Medial vs. Entire Supraclavicular Lymph Node Radiation Therapy for Patients With Invasive Breast Cancer (SUCLANODE)
Breast Cancer, Radiotherapy; Complications, Effect of Radiation Therapy
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, supraclavicular lymph node, radiotherapy
Eligibility Criteria
Inclusion Criteria:
- ECOG 0-1
- Newly diagnosed invasive breast cancer
- 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.
- 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.
- Should receive ≥6 cycles standard neoadjuvant and/or adjuvant chemotherapy (taxane and/or anthracycline based).
- 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.
- 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.
- Writtern, informed consent.
Exclusion Criteria:
- Initinal clinical diagnosis N3c (supraclavicualr node metastasis)
- T4 or inflamed breast cancer with no good downstage by neoadjuvant chemotherapy
- Distant metastasis
- Bilateral breast cancer or previously contralateral breast cancer
- Positve sentinal lymph node with no axillary dissection
- ECOG ≥2
- Could not tolerate chemotherapy and anti-HER2 target treatment
- Active infectious
- History of radiotherapy
- Serious medical complcation
- Breast cancer during pregnancy and lactation
- Had simultaneousl or previous secondary malignancies, except for skin basal cell carcinoma and cervical carcinoma in situ.
Inaccessibility for follow-up
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Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Breast/chest wall+undisseted axillary+IMN+medial SCL ( medial SCL radiation)
Breast/chest wall+undisseted axillary+IMN+entie SCL (entire SCL radiation)
Radiation is delivered to the breast/chest wall, undissected axilla, internal mammary nodes and medial supraclavicular node. Treatment will be given by normfractionated or hypofractionated radiotherapy (50Gy/25Fx/5w or 42.5Gy/16Fx/3.5w). IMRT and VMAT technique are recommended.
Radiation is delivered to the breast/chest wall, undissected axilla, internal mammary nodes and entire supraclavicular node. Treatment will be given by normfractionated or hypofractionated radiotherapy (50Gy/25Fx/5w or 42.5Gy/16Fx/3.5w). IMRT and VMAT technique are recommended.