, tumour size, grade, receptor status, Her2neu status and lympho-vascular space invasion to define subgroups with more specific risks of loco-regional recurrence than single factors alone. The current trial hypothesizes that "Post-mastectomy radiation in high risk, node negative early breast cancer patients decreases rates of loco-regional recurrence and improves disease free survival" and propose to address the question in randomized setting.
Trial Details
NCT Number NCT02992574
Lead Sponsor Tata Memorial Centre
Conditions Breastcancer
Enrollment 1,022 participants
Start Date 2016-05-27
Primary Completion 2028-12 (estimated)
Study Completion 2033-12 (estimated)
Updated on ClinicalTrials.gov 2025-04-10