Status:
NOT_YET_RECRUITING
Necessity of Post-mastectomy Radiotherapy After Neoadjuvant Chemotherapy and Mastectomy
Lead Sponsor:
Gangnam Severance Hospital
Conditions:
Breast Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
Postoperative radiotherapy is generally recommended for patients with breast cancer who have undergone breast-conserving surgery, regardless of prior chemotherapy. However, the criteria for postoperat...
Eligibility Criteria
Inclusion
- Patients 20 years of age or older with histologically confirmed invasive breast cancer.
- Patients with clinical stage IIB-III at the time of diagnosis (including cases of cT1N1 with multiple masses observed during clinical stage IIA). Patients are considered node positive if they have either suspected lymph node metastasis on imaging studies (U/S, breast MRI, PET-CT) or confirmed by pathology.
- Patients who have undergone mastectomy after prior neoadjuvant chemotherapy.
- Patients with pathologic complete response (pCR) or residual cancer burden (RCB) class 0-I based on postoperative pathology.
- Complete remission is defined as ypT0/is ypN0. RCB class 0 means complete remission and RCB class 1 is defined as an RCB score ≥0-1.36 as determined by the pathology department at the site.
- Patients not previously treated for invasive breast cancer.
- Patients with a systemic performance status of 0-2 based on ECOG.
- Patients who signed the informed consent prior to study entry.
Exclusion
- Patients with a prior history of invasive breast cancer (patients with a prior history of intraepithelial carcinoma of the breast may be enrolled)
- Patients with bilateral breast cancer
- Patients with a prior diagnosis of cancer other than breast cancer within 5 years (however, adequately treated skin cancer other than melanoma and thyroid cancer are eligible for enrollment.)
- Patients with pathologically or imaging confirmed systemic metastases
- Patients with a history of prior irradiation or isotope therapy to the rib cage and axillary region contralateral to the breast cancer lesion
- Patients with suspected supraclavicular/infraclavicular lymph node metastases and internal mammary lymph node metastases
- Pregnant or lactating patients
- Patients who have difficulty understanding the contents of the consent form and completing the survey.
Key Trial Info
Start Date :
November 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 10 2031
Estimated Enrollment :
1314 Patients enrolled
Trial Details
Trial ID
NCT05993559
Start Date
November 11 2024
End Date
July 10 2031
Last Update
January 12 2024
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