Comparing two types of radiation therapy 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 phase III trial investigates the effectiveness of medial versus entire supraclavicular lymph node radiation therapy in patients with invasive breast cancer who have positive lymph nodes and are at high risk for recurrence after surgery. Patients will be randomized into two groups: one receiving medial supraclavicular radiation and the other receiving entire supraclavicular radiation. The primary objective is to evaluate disease-free survival, while secondary objectives include overall survival, recurrence rates, and assessment of radiation-related toxicities and quality of life. The trial aims to clarify the optimal radiation approach to improve patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. ECOG 0-1
2. Newly diagnosed invasive breast cancer
3. Initial clincial diagonosis stage is T1-4, N0-3a/b, M0: If neoadjuvant chemotherapy was not administered: pathological stage is T1-3N2-3a/b, M0; If neoadjuvant chemotherapy was administered：clinical stage III or pathological stage is T1-4N1-3a/bM0.
4. Underwent breast conservative surgery or Mastectomy with or without breast reconstruction with clear negative margin. At least, axillary level I and level II should be cleared with ≥10 lymph node (including the number of sentinal lymph node) . Level III dissection and internal mamamry node dissection are not required, but may be performed at the discretion of the surgeon.
5. Should receive ≥6 cycles standard neoadjuvant and/or adjuvant chemotherapy (taxane and/or anthracycline based).
6. Enrolled on the trial within 12 weeks of the later of two dates: the final breast cancer surgical procedure or administration of the last cycle of cytotoxic chemotherapy.
7. For ER and/or PR positive patients, the duration of anticipated endocrine therapy should be≥5 year ; For HER2 postive patients, the duration of anticipated herceptin should be 1 year.
8. Writtern, informed consent.

Exclusion Criteria:

1. Initinal clinical diagnosis N3c (supraclavicualr node metastasis)
2. T4 or inflamed breast cancer with no good downstage by neoadjuvant chemotherapy
3. Distant metastasis
4. Bilateral breast cancer or previously contralateral breast cancer
5. Positve sentinal lymph node with no axillary dissection
6. ECOG ≥2
7. Could not tolerate chemotherapy and anti-HER2 target treatment
8. Active infectious
9. History of radiotherapy
10. Serious medical complcation
11. Breast cancer during pregnancy and lactation
12. Had simultaneousl or previous secondary malignancies, except for skin basal cell carcinoma and cervical carcinoma in situ.
13. Inaccessibility for follow-up

    \-

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Zhaozhi Yang, M.D — Fudan University
• Study coordinator: Zhaozhi Yang, M.D.
• Email: yzzhi2014@163.com
• Phone: 86 18017317126

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

  This project will see if using an Active Breathing Coordinator (ABC) for deep inspiration breath hold reduces radiation dose to the heart in adults with stage I–III breast cancer receiving radiotherapy.

  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

• Postoperative radiotherapy options for breast cancer patients

  This study is testing different types of radiation therapy after breast cancer surgery to see which helps patients live longer without their cancer coming back.

  Recruiting Phase 3 Seoul National University Hospital · Seoul, Jongro-gu · NCT05440149

• 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

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.