Evaluating post-mastectomy radiation for early breast cancer
Post-Mastectomy Radiation Therapy in High Risk, Node Negative Women With Early Breast Cancer (PMRT-NNBC)
This study tests if giving radiation after surgery can help women with early-stage breast cancer and certain high-risk factors avoid a return of their cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1022 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Tata Memorial Centre Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 7 sites (Chandigarh, Chandigarh and 6 other locations) |
| Trial ID | NCT02992574 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women with unilateral pT1,2N0M0 breast cancer or multifocal breast cancer with specific high-risk factors.
Not a fit: Patients with advanced breast cancer (pTis/3/4, M1) or those with positive axillary nodes are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment approach that reduces recurrence rates and improves survival for women with early breast cancer who have negative lymph nodes but present with high-risk factors.
How similar studies have performed: Previous studies have shown varying outcomes for similar approaches, but this specific evaluation of PMRT in node-negative patients with high-risk factors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chandigarh, Chandigarh and 6 other locations
- Post Graduate Institute of Medical Education & Research — Chandigarh, Chandigarh, India (Recruiting)
- Kolhapur Cancer Centre Pvt Ltd — Kolhāpur, Maharashtra, India (Not_yet_recruiting)
- Tata Memorial Centre — Mumbai, Maharashtra, India (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)
- Bhagwan Mahaveer Cancer Hospital and Research Centre — Jaipur, Rajasthan, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.