Clinical trial · Interventional
Targeting Aurora A Kinase to Overcome Treatment Resistance in Advanced HR+/HER2+ Breast Cancer
Targeting Aurora A Kinase to Overcome Treatment Resistance in Advanced HR+/HER2+ Breast Cancer: A Biomarker-Driven Pilot Clinical Trial
NCT07706179CI-TRIAL-00124029not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to learn if alisertib in addition to usual care works to treat HR+/HER2+ breast cancer. The main questions it aims to answer are: * Does alisertib stop the communication between HR and HER2? * Are there genetic markers that predict how well someone's cancer will respond to alisertib? Participants will receive alisertib in addition to their usual care.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HR+/HER2+ Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alisertib | Drug | Alisertib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Alisertib plus standard of care
- description
- Participants receive alisertib in addition to usual care
- interventionNames
- Drug: Alisertib
Primary outcomes (3)
- measure
- Clinical benefit defined as partial tumor response (PR)
- timeFrame
- 12 weeks
- description
- As defined by RECIST 1.1. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
- measure
- Clinical benefit defined as complete tumor response (CR)
- timeFrame
- 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years at the time of consent. * ECOG performance status \</=2 (Karnofsky \>/=60%). * Metastatic HR+/HER2+ breast cancer (estrogen receptor (ER) and/or progesterone receptor (PR) ≥1%, HER2 3+ by immunohistochemistry (IHC) or amplified by in situ hybridization (ISH). * Prior standard induction treatment with chemotherapy + trastuzumab + pertuzumab (HP) or fam-trastuzumab deruxtecan (T-DXd) and have completed a minimum of 4 cycles without progressive disease. * Planned to start or are receiving endocrine therapy + HER2-directed (HP or pertuzumab/trastuzumab/hyaluronidase-zzxf (PHESGO®)) therapy. * Demonstrate adequate organ function; all screening labs to be obtained within 28 days prior to registration. * Left ventricular ejection fraction ≥ 50% as assessed by echocardiogram (ECHO) or multi-gated acquisition scan (MUGA) documented within 6 weeks prior to the study treatment. * Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors volume 1.1 (RECIST 1.1) or evaluable disease with circulating tumor DNA (ctDNA) that is detectible. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. * Willingness to receive growth factor injections for neutropenia prophylaxis. Only patients without any grade 3 or higher neutropenia during induction chemotherapy or T-DXd will be permitted to proceed without prophylactic growth factor support. If the enrolled patients in this trial develop high grade or prolonged neutropenia, the addition of growth factor will be required. Exclusion Criteria: * Active infection requiring systemic therapy. * Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial. * Treatment with any investigational drug within 14 days prior to registration, or within 5 half-lives of the investigational product, whichever is longer.
References
Publications (0)
Data not yet available
No reference posted for this study.