Clinical trial · Interventional
PQR309 and Eribulin in Metastatic HER2 Negative and Triple-negative Breast Cancer (PIQHASSO)
An 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eribulin | Drug | Eribulin | ALIAS |
| PQR309 | Drug | Bimiralisib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Eribulin and PQR309
- description
- 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.
- interventionNames
- Drug: PQR309
- Drug: Eribulin
Primary outcomes (2)
- measure
- Number of patients with treatment related Adverse Events and Serious Adverse Events as assessed by NCI CTCAEV4.03
- timeFrame
- Up to 6 months
- description
- Continous dosing and intermittent schedules of PQR309
- measure
- 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)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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: * 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.
References
Publications (0)
Data not yet available