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Clinical Trials/KCT0004567
KCT0004567
Recruiting
未知

prospective cohort study to evaluate the effect of regional nodal irradiation omission on the regional recurrence rate after neoadjuvant chemotherapy followed by breast conserving surgery and sentinal lymph node biopsy in clinical T1-3 with lymph node metastasis in axillary level I and ypN0 breast cancer patient

ational Cancer Center0 sites844 target enrollmentTBD
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ConditionsNeoplasms

Overview

Phase
未知
Intervention
Not specified
Conditions
Neoplasms
Sponsor
ational Cancer Center
Enrollment
844
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational Study
Sex
Female

Investigators

Sponsor
ational Cancer Center

Eligibility Criteria

Inclusion Criteria

  • •1\. Ages eligible for study: between 20\-70 years old
  • •2\. Patient must have had pathologic confirmation of invasive breast cancer
  • •3\. The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of
  • •4\. Patient must have clinically T1\-3 (before neo\-adjuvant therapy)
  • •5\. Patient must have axillary level I nodal involvement at presentation (before neo\-adjuvant therapy) based on either a positive fine needle aspirate (FNA) or positive in positron emission tomography (PET) scan
  • •6\. Patients with metastatic lymph node at axilla level I only
  • •7\. Patient who have undergone breast conserving surgery
  • •8\. Patient who have undergone either sentinel lymph node biopsy or axillary lymph node sampling
  • •9\. Patients with pathologic staging of ypN0, ypN0(i\+) or ypN0(mol\+) are eligible (Note: postneo\-adjuvant therapy is designated with a yp prefix.)
  • •10\. Patients must have had estrogen receptor (ER), progesterone receptor (PR), HER2, and Ki\-67 index testing performed on the primary breast tumor before neo\-adjuvant therapy

Exclusion Criteria

  • •1\. T4 tumors including inflammatory breast cancer
  • •2\. Definitive clinical or radiologic evidence of metastatic disease
  • •3\. Patients with metastatic lymph node at axilla level II\-III, internal mammary and supraclavicular area by imaging
  • •4\. Patient must have not completed a minimum of 50% of standard neo\-adjuvant chemotherapy
  • •5\. Patients who showed progression during neo\-adjuvant chemotherapy
  • •6\. Patient who have undergone mastectomy
  • •7\. Patient who have undergone axillary lymph node dissection
  • •8\. Bilateral breast cancer patients
  • •9\. Male breast cancer patients
  • •10\. Prior breast or thoracic radiation therapy (RT) for any condition

Outcomes

Primary Outcomes

Not specified

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