Trial Evaluating Role of Post Mastectomy Radiotherapy in Women With Node Negative Early Breast Cancer

Last updated: April 7, 2025
Sponsor: Tata Memorial Centre
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Post Mastectomy Radiation therapy

Clinical Study ID

NCT02992574
1602
CTRI/2016/12/007532
  • Ages 18-80
  • Female

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Women with unilateral pT1,2N0M0 breast cancer or multifocal breast cancer if largestdiscrete tumour at least 2cm or if the tumour area comprises multiple small adjacentfoci of invasive carcinoma then overall maximum dimension taken. This must begreater 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 riskfactors such as presence of high grade, lymphovascular invasion, ER/PR negative,HER2 positivity, age < 35 years.

  • Fit to receive adjuvant radiation +/- chemotherapy (if indicated) +/- hormonaltherapy (if indicated)

  • Written, informed consent

Exclusion

Exclusion Criteria:

  • Any pTis/3/4, M1 patients

  • Patients who have any pathologically involved axillary nodes (micro-metastasis maybe allowed)

  • Patients who have undergone neoadjuvant systemic therapy.

  • Previous or concurrent malignancy other than non melanomatous skin cancer andcarcinoma 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 Design

Total Participants: 1022
Treatment Group(s): 1
Primary Treatment: Post Mastectomy Radiation therapy
Phase:
Study Start date:
May 27, 2016
Estimated Completion Date:
December 31, 2033

Connect with a study center

  • All India Institute of Medical Sciences

    New Delhi, Delhi 110029
    India

    Site Not Available

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

    New Delhi, Delhi 110017
    India

    Site Not Available

  • Kolhapur Cancer Centre Pvt Ltd

    Kolhapur, Maharashtra 416234
    India

    Site Not Available

  • Tata Memorial Centre

    Mumbai, Maharashtra 400012
    India

    Active - Recruiting

  • Bhagwan Mahaveer Cancer Hospital and Research Centre

    Jaipur, Rajasthan 302017
    India

    Site Not Available

  • Post Graduate Institute of Medical Education & Research

    Chandigarh, 160012
    India

    Active - Recruiting

  • Max Super Speciality Hospital, Shalimar Bagh

    Delhi, 110088
    India

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.