Trial Evaluating Role of Post Mastectomy Radiotherapy in Women With Node Negative Early Breast Cancer (PMRT-NNBC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breastcancer
• Intervention / Treatment: Radiation: Post Mastectomy Radiation therapy

• Study Type: Interventional
• Enrollment (Estimated): 1022
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tabassum Wadasadawala, MBBS,MD,DNB; Phone Number: 02227405078; Email: twadasadawala@actrec.gov.in

Study Locations

• India
  • Chandigarh, India, 160012
    • Recruiting
    • Post Graduate Institute of Medical Education & Research
    • Contact: Budhi S Yadav, MBBS,MD; Phone Number: 9815981176; Email: drbudhi@gmail.com
    • Contact: Budhi S Yadav, MBBS,MD
  • Delhi, India, 110088
    • Not yet recruiting
    • Max Super Speciality Hospital, Shalimar Bagh
    • Contact: Vineeta Goel, MBBS, DNB; Phone Number: 9818045469; Email: vineetagoel@yahoo.com
    • Contact: Vineeta Goel, MBBS,DNB
  • Delhi
    • New Delhi, Delhi, India, 110017
      • Not yet recruiting
      • Max Super Speciality Hospital(A unit of Devki Devi Foundation)
      • Contact: Anil K Anand, MBBS,MD; Phone Number: 9810398838; Email: akanand@maxhealthcare.com
      • Contact: Anil K Anand, MBBS,MD
    • New Delhi, Delhi, India, 110029
      • Not yet recruiting
      • All India Institute of Medical Sciences
      • Contact: Ritesh Kumar, MBBS, MD; Phone Number: 9953774134; Email: riteshkr9@gmail.com
      • Contact: Ritesh Kumar, MBBS, MD
  • Maharashtra
    • Kolhapur, Maharashtra, India, 416234
      • Not yet recruiting
      • Kolhapur Cancer Centre Pvt Ltd
      • Contact: Yogesh Anap, MBBS,MD,DNB; Phone Number: 9420635556; Email: yogesh.anap1@gmail.com
      • Contact: Yogesh Anap, MBBS,MD,DNB
    • Mumbai, Maharashtra, India, 400012
      • Recruiting
      • Tata Memorial Centre
      • Contact: Tabassum Wadasadawala, MBBS,MD,DNB; Phone Number: 02227405078; Email: twadasadawala@actrec.gov.in
      • Contact: Tabassum Wadasadawala, MBBS,MD,DNB
  • Rajasthan
    • Jaipur, Rajasthan, India, 302017
      • Not yet recruiting
      • Bhagwan Mahaveer Cancer Hospital and Research Centre
      • Contact: Nidhi Patni, MBBS,MD; Phone Number: 9828052239; Email: nidhionco@gmail.com
      • Contact: Nidhi Patni, MBBS, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• 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 risk factors such as presence of high grade, lymphovascular invasion, ER/PR negative, HER2 positivity, age < 35 years.
• Fit to receive adjuvant radiation +/- chemotherapy (if indicated) +/- hormonal therapy (if indicated)
• Written, informed consent

Exclusion Criteria:

• Any pTis/3/4, M1 patients
• Patients who have any pathologically involved axillary nodes (micro-metastasis may be allowed)
• Patients who have undergone neoadjuvant systemic therapy.
• Previous or concurrent malignancy other than non melanomatous skin cancer and carcinoma 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Post Mastectomy Radiation Therapy (PMRT); Post mastectomy radiotherapy will be given	Radiation: Post Mastectomy Radiation therapy; Post mastectomy radiotherapy to the chest wall and ipsilateral supra-clavicular fossa to a dose of 40 Gy in 15 fractions over 3 weeks; Other Names: PMRT
No Intervention: Observation (No PMRT); No adjuvant radiotherapy will be given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease free survival	This will be measured using Kaplan Meier time to event analysis	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chest wall recurrence	This is the incidence of local recurrence in the chest wall	5 years
Regional recurrence	This is the incidence of recurrence in the regional lymphatics	5 years
Metastasis-free survival	This will be measured using Kaplan Meier time to event analysis	5 years
Overall survival	This will be measured using Kaplan Meier time to event analysis	5 years
Acute Morbidity of radiotherapy	RTOG Acute radiation morbidity scoring	4 weeks from the start of radiotherapy
Late Morbidity of radiotherapy	RTOG Late radiation morbidity scoring	6 months from end of radiotherapy to 5 years
Quality of life scores under different domains of the QLQ C-30 and BR-23 questionnaires	Quality of life will be assesses by EORTC QLQ C-30 core questionnaire and the breast cancer specific module BR-23 questionnaire	5 years post surgery

Collaborators and Investigators

• Sponsor: Tata Memorial Centre
• Investigators: Principal Investigator: Tabassum Wadasadawala, MBBS,MD,DNB, Assistant Professor, Radiation Oncology, Tata Memorial Centre

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2016
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2033

Study Registration Dates

• First Submitted: December 11, 2016
• First Submitted That Met QC Criteria: December 13, 2016
• First Posted (Estimated): December 14, 2016

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Post-Mastectomy Radiation; Node Negative; Early breast Cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 1602; CTRI/2016/12/007532 (Registry Identifier: Clinical Trial Registry- India)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO