Actively Recruiting
Trial Evaluating Role of Post Mastectomy Radiotherapy in Women With Node Negative Early Breast Cancer
Led by Tata Memorial Centre · Updated on 2025-04-10
1022
Participants Needed
7
Research Sites
913 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trial Evaluating Role of Post Mastectomy Radiotherapy in Women With Node Negative Early Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with unilateral pT1 or pT2N0M0 breast cancer or multifocal breast cancer with tumor size over 2 cm
- Underwent total mastectomy with at least 1 mm clear margin and axillary staging
- T2 tumors with one high-risk factor or T1 tumors with two high-risk factors such as high grade, lymphovascular invasion, ER/PR negative, HER2 positive, or age under 35 years
- Suitable for adjuvant radiation, chemotherapy if needed, and hormonal therapy if needed
- Provided written informed consent
You will not qualify if you...
- Patients with pTis, pT3, pT4, or metastatic (M1) cancer
- Patients with any pathologically involved axillary lymph nodes (except micro-metastasis)
- Patients who had neoadjuvant systemic therapy before surgery
- Previous or current cancers other than non-melanoma skin cancer or cervical carcinoma in situ
- Pregnant women
- Patients with cancer in both breasts
- Not fit for surgery, radiotherapy, or systemic therapy
- Unable or unwilling to give informed consent
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Trial Site Locations
Total: 7 locations
1
Post Graduate Institute of Medical Education & Research
Chandigarh, Chandigarh, India, 160012
Actively Recruiting
2
Kolhapur Cancer Centre Pvt Ltd
Kolhāpur, Maharashtra, India, 416234
Not Yet Recruiting
3
Tata Memorial Centre
Mumbai, Maharashtra, India, 400012
Actively Recruiting
4
Max Super Speciality Hospital, Shalimar Bagh
Delhi, National Capital Territory of Delhi, India, 110088
Not Yet Recruiting
5
Max Super Speciality Hospital(A unit of Devki Devi Foundation)
New Delhi, National Capital Territory of Delhi, India, 110017
Not Yet Recruiting
6
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029
Not Yet Recruiting
7
Bhagwan Mahaveer Cancer Hospital and Research Centre
Jaipur, Rajasthan, India, 302017
Not Yet Recruiting
Research Team
T
Tabassum Wadasadawala, MBBS,MD,DNB
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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