Breast Cancer Clinical Trial
— NeoChAIOfficial title:
Phase II Study of Neo-adjuvant Chemotherapy With Letrozole in Patients With Estrogen Receptor Positive/HER-2 Negative Breast Cancer
This is an exploratory interventional study that initiates chemotherapy with letrozole in patients with estrogen receptor positive/HER2-negative breast cancer preoperably.
Status | Recruiting |
Enrollment | 114 |
Est. completion date | January 2024 |
Est. primary completion date | November 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 19 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Pathologically proven breast cancer patients who are candidate of neoadjuvant chemotherapy with AC followed by Docetaxel - Age: 19-70 years - ER or PR positive ,cT2-3N0 or cT1-3/N+ M0 (ER-positive =1% nuclear staining by immunohistochemistry , Allred score=3 ) - Available FFPE tissue for biomarker study - HER2-negative by ASCO/CAP guideline - Patients who agree to adequate contraception - ECOG scores of 0-2 - Normal or acceptable kidney, liver, cardiovascular, and bone marrow functions - Patients who provide consent Exclusion Criteria: - Inflammatory breast cancer - Distant metastasis - Cerebral vascular accidents including transient ischemic attack - Pulmanary thromboembolism or deep vein thrombosis with 6 months; however, patients who received more than 6 weeks of anticoagulation within 6 months and remains asymptomatic are eligible. - With a history of malignant tumor or complicated with other malignant tumors in addition to breast cancer, except for non-melanoma skin cancer, curatively resected early gastric cancer, differentiated thyoid cancer < 1 cm, or other cured malignant tumor without recurrence for at least 3 years - Ejection Fraction <55% by MUGA scan / Echo CG - No available tissue for biomarker study - Pregnant or lactating women - Patients with other serious diseases or medical conditions: Pituitary adenoma, Malabsorption syndrome, Major resection of gastrointestinal tract, Corrected QT interval > 480 msec, Congestive heart failure or unstable angina pectoris, myocardial infarction, stent insertion, angioplasty, coronary bypass surgery, symptomatic peripheral artery disease within 6 months before the enrollment - NYHA class III or IV congestive heart failure - Uncontrolled hypertension and uncontrolled high-risk arrhythmia considered by the investigator - Major surgery, major trauma, and/or unhealed wound, fracture, or ulcer within 4 weeks - Acute hemorrhage or hemorrhagic tendency - Obvious neurological or psychiatric disorders, including psychosis, epileptic dementia and other diseases which may affect the understanding and sign of the informed consent - Uncontrolled acute infection - Patients with allergic constitution and any known or suspected drug allergy - Concurrent use of other investigational drugs; or participating in other clinical trials involving investigational drugs within 30 days before this study - Patients with mental illness or other conditions affecting the patient compliance - Not suitable for the trial considered by the investigator |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | National Cancer Center | Goyang-si |
Lead Sponsor | Collaborator |
---|---|
National Cancer Center, Korea |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pathologic complete remission (pCR) | pCR defined as no invasive residuals in breast and lymph nodes (ypT0/Tis, ypN0 [MD Anderson definition]) | within 6 weeks following the last dose of chemotherapy | |
Secondary | Adverse events | Frequency and severity of hematological and non-hematological adverse events and laboratory abnormalities according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0 | during 6 months of neoadjuvant chemotherapy | |
Secondary | Response rate | Overall objective clinical response rate = CR + PR rate, measured by MRI (or US) and assessed by RECIST criteria. | during 6 months of neoadjuvant chemotherapy | |
Secondary | Downstaging to breast conserving surgery (BCS) | Ratio of the number of patients with breast conserving surgery converted from planned mastectomy over the number of patients with initially planned mastectomy | within 6 weeks following the last dose of chemotherapy | |
Secondary | Disease free survival | Disease-free survival (DFS) following operation. | Patients will be followed up to 6 years |
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