An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer.

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT02657343
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ribociclib — DRUG
  • T-DM1 — DRUG
  • Trastuzumab — DRUG
  • Fulvestrant — DRUG

Study Details

Participants that have breast cancer that has spread to other parts of the body, is positive for a protein called HER2, and has not responded to standard treatment. This research study is a way of gaining new knowledge about the combination of Ribociclib with other drugs as a possible treatment for this diagnosis.

Key Dates

Start date
Mar 9, 2016
Status verified
Jul 2022
Primary completion
Aug 27, 2020
Completion
Jun 30, 2022

Study Design

Enrollment
25 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: Ribociclib + T-DM1 [3+3 Design]
    * Ribociclib will be given orally once day (day 5-18) at a pre-determine dose for two weeks of a 21 day cycle. During dose escalation, patients received doses of ribociclib of Period 1: 300 mg (n = 3), Period 2: 400 mg (n = 3), Period 3: 500 mg (n = 3), and Period 4: 600 mg (n = 3). Maximum dose-escalation of Ribociclib will be up to 600 mg. Dose-escalation will stop if DLT exceed limit. * T-DM1 will be given as IV infusions on Day 1 of a 3 week cycle at a pre-determined dose over pre-determined period of time.
  • Experimental: Cohort B: Ribociclib + Trastuzumab [Phase 1b/2 Study]
    * Ribociclib will be given orally once day (400 mg per day on a continuous schedule) for a 21-day cycle of treatment. * Trastuzumab will be given as IV infusions over 6 mg/kg every 3 weeks.
  • Experimental: Cohort C: Ribociclib + Trastuzumab + Fulvestrant [Phase 1b/2 Study]
    * Ribociclib will be given orally once a day continuously for a 28-day cycle of treatment (except at Dose Level -1, when Ribociclib is given Days 1-21 of a 28 day cycle). * Trastuzumab will be given as IV infusions over a pre-determined period of time and dose. Fulvestrant will be dosed approximately every 28 days as per standard of care.

Primary Outcome Measure

Cohort A: Recommended Phase2 Dose (RP2D) [ Time Frame: Disease was evaluated at baseline and each cycle on treatment and the end of treatment. Toxicity was evaluated each cycle on treatment, end of treatment and 30 days follow-up. Median treatment duration was 10.9 months with range 2.5 - 19.3 months. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massacusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Dana-Farber Cancer Institute· Boston, MAMassacusetts General Hospital· Boston, MA

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