CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Anastrozole +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02648477
NCT02648477Phase 2Completed

MK-3475 (Pembrolizumab) in Combination With an Anthracycline or Anti-estrogen Therapy in Patients With Triple Negative and Hormone Receptor Positive (HR+ HER2-) Metastatic Breast Cancer

City of Hope Medical Center·interventional·Posted Jan 7, 2016·Updated Mar 19, 2024

In Brief

A Phase 2 clinical trial evaluating Anastrozole, Doxorubicin Hydrochloride, and 4 other interventions for Estrogen Receptor Negative and 6 related conditions. Completed, enrolled 30 participants across 6 sites.

Detailed Summary

This phase II trial studies how well pembrolizumab and doxorubicin hydrochloride works compared to pembrolizumab with anti-estrogen therapy (anastrozole, letrozole, or exemestane) in treating patients with triple-negative or hormone-receptor positive breast cancer that has spread from the primary site (place where it started) to other places in the body. Pembrolizumab is an antibody drug that blocks a molecule called programmed death (PD)-1. PD-1 is a molecule that shuts down the body's immune responses and prevents the immune system from attacking the cancer. Doxorubicin hydrochloride is a drug used in chemotherapy that works to stop the growth of tumor cells by stopping them from dividing and by causing them to die. Anti-estrogen therapy, including anastrozole, letrozole, and exemestane, lowers estrogen levels in the body, which may help treat cancer that is hormone receptor-positive. Giving pembrolizumab together with standard treatment of either doxorubicin hydrochloride (triple-negative cancer) or anti-estrogen therapy (hormone receptor-positive cancer) may be an effective treatment for these types of breast cancer.

Study Details

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 7, 2016
Enrollment StartMar 28, 2016
Primary CompletionApr 1, 2022
Study CompletionDec 30, 2023
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 10.5 years ago

Interventions

Anastrozoledrug

Given PO

Doxorubicin Hydrochloridedrug

Given IV

Exemestanedrug

Given PO

Laboratory Biomarker Analysisother

Correlative studies

Letrozoledrug

Given PO

Pembrolizumabbiological

Given IV