Regional Radiotherapy Omission in Low-Risk Node Positive Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter, Prospective, Observational Study of Regional Radiotherapy Omission in Node Positive Patients With RecurIndex Low-risk Breast Cancer
Overview
The purpose of this study is to determine whether certain patients can safely omit regional lymph node radiotherapy. These women must have hormone-sensitive, Her2-negative tumors, have 1-3 positive axillary nodes and have RecurIndex low-risk.
Primary outcome measures
- Local-regional recurrence rate [Time frame: 5 years]
Secondary outcome measures (8)
- Any first recurrence (AFR) [Time frame: 5 years]
- Local-regional recurrence free survival (LRFS) [Time frame: 5 years]
- Recurrence free survival (RFS) [Time frame: 5 years]
- Disease free survival (DFS) [Time frame: 5 years]
- Beast cancer specific mortality (BCSM) [Time frame: 5 years]
- Overall Survival (OS) [Time frame: 5 years]
- Patient life quality measurement [Time frame: 5 years]
- Patient life quality measurement [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years old, ≤ 70 years old.
- Eastern Cooperative Oncology Group (ECOG) ≤ 2.
- Postoperative pathology is clearly diagnosed as invasive breast cancer. Meet the clinical definition of low risk: ①Axillary lymph node micrometastasis (N1mic) or ②N1 patients who meet the following conditions at the same time,
a）Age ≥ 40 years old, b）Vascular tumor thrombus (LVI) negative or allow few positive LVI (excluding extensive or massive LVI), c）ER positive (ER ≥ 1%) and HER2 negative (HER2 expression negative or + by IHC, or 2+ but negative by FISH).
- Postoperative pathological diagnosis of axillary lymph node status is any of the following: a. Sentinel lymph node biopsy or axillary lymph node dissection for micrometastasis (N1mic), b. Sentinel lymph node biopsy for 1-2 lymph node macrometastasis (N1sln), c. Sentinel lymph node biopsy + axillary lymph node dissection or simple axillary lymph node dissection for 1-3 lymph node metastasis (N1).
- The patient must have sufficient primary fresh frozen specimens or post- paraffin tissue sections for RecurIndex testing.
- Patients must have RecurIndex low risk obtained from testing of breast tumor tissue from a core biopsy or from the surgical specimen.
- The primary tumor and breast undergo breast-conserving surgery or total resection ± breast reconstruction (autologous/prosthetic).
- There must be adequate systemic examination (such as chest X-ray, B- ultrasound, CT, etc.) within 3 months before randomization of radiotherapy to confirm that there is no distant metastasis.
- Preoperative or radiotherapy should be performed within 12 months of randomization and must have mammography and/or MRI to confirm that there is no contralateral breast cancer.
- At least 4 courses of adjuvant chemotherapy with anthracycline or taxane should be completed after surgery.
- Radiotherapy must be performed sequentially after the completion of adjuvant chemotherapy, starting no later than 8 weeks after the end of chemotherapy.
- No previous history of malignant tumors, except for basal cell carcinoma of the skin.
- Signed an informed consent form.
Exclusion criteria
- Postoperative radiotherapy was confirmed as T3-4, N0, N2-3, M1 lesion staging before enrollment.
- Receive any new adjuvant therapy before surgery, including chemotherapy, endocrine therapy, targeted therapy or radiation therapy.
- Patients who underwent total mastectomy and only sentinel lymph node biopsy.
- Have a history of contralateral breast cancer.
- History of chest radiotherapy.
- combined with severe heart, lung, liver, kidney, hematopoietic, neurological diseases, and mental illness.
- History of autoimmune diseases such as scleroderma or active lupus erythematosus.
- pregnant and lactating patients.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — Guangzhou
Identifiers
NCT: NCT07179744 · REOM