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Clinical Trials/CTRI/2016/12/007532
CTRI/2016/12/007532
Recruiting
Phase 3

Post-Mastectomy Radiation Therapy in High Risk, Node Negative women with Early Breast Cancer (PMRT-NNBC) - PMRT-NNBC

Tata Memorial Centre0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: null- Women with early breast cancer who have undergone upfront mastectomy for breast cancer and have negative nodes

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: null- Women with early breast cancer who have undergone upfront mastectomy for breast cancer and have negative nodes
Sponsor
Tata Memorial Centre
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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