Durvalumab in Patients With HER-2 Positive Metastatic Breast Cancer Receiving Trastuzumab

Sponsor
Canadian Cancer Trials Group
Study ID
NCT02649686
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to find the highest dose of durvalumab that can be tolerated without causing very severe side effects when receiving standard treatment and to see what effects the study drug has on this type of cancer. The researchers doing this study are also interested in looking for markers that will help predict which patients are most likely to be helped by durvalumab when receiving standard treatment and what effects durvalumab has on this type of cancer.

Key Dates

Start date
May 17, 2016
Status verified
Apr 2020
Primary completion
Sep 25, 2017
Completion
Nov 12, 2019

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Durvalumab plus Trastuzumab
    Durvalumab q3w until PD Trastuzumab q3w x 6

Primary Outcome Measure

Confirm the recommended phase II dose of durvalumab given to patients with advanced/recurrent HER-2 positive metastatic breast cancer (MBC) who are receiving treatment with trastuzumab [ Time Frame: 18 months ]

Related Studies