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Targeting Aurora A Kinase to Overcome Treatment Resistance in Advanced HR+/HER2+ Breast Cancer

ConditionsHR+/HER2+ Breast CancerMetastatic Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Alisertib

    Drug

    Alisertib 40mg on days 1-7 of 21-day cycles for 4 cycles

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Alisertib plus standard of careExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Clinical benefit defined as partial tumor response (PR)

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.

Time frame
12 weeks
2

Clinical benefit defined as complete tumor response (CR)

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. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm

Time frame
12 weeks
3

Clinical benefit defined as decline in circulating tumor DNA (ctDNA)

Clinical benefit is defined as a decline in ctDNA by \>50%.

Time frame
12 weeks

Secondary outcomes

1

Evaluate safety of adding alisertib to usual care by assessing adverse events

To assess safety, adverse events related to alisertib will be assessed. They will be assessed using CTCAE v6.0.

Time frame
12 weeks
2

BRD8 signature expression

The 3-gene BRD8 signature (BRD8/AFF3/RBM24) will be evaluated as a predictive biomarker for response to alisertib combination therapy.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: