KCT0008323
Active, not recruiting
未知
Phase II study of Neo-adjuvant chemotherapy with letrozole in patients with estrogen receptor positive/HER-2 negative breast cancer
ational Cancer Center0 sites114 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ational Cancer Center
- Enrollment
- 114
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1 Locally advanced breast cancer patients with histological confirmation
- •2 Age \=19 and \=70
- •3 ER or PR positive, cT2N0 or cTx/N\+ M0 (ER\-positive \=1% nuclear staining by immunohistochemistry , Allred score\=3 )
- •4\. Histological specimen (FFPE) should be present at diagnosis, and when examined from a different hospital, slides for ER, PR, HER2, and KI67 immunohistochemistry analysis as well as 5 unstained slides need to be present
- •5\. Patients has hitologically and/or cytologically confirmed diagnosis of HER2\-negative breast cancer
- •6 Patients with at least one measurable lesion by RECIST 1\.1 from the images
- •7\. Women of childbearing age should agree to proper contraception during the trial period (from the beginning until a few hours or a few days after the last administration of drugs considering half\-life)
- •8 Patients with ECOG activity of 0,1, or 2
- •9 Patients with proper organ functions (attachment A)
- •10 Patients who signed the consent form
Exclusion Criteria
- •1\. Patients with inflammatory breast cancer
- •2\. Patients with bliateral breast cancer
- •3\.Patients with stroke including transient ischemic attack, pulmonary artery thrombosis or deep vein thrombosis untreated within 6 months: study participation is available when there are no symptoms after the administration of therapeutic anticoagulant for 6 weeks or longer within 6 months
- •4\. Patients with a history of previous malignant tumor. However, the following patients are exempted from the exclusion criteria
- •4\.1 Patients with 3 years of disease free survival with malignant tumor different from the current tumor
- •4\.2 Patients with skin tumor excluding melanoma that had complete resection
- •4\.3 Patients with early gastric cancer that had radical resection
- •5\.Patients with differentiated thyroid cancer of less than 1 cm
- •6\. Patients whose ejection fraction is less than 55% in the MUGA scan /EchoCG
- •7\. Patients without properly conserved tissue samples for diagnostic histological analysis (5 unstained slides excluding ER, PR, HER2, KI67\)
Outcomes
Primary Outcomes
Not specified
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