NCT01976169 (Clinical Trial/ Ado-Trastuzumab Emtansine)

Study Title
Phase 1b Study of PD-0332991 in Combination With T-DM1(Trastuzumab-DM1) (NCT01976169)

Trial Description
Standard of care:
Treatment with Trastuzumab

21-Day Cycle of Combination therapy with ado-trastuzumab emtansine (T-DM1, Kadcyla®; Genentech, Inc.) intravenously on Day 1 and oral PD-0332991 on Days 5-18

Study Design and Methodology:
This is a phase 1B inter-patient dose escalation study of PD-0332991 in combination with T-DM1 in patients with recurrent or metastatic HER2-positive breast cancer after prior trastuzumab or other HER2-directed therapies.

The subjects will be administered T-DM1 by intravenous infusion at 3.6 mg/kg for 90 minutes on day 1 of each 21 day cycle. Infusion timing may vary from 30-90 minutes depending on how well the subject tolerates the treatment.

A standard 3+3 trial design will be used for PD-0332991 dose escalation cohorts.The dosing of PD-0332991 will be divided into 3 cohorts, the subjects will receive PD-0332991 on days 5-18 of each 21 day cycle.

Cohort 1 : PD-0332991 – 100 mg daily (oral) Cohort 2 : PD-0332991 – 150 mg daily (oral) Cohort 3 : PD-0332991 – 200 mg daily (oral)

The 3+3 design entails that if one patient out of the first three patients has a DLT, up to three additional patients will be entered at that dose level

Treatment cycles will continue until disease progression or withdrawal from study.

This trial is sponsored by University of Texas Southwestern Medical Center. [1]

Study Data

  • Condition: Advanced Breast Cancer
  • Interventions:
    • Drugs used in this trial
  • Phase: I
  • Estimated Enrollment: 17
  • Start: January 2014
  • Estimated Completion: August 2015
  • Last verified: May 2015

Study Schematic

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Last Editorial review: July 28, 2015
Information based on (NIH/NCI) and other sources.

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