Evaluating post-mastectomy radiation for early breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the effectiveness of post-mastectomy radiotherapy (PMRT) in women with early-stage breast cancer who have negative lymph nodes. It focuses on patients with specific high-risk factors that may increase their likelihood of recurrence despite having node-negative disease. The study aims to determine if PMRT can improve outcomes for these patients compared to those who do not receive radiation. Participants will undergo total mastectomy followed by the potential administration of adjuvant radiation therapy based on their individual risk profiles.

Why it matters

Who can join: the full rules

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

Where it's running

• Post Graduate Institute of Medical Education & Research
  Chandigarh, Chandigarh, India Recruiting
• Tata Memorial Centre
  Mumbai, Maharashtra, India Recruiting
• Kolhapur Cancer Centre Pvt Ltd
  Kolhāpur, Maharashtra, India Not yet recruiting
• Max Super Speciality Hospital, Shalimar Bagh
  Delhi, National Capital Territory of Delhi, India Not yet recruiting
• Max Super Speciality Hospital(A unit of Devki Devi Foundation)
  New Delhi, National Capital Territory of Delhi, India Not yet recruiting
• All India Institute of Medical Sciences
  New Delhi, National Capital Territory of Delhi, India Not yet recruiting

Study contacts

• Principal investigator: Tabassum Wadasadawala, MBBS,MD,DNB — Assistant Professor, Radiation Oncology, Tata Memorial Centre
• Study coordinator: Tabassum Wadasadawala, MBBS,MD,DNB
• Email: twadasadawala@actrec.gov.in
• Phone: 02227405078

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.