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

Launched by TATA MEMORIAL CENTRE · Dec 13, 2016

Keywords

ClinConnect Summary

This clinical trial is studying the effects of post-mastectomy radiotherapy (PMRT) in women with early-stage breast cancer who do not have cancer spread to their lymph nodes (node negative). The goal is to see if adding radiation therapy after surgery can lower the chances of cancer coming back and improve the time women live without the disease. While PMRT is known to help women with certain types of breast cancer that have spread to lymph nodes, it’s not usually recommended for those without node involvement. However, this trial aims to explore whether women with specific high-risk features may benefit from radiation.

To participate in this trial, women should be aged between 65 and 74 and have early-stage breast cancer that meets certain criteria, such as having a tumor that is larger than 2 cm. They also need to have undergone a total mastectomy and have no cancer in their lymph nodes. Participants will receive information and support throughout the trial, including the possibility of additional treatments like chemotherapy or hormone therapy if needed. This trial is currently recruiting participants, and those interested must provide written consent to join.

Gender

FEMALE

Eligibility criteria

• 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