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Official title Trial Evaluating Role of Post Mastectomy Radiotherapy in Women With Node Negative Early Breast Cancer
ClinicalTrials.gov ID: NCT02992574
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80, women only
You may be able to join if
- Women with unilateral pT1,2N0M0 breast cancer or multifocal breast cancer if largest discrete tumour at least 2cm or if the tumour area comprises...
- 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...
- Fit to receive adjuvant radiation +/- chemotherapy (if indicated) +/- hormonal therapy (if indicated)
- Written, informed consent
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chandigarh, Chandigarh, India
- Kolhāpur, Maharashtra, India
- Mumbai, Maharashtra, India
- Delhi, National Capital Territory of Delhi, India
- New Delhi, National Capital Territory of Delhi, India
- Jaipur, Rajasthan, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandigarh, Chandigarh, India; Kolhāpur, Maharashtra, India; Mumbai, Maharashtra, India; Delhi, National Capital Territory of Delhi, India; New Delhi, National Capital Territory of Delhi, India; Jaipur, Rajasthan, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.