None listed
Conditions
Interventions
Drug : The first part is a phase IB study to determine the RPIID (recommended phase II dose) of the ribociclib to be used in combination with letrozole 2.5 mg, trastuzumab (8 mg / kg followed by 6 mg
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Objective response rate, ORR;Duration of Response, DoR;Disease control rate, DCR;Quality of Life, QOL;Toxicity;biomarker analysis | — |
Countries
Korea, Republic of
Contacts
Public ContactJoohyuk Sohn
Yonsei University Health System, Severance Hospital
Outcome results
None listed