NCT02139358 - Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 5, 2014

Primary Completion Date

April 24, 2018

Study Completion Date

March 16, 2020

Conditions

Breast Cancer

Interventions

DRUG

Gemcitabine

The Phase I trial will start at the recommended phase II dose (RP2D) for gemcitabine but will have a de-escalation dose levels in the event that an unacceptable toxicity requires dose reduction. Dose level 0 = gemcitabine (1200 mg/m2) IV D1,8 q21 days; Dose level -1 = gemcitabine (1000 mg/m\^2) IV D1,8 q21 days; Dose level -2 = gemcitabine (850 mg/m\^2) IV D1,8 q21 days. The RP2D will be the dose level where 0-1 dose limiting toxicities (DLTs) in six patients occur.

DRUG

Trastuzumab

Trastuzumab will be given using an 8 mg/kg loading dose on cycle one, day one (C1D1), followed by 6 mg/kg IV on subsequent cycles every (q) 21 days.

DRUG

Pertuzumab

Pertuzumab will be given using an 840 mg IV loading dose on C1D1, followed by 420 mg IV on subsequent cycles q 21 days.

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa