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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/12/007532

Enrollment

1022

Registered

2016-12-05

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Adjuvant Radiotherapy: Post mastectomy radiotherapy will be given to the chest wall and ipsilateral supra-clavicular fossa to a dose of 40 Gy in 15 fractions over 3 weeks Control Interv

Eligibility

Inclusion 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 iv. Fit to receive adjuvant radiation +/- chemotherapy (if indicated) +/- hormonal therapy (if indicated) v. Written, informed consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Disease free survivalTimepoint: 5 years	—

Secondary

Measure	Time frame
i. Chest wall recurrence ii. Regional recurrence iii. Metastasis-free survival iv. Overall survival v. Acute and late morbidity vi. Quality of Life Timepoint: 5 years	—

Countries

India

Contacts

Public ContactTabassum Wadasadawala

ACTREC, TMC

twadasadawala@actrec.gov.in27405078

Outcome results