KCT0003346
Recruiting
未知
A Phase II Randomized Study of Palbociclib in combination with Exemestane plus GnRH agonist versus Capecitabine in Premenopausal Women with Hormone Receptor-Positive Metastatic Breast Cancer
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Samsung Medical Center
- Enrollment
- 182
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) A histologically proven metastatic breast cancer patient with measurable or evaluable lesion
- •2\) Diagnosis of stage 4 breast cancer (de novo) or recurrence after metastatic breast cancer for cure: metastatic breast cancer is not only distant metastasis but locally advanced state Also included.
- •3\)age \= 19 years
- •4\)ECOG performance status 0 – 2
- •5\) HER\-2 negative breast cancer (immunohistochemical staining (IHC score: 0\-1 or 2\) with negative HER2\-SISH (or FISH, CISH) test) and hormone receptor positive breast cancer (ER) positive or progesterone receptor (PgR) \-positive breast cancer in IHC (IHC)
- •6\) Women before menopause. Premenopausal status is defined as one of the following:
- •A. If you have had a last menstrual period within the last 12 months
- •B. Serum FSH should be below 40 IU / l if tamoxifen is used within 3 months.
- •C. For amenorrhea induced by chemotherapy, serum FSH should be below 40 IU / l.
- •7\) Patients may participate in this clinical trial if they have the following history of treatment.
Exclusion Criteria
- •1\)Postmenopausal women
- •2\)Serious uncontrolled intercurrent infections
- •3\)Serious medical and psychiatric illnesses not controlled including active heart disease within 6 months of myocardial infarction, angina, uncontrolled arrhythmia
- •4\)Pregnancy or breast feeding
- •5\)Second primary malignancy(except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or resected thyroid papillary carcinoma or other malignancy treated at least 5 years previously with no evidence of recurrence)
- •6\)Patients has received previous aromatase inhibitors and/or exemestane in the metastatic setting
- •7\)Patients has received previous treatment with CDK 4/6 inhibitors, PIK3CA inhibitor. MTOR inhibitor or capecitabine
- •8\) Symptomatic visceral metastasis : lymphangitic lung metastasis and/or hepatic metastasis
- •9\)Known CNS metastases in spite of treated and stable
- •10\) Clinically significant history of liver disease, current active abuse of alcohol or known active infection with hepatitis B virus or hepatitis C virus
Outcomes
Primary Outcomes
Not specified
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