Comparing two types of radiation therapy for breast cancer patients
A Multicenter Randomized Controlled Phase III Study of Medial vs. Entire Supraclavicualr Lymph Node Radiation Therapy for Patients With Pathologically Positive Axillary Lymph Node and High Risk of Recurrence After Breast Cancer Surgery
PHASE3 · Fudan University · NCT05059379
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.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1650 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Fudan University (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05059379 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with newly diagnosed invasive breast cancer who have undergone surgery and have positive lymph nodes.
Not a fit: Patients with early-stage breast cancer or those who have not undergone surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved disease-free survival and overall survival for breast cancer patients at high risk of recurrence.
How similar studies have performed: Previous studies have shown varying results regarding the effectiveness of different radiation techniques, making this approach both relevant and necessary for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
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Where this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Radiotherapy, Complications, Effect of Radiation Therapy, breast cancer, supraclavicular lymph node, radiotherapy