Phase I Evaluating the Combination of Ribociclib+Capecitabine in Locally Advanced/Metastatic Breast Cancer HER2 Negative
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
The proposed study is a multicenter, open-label phase I trial, conducted in locally advanced
or metastatic breast cancer HER2 negative patients and divided into 2 parts:
- STEP 1: a dose escalation part (n= up to 30) to evaluate the safety profile and
pharmacokinetics and to define the MTD and RP2D to recommend in a phase II.
- STEP 2: an expansion cohort part to confirm the safety and tolerability of ribociclib
and capecitabine association on a longer follow-up, and to obtain preliminary evidence
of anti-tumor activity on two expanded cohorts of HR positive and HR negative patients.
Up to 14 patients in each cohort, taking into account patients already included in step
one at this DL, may be enrolled, for a total of 28 at the RP2D.