Postoperative radiotherapy options for breast cancer patients

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 multicenter, randomized phase 3 clinical trial investigates the effectiveness of postoperative radiotherapy in patients with breast cancer. Participants will be randomly assigned to either receive postmastectomy radiation therapy (PMRT) or whole breast irradiation plus regional radiotherapy (WBI+regional RT), or to a group that does not receive these treatments. The study aims to determine if there is no significant difference in the 7-year disease-free survival rate between the two groups, stratifying by type of surgery and histologic type. The trial includes patients aged 19 and older who have undergone surgery for invasive breast cancer and have specific nodal involvement.

Why it matters

Who can join: the full rules

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 resected in the case of 1 positive node, and axillary lymph node dissection (ALND) should be performed in case of 2 or 3 positive nodes.
* Patients undergoing or planning to undergo hormone therapy in the case of hormone receptor positive.
* Patients who have received or are expected to undergo targeted therapy in the case of human epidermal growth factor receptor(HER)-2 positive.
* Patients with Eastern Cooperative Oncology Group (ECOG) Scale 0-2.
* Patients who agreed to participate in the study.

Exclusion Criteria:

* Patients who have received prior \[neoadjuvant\] chemotherapy.
* Patients receiving radiation therapy for salvage or palliative purposes.
* Patients with stage T4.
* Patients with ipsilateral supraclavicular and internal mammary lymph node metastases or distant metastases.
* Male breast cancer patient.
* Patients who have previously received radiation therapy to the ipsilateral breast or supraclavicular region.
* Patients having a history of cancer other than thyroid cancer, cervical carcinoma in situ, or skin cancer.
* Patients diagnosed with ductal breast carcinoma in situ, lobular carcinoma in situ, phyllodes, metaplastic cancer, or benign tumors based on histological diagnosis.

Where it's running

• Seoul National University Hospital
  Seoul, Jongro-gu, South Korea Recruiting

Study contacts

• Principal investigator: Kyung Hwan Shin, MD. PhD. — Seoul National University Hospital
• Study coordinator: Kyung Hwan Shin, MD. PhD.
• Email: radiat@snu.ac.kr
• Phone: +82-2-2072-2524

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Level I–II axillary radiation versus whole regional nodal radiation after surgery for breast cancer with 1–2 sentinel-node macrometastases.

  This will test whether limiting radiation to level I–II axillary lymph nodes works as well as whole regional nodal radiation for women with early breast cancer and 1–2 sentinel-node macrometastases.

  Recruiting Fudan University · Guiyang, Guizhou and 14 other locations · NCT07469267

• Breast radiotherapy using active breath hold to reduce heart exposure

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  Recruiting Fondazione IRCCS Policlinico San Matteo di Pavia · Pavia, Lombardy · NCT07299812

• Radiation with new targeted and immune drugs for metastatic breast cancer

  This project will see how well radiation is tolerated when given at the same time as newer systemic drugs (targeted therapies, antibody‑drug conjugates, TKIs, or immunotherapy) in people with stage IV breast cancer.

  Recruiting Fondazione Policlinico Universitario Campus Bio-Medico · Rome, Italy · NCT07021911

• Using radiation therapy before chemotherapy for Luminal B breast cancer

  This study is testing if giving radiation therapy before chemotherapy can help women with Luminal B breast cancer have better results before surgery.

  Recruiting IRCCS Azienda Ospedaliero-Universitaria di Bologna · Bologna · NCT05673304

• Analysis of outcomes and side effects in patients receiving radiation therapy

  This study looks at the results and side effects of radiation therapy in patients at Winterthur Cantonal Hospital to see how treatment can be improved for future patients.

  Recruiting Kantonsspital Winterthur KSW · Winterthur, Canton of Zurich · NCT05192876

• Comparing two types of radiation therapy for breast cancer patients

  This study is testing which type of radiation therapy works better for breast cancer patients with positive lymph nodes to help them stay cancer-free after surgery.

  Recruiting Phase 3 Fudan University · Shanghai, Shanghai Municipality · NCT05059379

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.