RightFit
Not yet recruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding alisertib to usual care helps treat HR+/HER2+ breast cancer that has spread to other parts of the body. This cancer has hormone receptors and high levels of a protein called HER2. Researchers will study whether alisertib blocks signals between them and whether gene markers help predict how well it works.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 18 and able to do at least some daily activities and self-care.
  • Have breast cancer that has spread to other parts of the body and tests positive for hormone receptors and HER2.
  • Have finished at least 4 cycles of chemotherapy with trastuzumab and pertuzumab, or fam-trastuzumab deruxtecan, without the cancer getting worse.
  • Be taking or planning to start hormone therapy with trastuzumab and pertuzumab, given separately or as PHESGO.
  • Have organs working well enough, based on lab tests within 28 days before signing up.
  • Have a heart pumping measurement of at least 50% on a heart scan within 6 weeks before study treatment.
  • Have cancer that can be measured, or cancer that can be checked with detectable tumor DNA in the blood.
  • Be willing to get shots that help prevent low white blood cell counts. Some people may skip these shots, but they are required if counts become very low or stay low.

Who can't join

  • Have an active infection that needs treatment acting throughout the body.
  • Have another past or current cancer that could affect how researchers judge this treatment’s safety or how well it works.
  • Have used an experimental drug too recently: within 14 days before signing up, or within the time it takes half the drug to leave the body five times, whichever is longer.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

WI