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CompletedNCT02723877Updated Mar 22, 2019

PQR309 and Eribulin in Metastatic HER2 Negative and Triple-negative Breast Cancer (PIQHASSO)

A Phase 1/2 interventional study of PQR309 and Eribulin in Metastatic Breast Cancer, sponsored by PIQUR Therapeutics AG. Completed at 5 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-22.

Sponsored by PIQUR Therapeutics AG · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
41
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

This study is an open-label,non randomized, multi-center, phase 1/2b (dose escalation followed by expansion part) study evaluating clinical safety, efficacy and pharmacokinetics of PQR309 in combination with standard dose of eribulin in patients with locally advanced or metastatic HER2-negative (escalation part) and Triple Negative Breast Cancer (expansion part).

Read the detailed description
  • The primary objective of the escalation part is to assess the maximum tolerated dose (MTD) of PQR309 combined with the standard eribulin dose in patients with HER2 negative breast cancer following a "modified" 3 by 3 design.
  • For the expansion part the objective is to evaluate efficacy of PQR309 in combination with eribulin in patients with Triple Negative Breast Cancer
  • Once the MTD of continuous daily PQR309 dosing has been established, intermittent schedules of PQR309 ("2 days on/ 5 days off" or "Monday / Thursday") will be evaluated.
02

Conditions studied

  • Metastatic Breast Cancer

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Keywords

  • TNBC
03

In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's enrollment of 41 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

PIQUR Therapeutics AG is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.
  • Prior therapy has to include an anthracycline and a taxane in any combination or order.
  • For Expansion part:

Triple-negative breast cancer defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0,1+ or 2+ER abnd PR status \<10% by local laboratory testing.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • Symptomatic Central Nervous System metastases. The patient must have completed any prior local treatment for CNS metastases > 28 days prior to first dose of the study drug (including radiotherapy and/or surgery).
  • Clinically manifested diabetes mellitus(treated and/or clinical signs with fasting glucose >125mg/dl or HbA1c>7%), or documented steroid induced diabetes mellitus.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    Eribulin and PQR309

    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.

    Drug: PQR309 · Drug: Eribulin

Interventions

  • DrugPQR309

    Dual phosphatidylinositol 3-kinase phosphoinositide 3-kinase/ mammalian target of rapamycin Inhibitor (= PI3K/mTOR Inhibitor)

  • DrugEribulin

    non.taxane microtubule dynamics inhibitor

    Also known as: eribulin mesylate, Halaven®

06

What researchers measure

Primary outcomes

  1. Number of patients with treatment related Adverse Events and Serious Adverse Events as assessed by NCI CTCAEV4.03

    Continous dosing and intermittent schedules of PQR309

    Time frame: Up to 6 months

  2. RECIST the Response criteria for solid tumors will be used to identify clinical benefit rate (CBR) including complete Response (CR), partial Response (PR) and stable disease (SD)

    Continous dosing and intermittent schedules of PQR309

    Time frame: Up to 15 months

Secondary outcomes

  1. Number of patients with Adverse Events and Serious Adverse Events and number of anormal laboratory values that constitute an Adverse Events on their own

    Continous dosing and intermittent schedules of PQR309

    Time frame: Up to 12 months

  2. Number and percent of patients having each ECOG (Eastern Oncology Cooperative Group) performance status level will be presented for baseline and each post-baseline measurement.

    Continous dosing and intermittent schedules of PQR309

    Time frame: up to 12 months

  3. Assessment of PQR309 and Eribulin blood concentration

    Continous dosing and intermittent schedules of PQR309

    Time frame: up to 12 months

  4. Physical examination, Body weight in kg

    Continous dosing and intermittent schedules

    Time frame: up to 12 months

  5. Physical examination, ECG

    Continous dosing and intermittent schedules of PQR309

    Time frame: up to 12 months

  6. Vital signs like heart rate

    Continous dosing and intermittent schedules of PQR309

    Time frame: up to 12 months

  7. Vital signs like blood pressure

    Continous dosing and intermittent schedules of PQR309

    Time frame: up to 12 months

  8. Vital signs like body temperature

    Continous dosing and intermittent schedules of PQR309

    Time frame: up to 12 months

  9. Objective Response Rate (ORR), is defined as the best overall response (confirmed CR or PR) recorded for each patient since baseline.

    Continous dosing and intermittent schedules of PQR309

    Time frame: up to 12 months

  10. Time to Response (TTR) is defined, for patients with tumor response, as the time from the date of study entry to the first documentation of response (complete or partial)

    Continous dosing and intermittent schedules of PQR309

    Time frame: up to 12 months

  11. Duration of response (DOR) is defined, for the patients with tumor response, as the time from the date of the first confirmed response to disease progression.

    Continous dosing and intermittent schedules of PQR309

    Time frame: up to 12 months

  12. Progression- free survival (PFS) is defined as the time from study entry to progression or death due to any cause

    Continous dosing and intermittent schedules of PQR309

    Time frame: up to 12 months

  13. Time to treatment failure (TTF) is defined as the time from study entry to any treatment failure including disease progression or discontinuation of treatment

    Continous dosing and intermittent schedules of PQR309

    Time frame: up to 12 months

  14. 1-year survival, defined as the time from study entry to death as a result of any cause at 1-year cut-off date

    Continous dosing and intermittent schedules of PQR309

    Time frame: up to 12 months

  15. Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: tmax

    Intermittent schedule B: "Monday/ Thursday"

    Time frame: On Cycle 1 Day 8: pre-dose, end of eribulin infusion, 2h and 6h post end of eribulin infusion and on Day 15: pre-dose and one sample between 1 and 3 hours post PQR309 dose

  16. Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: cmax

    Intermittent schedule B: "Monday/ Thursday"

    Time frame: On Cycle 1 Day 8: pre-dose, end of eribulin infusion, 2h and 6h post end of eribulin infusion and on Day 15: pre-dose and one sample between 1 and 3 hours post PQR309 dose

  17. Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: AUC0-24

    Intermittent schedule B: "Monday/ Thursday"

    Time frame: On Cycle 1 Day 8: pre-dose, end of eribulin infusion, 2h and 6h post end of eribulin infusion and on Day 15: pre-dose and one sample between 1 and 3 hours post PQR309 dose

  18. Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: AUC0-∞

    Intermittent schedule B: "Monday/ Thursday"

    Time frame: On Cycle 1 Day 8: pre-dose, end of eribulin infusion, 2h and 6h post end of eribulin infusion and on Day 15: pre-dose and one sample between 1 and 3 hours post PQR309 dose

  19. Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: RAC(Racemate)

    Intermittent schedule B: "Monday/ Thursday"

    Time frame: On Cycle 1 Day 8: pre-dose, end of eribulin infusion, 2h and 6h post end of eribulin infusion and on Day 15: pre-dose and one sample between 1 and 3 hours post PQR309 dose

  20. Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: cmax

    Intermittent schedule A: 2 days on/5 days off

    Time frame: PK is being assessed during Cycle 1 on Day 8: pre-dose, end of eribulin infusion, 2h and 6h post end of eribulin infusion. On Cycle 1 Day 15: pre-dose and one sample between 1 and 3 hours post PQR309 dose.

  21. Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: tmax

    Intermittent schedule A: 2 days on/5 days off

    Time frame: PK is being assessed during Cycle 1 on Day 8: pre-dose, end of eribulin infusion, 2h and 6h post end of eribulin infusion. On Cycle 1 Day 15: pre-dose and one sample between 1 and 3 hours post PQR309 dose.

  22. Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: AUC0-24

    Intermittent schedule A: 2 days on/5 days off

    Time frame: PK is being assessed during Cycle 1 on Day 8: pre-dose, end of eribulin infusion, 2h and 6h post end of eribulin infusion. On Cycle 1 Day 15: pre-dose and one sample between 1 and 3 hours post PQR309 dose.

  23. PK parameters of PQR309 and eribulin will include: AUC0-∞

    Intermittent schedule A: 2 days on/5 days off

    Time frame: PK is being assessed during Cycle 1 on Day 8: pre-dose, end of eribulin infusion, 2h and 6h post end of eribulin infusion. On Cycle 1 Day 15: pre-dose and one sample between 1 and 3 hours post PQR309 dose.

  24. Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: RAC

    Intermittent schedule A: 2 days on/5 days off

    Time frame: PK is being assessed during Cycle 1 on Day 8: pre-dose, end of eribulin infusion, 2h and 6h post end of eribulin infusion. On Cycle 1 Day 15: pre-dose and one sample between 1 and 3 hours post PQR309 dose.

  25. Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: cmax

    Continous Dosing

    Time frame: It will be measured pre-dose and at the end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end and at end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end of eribulin during Cycle 1 on day 1 and 8 and beyond cycle 1 on day 1

  26. Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: AUC0-24

    Continous Dosing

    Time frame: It will be measured pre-dose and at the end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end and at end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end of eribulin during Cycle 1 on day 1 and 8 and beyond cycle 1 on day 1

  27. Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: AUC0-∞

    Continous Dosing

    Time frame: It will be measured pre-dose and at the end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end and at end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end of eribulin during Cycle 1 day on 1 and 8 and beyond cycle 1 on day 1

  28. Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: t1/2

    Continous Dosing

    Time frame: It will be measured pre-dose and at the end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end and at end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end of eribulin during Cycle 1 on day 1 and 8 and beyond cycle 1 on day 1

  29. Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: tmax

    Continous Dosing

    Time frame: It will be measured pre-dose and at the end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end and at end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end of eribulin during Cycle 1 on day 1 and 8 and beyond cycle 1 on day 1

  30. Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: RAC (Racemate)

    Continous Dosing

    Time frame: It will be measured pre-dose and at the end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end and at end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end of eribulin during Cycle 1 on day 1 and 8 and beyond cycle 1 on day 1

  31. Changes in glucose levels

    Continous dosing and intermittent schedules of PQR309

    Time frame: 12 months

  32. Changes in Insulin levels

    Continous dosing and intermittent schedules of PQR309

    Time frame: 12 months

  33. Changes of Routine laboratory -Haematology

    Continous dosing and intermittent schedules of PQR309

    Time frame: 12 months

  34. Changes of Routine laboratory -blood chemistry

    Continous dosing and intermittent schedules of PQR309

    Time frame: 12 months

  35. Changes of Routine laboratory -urinanalysis

    Continous dosing and intermittent schedules of PQR309

    Time frame: 12 months

07

Study locations

5 sites
  • Hospital Universitarsi Vall d'Hebron
    Barcelona, Catalan 08035, Spain
  • Insitut Català d´Oncologia
    Barcelona, Spain
  • Fundación Instituto Valenciano de Oncología
    Valencia, Spain
  • Barts Cancer Institute
    London, United Kingdom
  • Churchill hospital
    Oxford, United Kingdom
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2016 to primary completion in Oct 2018, 30 months.

Of 141 industry-sponsored phase 1/2 interventional studies under Breast Neoplasms, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 79. This study's 30 months is below that.

Counting every sponsor, half of 298 studies reached it within 61 months; a quarter within 44 and three quarters within 88.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 21, 2015
First posted
Mar 31, 2016
StartActual
Mar 28, 2016
Primary completionActual
Oct 3, 2018
CompletionActual
Oct 3, 2018
Last update
Mar 22, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02723877
Lead sponsor
PIQUR Therapeutics AG
Collaborators
Hospital Universitario Ramon y Cajal, Hospital Universitari Vall d'Hebron Research Institute, Institut Català d'Oncologia, Churchill Hospital, Barts Cancer Institute, Fundación Instituto Valenciano de Oncología
Responsible party
Sponsor
First posted
Mar 31, 2016
Start date
Mar 28, 2016
Primary completion
Oct 3, 2018
Completion
Oct 3, 2018
Last update
Mar 22, 2019

Study contacts

Javier Cortes, PD Dr. med
study director · Hospital Universitario Ramon y Cajal

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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