NCT03530696

T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer

A Single Arm Phase II Study to Evaluate Efficacy of T-DM1 With Palbociclib in the Treatment of Patients With Metastatic HER2 Positive Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multi-center, single arm, phase II study of T-DM1 with palbociclib in the treatment of patients with metastatic HER2-positive breast cancer. Hypotheses: Combination of T-DM1 with palbociclib improves progression free survival Primary objective: Progression free survival of the combination of T-DM1 with palbociclib Secondary objectives i) Response rates ii) Overall survival Correlative objectives i) Investigate predictive biomarkers of response in blood and archived tumor tissue ii) Investigate mechanisms of resistance for palbociclib in blood and tumor tissue

Conditions

• HER2-positive Breast Cancer
• Breast Cancer
• Breast Cancer Stage
• Recurrent Breast Cancer
• Metastatic Breast Cancer
• HER2 Positive Breast Carcinoma

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2018-12-06
• Primary completion: 2022-12-22
• Completion: 2022-12-22
• First posted: 2018-05-21
• Last updated: 2024-08-13
• Results posted: 2024-07-24

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study