RecruitingNot ApplicableNCT02992574

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)


Sponsor

Tata Memorial Centre

Enrollment

1,022 participants

Start Date

May 27, 2016

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether radiation therapy after mastectomy (breast removal surgery) is beneficial for women with early-stage breast cancer where the cancer has not spread to the lymph nodes, to find out if some women can safely skip post-surgical radiation. **You may be eligible if...** - You are a woman with early-stage breast cancer (stage T1 or T2, no lymph node involvement, no distant spread) - You have undergone a full mastectomy with clear margins (at least 1 mm of healthy tissue around the tumor) - You have also had a procedure to check your underarm lymph nodes - Your tumor was at least 2 cm in size (or involves multiple adjacent small tumors adding up to more than 2 cm) - Your tumor has certain risk features that make the question of radiation relevant **You may NOT be eligible if...** - Your cancer has spread to lymph nodes or distant organs - Your surgical margins were not clear - You had breast-conserving surgery (lumpectomy) rather than a full mastectomy - You have certain other medical conditions that make radiation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONPost 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


Locations(7)

Post Graduate Institute of Medical Education & Research

Chandigarh, Chandigarh, India

Kolhapur Cancer Centre Pvt Ltd

Kolhāpur, Maharashtra, India

Tata Memorial Centre

Mumbai, Maharashtra, India

Max Super Speciality Hospital, Shalimar Bagh

Delhi, National Capital Territory of Delhi, India

Max Super Speciality Hospital(A unit of Devki Devi Foundation)

New Delhi, National Capital Territory of Delhi, India

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

Bhagwan Mahaveer Cancer Hospital and Research Centre

Jaipur, Rajasthan, India

View Full Details on ClinicalTrials.gov

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NCT02992574