Vinorelbine With Trastuzumab Emtansine in Pre-Treated HER2-Positive Metastatic Breast Cancer

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT02658084
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Vinorelbine — DRUG
    Administered as an intravenous infusion on Day 1 and Day 8 of every 21-day cycle.
  • Trastuzumab Emtansine — DRUG
    Administered as an intravenous infusion on Day 1 of every 21-day cycle.

Study Details

The study proposes to evaluate the safety and efficacy of the combination of trastuzumab emtansine (T-DM1) and vinorelbine in HER2+ metastatic breast cancer patients.

Key Dates

First listed
Jan 18, 2016
Start date
Apr 12, 2017
Status verified
Apr 2019
Primary completion
Oct 11, 2018
Completion
Oct 11, 2018

Study Design

Enrollment
2 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1: T-DM1 + Vinorelbine
    One cycle of Trastuzumab Emtansine (T-DM1)/Vinorelbine combination treatment is defined as 21-days (i.e. 3 weeks). The recommended (starting) dose of trastuzumab emtansine is 3.6 mg/kg given as an intravenous infusion on Day 1 of every 21-day cycle. The starting dose of Vinorelbine is 22.5 mg/m2 given as a direct intravenous push over 6-10 minutes on day 1 and day 8 of every 3-week (i.e. 21-day) cycle. Participants will be treated until documented disease progression or other criteria for discontinuation. Approximately 15 to 21 patients will be needed to establish the recommended phase II dose (RP2D).
  • Experimental: Phase 2: T-DM1 + RP2D Vinorelbine
    One cycle of trastuzumab emtansine (T-DM1)/vinorelbine combination treatment is defined as 21-days (i.e. 3 weeks). Participants will receive the recommended Phase 2 Dose (RPSD) of Vinorelbine with the fixed dose (3.6 mg/kg) of Trastuzumab Emtansine. Participants will be treated until documented disease progression or other criteria for discontinuation. Up to 35 patients will be treated at the RP2D (MTD) including 6 patients treated at RP2D in phase I.

Primary Outcome Measure

Phase 1 - Maximum Tolerated Dose (MTD) of Vinorelbine in Combination With a Fixed Dose of Trastuzumab Emtansine. [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136-

Find similar trials in Miami, FL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Miami· Miami, FL

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