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

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

RELAX is an open-label, multicenter, randomized non-inferiority phase 3 trial that enrolls clinically node-negative breast cancer patients with one to two sentinel lymph node macrometastases. Participants are randomized 1:1 to receive either level I–II axillary irradiation plus breast/chest wall radiation or entire regional nodal irradiation including levels I–III and supraclavicular nodes, with internal mammary node irradiation optional for medial/central tumors. The primary endpoint is disease-free survival, with secondary endpoints including overall survival, regional and distant recurrence, radiation-related toxicities, and quality of life. Radiation must start within 12 weeks of surgery or the last adjuvant chemotherapy dose, and systemic therapies are given per tumor receptor status.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Female ≥ 18 years of age;
2. Newly diagnosed primary invasive breast cancer;
3. Clinically stage T1-3N0M0;
4. Patients received surgery as first treatment,and have undergone breast conserving-surgery or mastectomy (with or without breast reconstruction) with negative margins;
5. Have one or two macrometastases (\>2 mm) at sentinel lymph node biopsy,and without further axillary lymph node dissection;
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
7. Will receive endocrine therapy for at least 5 years for estrogen receptor (ER) and/or progesterone receptor (PR) positive patients; will receive anti-HER2 (human epidermal growth factor receptor 2) therapy for 1 year for HER2 positive patients;
8. Radiation therapy must begin no later than 12 weeks after the last dose of adjuvant chemotherapy or the last breast cancer surgery if no adjuvant chemotherapy;
9. Patients have adequate organ function;
10. Acquirement of informed consent.

Exclusion Criteria:

1. Patients have received neoadjuvant systemic therapy;
2. Clinical stage T4 or IV (metastatic) breast cancer, or presence of regional metastases before surgery;
3. History of any prior ipsilateral or contralateral invasive breast cancer, history of other malignancies except for appropriately treated skin basal cell carcinoma and cervical carcinoma in situ;
4. History of previous radiotherapy towards the ipsilateral chest/lymph nodes.
5. The ipsilateral axillary lymph node dissection or other previous axillary surgery;
6. Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, or psychiatric disease), inability to tolerate radiotherapy or systemic therapy if indicated;
7. Current pregnancy and/or lactation;
8. Inability or unwillingness to comply with protocol requirements.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting
• Oncology Department, Guizhou Provincial People's Hospital
  Guiyang, Guizhou, China Not yet recruiting
• The Fourth Hospital of Hebei Medical University
  Shijiazhuang, Hebei, China Not yet recruiting
• Harbin Medical University Cancer Hospital
  Harbin, Heilongjiang, China Not yet recruiting
• Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Not yet recruiting
• Department of Radiation and Medical Oncology，Zhongnan Hospital of Wuhan University
  Wuhan, Hubei, China Not yet recruiting

Study contacts

• Principal investigator: Xiaoli Yu, MD, PhD — Fudan University
• Study coordinator: Xiaoli Yu, MD, PhD
• Email: xiaoliyu@fudan.edu.cn
• Phone: +86-13817893133

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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.