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T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer

NCT03530696 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2024-08-13

Study results available
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Summary

This is a single arm, phase II study to evaluate if the combination of T-DM1 with palbociclib improves progression-free survival in patients with metastatic HER2 positive breast cancer. All patients will be treated with T-DM1 with palbociclib.

Conditions

Interventions

DRUG

Palbociclib

Palbociclib is to be taken orally on days 5-18 (14 days) of each cycle (each cycle length is 21 days). The starting dose will be 125mg.

DRUG

T-DM1

The recommended dose of T-DM1 is 3.6 mg/kg and is given as an intravenous infusion on Day 1 of every cycle (every 21 days).

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • University of Arizona

    lead OTHER

Principal Investigators

  • Pavani Chalasani, MD · The University of Arizona Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-06
Primary Completion
2022-12-22
Completion
2022-12-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03530696 on ClinicalTrials.gov