Comparison of clinical efficacy between letrozole + ribociclib vs. Fulvestrant + letrozole + ribociclib in Hormone receptor positive, HER2 negative metastatic breast cancer – a randomized, phase 2 study

Koera University Guro Hospital0 个研究点目标入组 202 人开始时间: 待定最近更新: 2023年5月2日

适应症

试验速览

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•Male or female = 19 years of age
•-Patients must have histologically confirmed estrogen receptor (ER) or progesterone receptor (PR) positive and HER2-negative invasive breast cancer, as defined by the 2010 and 2013 American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines
•-Patients must have metastatic or advanced inoperable disease : 1) De novo metastatic breast cancer, 2) Recurrent breast cancer diagnosed more than 12 months after completion of adjuvant endocrine therapy. Patients diagnosed with recurrent breast cancer within 12 months after completion of adjuvant tamoxifen treatment will be allowed.
•-Patients who did not receive any systemic treatment for their metastatic/recurrent breast cancer.
•-Patients who have measurable or evaluable lesions based on RECIST version 1.1 criteria.
•-Patients must have ECOG performance status = 2
•-Patients must sign and give written informed consent for this protocol in accordance with institutional guidelines
•-Patients should have adequate organ function within 21 days prior to the start of study treatment (cycle 1, day1).
•-Women of childbearing potential must have a negative urine or serum pregnancy test within 28 days prior to registration; women/men of reproductive potential must have agreed to use an effective contraceptive method for the course of the study through 150 days after the last dose of study medication.

•-Patients who received CDK4/6 inhibitor for their metastatic disease
•-Patients who experienced disease recurrence during adjuvant endocrine therapy with aromatase inhibitor
•-Uncontrolled CNS metastasis
•-Patients who are not adequate for endocrine therapy due to visceral crisis.

发起方

Koera University Guro Hospital