Completed

PQR309 and Eribulin Combination Safety and Efficacy in HER2 Negative and Triple-Negative Breast Cancer

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

PQR309

+ Eribulin

Drug
Who is being recruted

Breast Diseases+3

+ Breast Neoplasms

+ Neoplasms

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: March 2016
See protocol details

Summary

Principal SponsorPIQUR Therapeutics AG
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 28, 2016

Actual date on which the first participant was enrolled.

This clinical trial focuses on treating locally advanced or metastatic HER2 negative and triple-negative breast cancer. The study aims to find the maximum safe dose of a new drug, PQR309, when combined with a standard dose of another drug, eribulin. This is important as it could lead to improved treatment options for patients with these types of breast cancer. The trial also seeks to evaluate the effectiveness of this drug combination specifically for those with triple-negative breast cancer. During the trial, participants will receive both PQR309 and eribulin. The study will first determine the safest continuous daily dose of PQR309 when used with eribulin. After this, the study will explore different intermittent schedules for taking PQR309, such as '2 days on/ 5 days off' or 'Monday / Thursday'. The effects of these treatments will be measured by monitoring the number of treatment-related side effects and how the patient's tumor responds to the treatment. The response will be categorized as complete response, partial response, or stable disease.

Official TitleAn Open Label, Non Randomized, Multicenter Phase 1/2b Study Investigating Safety and Efficacy of PQR309 and Eribulin Combination in Patients With Locally Advanced or Metastatic HER2 Negative and Triple-Negative Breast Cancer
NCT02723877
Principal SponsorPIQUR Therapeutics AG
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

41 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Criteria

5 inclusion criteria required to participate
Triple-negative breast cancer defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0,1+ or 2+ER and PR status <10% by local laboratory testing.
Histologically/cytologically confirmed diagnosis of breast cancer. Radiological evidence of inoperable locally advanced or metastatic breast cancer.
HER2 negative breast cancer (based on the most recent analyzed biopsy) defined as a negative in situ hybridization test or an immunohistochemistry status of 0, 1+ or 2+.
Received at least 2 and no more than 5 prio chemotherapeutic regimens in locally advanced and/or metastatic setting.
Show More Criteria
6 exclusion criteria prevent from participating
Previous systemic treatment with PI3K,mTOR or AKT inhibitors (allowed in the escalation part).
Previous treatment with eribulin (allowed in the escalation part).
Known hypersensitivity to any of the excipients of PQR309 or eribulin.
Concurrent treatment with other approved or investigational antineoplastic agent.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
PQR309 in combination with standard approved dose of eribulin mesylate 1.4 mg/m2 intravenous (iv) on days 1 and 8 in a period of 21 days per cycle will be investigated. . PQR309 will be administered maximum 15 minutes after eribulin iv dosing.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Suspended

Hospital Universitarsi Vall d'Hebron

Barcelona, SpainOpen Hospital Universitarsi Vall d'Hebron in Google Maps
Suspended

Insitut Català d´Oncologia

Barcelona, Spain
Suspended

Fundación Instituto Valenciano de Oncología

Valencia, Spain
Suspended

Barts Cancer Institute

London, United Kingdom
Completed5 Study Centers
PQR309 and Eribulin Combination Safety and Efficacy in HER2 Negative and Triple-Negative Breast Cancer | PatLynk