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NCT Number: NCT02992574

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

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.

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Key information

Conditions

Breastcancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Post Graduate Institute of Medical Education & Research, Chandigarh, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Post Mastectomy Radiation therapy

Radiation

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

Primary outcomes

  1. Disease free survival

    Time frame: 5 years

    This will be measured using Kaplan Meier time to event analysis

Secondary outcomes

  1. Chest wall recurrence

    Time frame: 5 years

    This is the incidence of local recurrence in the chest wall

  2. Regional recurrence

    Time frame: 5 years

    This is the incidence of recurrence in the regional lymphatics

  3. Metastasis-free survival

    Time frame: 5 years

    This will be measured using Kaplan Meier time to event analysis

  4. Overall survival

    Time frame: 5 years

    This will be measured using Kaplan Meier time to event analysis

  5. Acute Morbidity of radiotherapy

    Time frame: 4 weeks from the start of radiotherapy

    RTOG Acute radiation morbidity scoring

  6. Late Morbidity of radiotherapy

    Time frame: 6 months from end of radiotherapy to 5 years

    RTOG Late radiation morbidity scoring

  7. Quality of life scores under different domains of the QLQ C-30 and BR-23 questionnaires

    Time frame: 5 years post surgery

    Quality of life will be assesses by EORTC QLQ C-30 core questionnaire and the breast cancer specific module BR-23 questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Tabassum Wadasadawala, MBBS,MD,DNB

CONTACT

[email protected]

02227405078

Sponsors and collaborators

Lead sponsor

Tata Memorial Centre

Other

Registry information

Official study title

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

Acronym: PMRT-NNBC

Important dates

Study start
2016
Primary completion
2028
Study completion
2033
First posted
Dec 14, 2016
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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