Phase IB & II study of Ribociclib with Trastuzumab plus Letrozole in Postmenopausal HR+, HER2+ Advanced Breast Cancer Patients

Yonsei University Health System, Severance Hospital0 个研究点目标入组 96 人开始时间: 待定最近更新: 2019年10月7日

试验速览

暂无简介。

•1. Patients aged =19 years
•2. Women with advanced (loco-regionally recurrent or metastatic) breast cancer not amenable for curative therapy
•3. Histologically and/or cytologically confirmed estrogen receptor positive and/or progesterone receptor positive breast cancer
•4. HER2 positive breast cancer (IHC 3+ or IHC 2+ and FISH, SISH or CISH+)
•5. Postmenopausal patient defined as either one of the following.
•- Prior bilateral ovariectomy
•- Age = 60 years old
•- Age <60 years and amenorrhea over 12 months (without chemotherapy, tamoxifen, toremifen or ovarian inhibition), FSH and estradiol are in the postmenopausal range according to local normal range
•6. Patients who were not previously treated with systemic treatment for advanced / metastatic breast cancer
•7. ECOG performance status 0 or 1
•8. Measurable or evaluable lesion according to RECIST v1.1
•9. Normal organ function defined as
•- ANC (absolute neutrophil count) = 1.5 × 109/L
•- Platelet = 100 × 109/L
•- Serum Hb = 9.0 g/dL
•- INR =1.5
•- Serum creatinine = 1.5 X ULN
•- ALT & ALT < 2.5 X ULN (in the absence of liver metastasis) or ALT & ALT < 5 X ULN (with liver metastasis)
•- Total serum bilirubin < 1.5 X ULN
•10. Left Ventricular Ejection Fraction (LVEF) within normal range
•11. Voluntary agreement on clinical trials

•1. Patients who have previously received CDK4 / 6 inhibitors or who have received other systemic treatments for advanced / metastatic breast cancer (Previous neo-adjuvant of adjuvant trastuzumab or aromatase inhibitor is not allowed, unless
•(1) Disease free interval was more than 12 months from the last dose of adjuvant trastuzumab or
•(2) Adjuvant aromatase inhibitor was administered more than 2 years)
•2. Inflammatory breast cancer
•3. Central nervous system metastasis
•4. Active cardiac disease or a history of cardiac dysfunction including any of the following (Congestive heart failure within 6 months, history of myocardial infarction, unstable angina pectoris, or QTc prolongation on electrocardiogram)
•5. Gastrointestinal absorption disorders that interfere with drug absorption
•6. Patients who is currently receiving medications that can prolong QT intervals (QTc>450msec) on ECG or that can cause torsades de pointes
•7. Patients with severe visceral metastasis on enrolment who are not indicated with hormone treatment
•8. Serious surgical treatment within 14 days prior to study treatment
•9. Radiotherapy within 21 days prior to study treatment
•10. Serious medical comorbidities
•11. Concurrent malignancy or malignancy within 3 years of study participation, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.

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