Radiotherapy for N1 Breast Cancer After Surgery
The Postoperative Radiotherapy in N1 Breast Cancer Patients
Recruiting
Phase 3
Interventional Study
Radiotherapy
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 19 and older
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,106 (estimated)
- Sponsor
- Seoul National University Hospital · Other
Who this trial is looking for
This trial is looking for women with N1 stage breast cancer who have had surgery. Participants will be placed into two groups to see if additional radiation after surgery helps with survival rates.
Are You a Good Fit for This Trial?
You may be able to join if
- I am 19 years old or older.
- I have had surgery for invasive breast cancer.
- I have N1 stage breast cancer after surgery.
- I have had at least 5 nodes removed if I had one positive node.
- I am having or plan to have hormone therapy if my cancer is hormone receptor positive.
- I have received or expect targeted therapy if my cancer is HER-2 positive.
- I have an ECOG score of 0-2.
- I agree to participate in the trial.
You may not be able to join if
- I have had prior chemotherapy before surgery.
- I am receiving radiation therapy for other treatments.
- I have T4 stage breast cancer.
- I have lymph node metastases or distant metastases.
- I am a male.
- I have had previous radiation therapy to the same breast area.
- I have a history of other cancers except for certain types.
- I have been diagnosed with certain non-invasive breast conditions.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
This study is a multicenter, randomized, phase 3 clinical trial in patients with breast cancer, randomizing radiotherapy group (postmastectomy radiation therapy (PMRT)/whole breast irradiation plus regional radiotherapy (WBI+regional RT) versus and no PMRT/WBI alone group. This is a non-inferiority study aiming that there is no significant difference in the 7-year disease-free survival rate betwee…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patients aged 19 years or older.
* A female patient who underwent breast-conserving surgery or mastectomy for invasive breast cancer.
* Patient with stage pN1 after surgery on histopathologic examination.
* However, if mastectomy was performed, 5 or more nodes should be res…
Contacts