Targeting Aurora A Kinase to Overcome Treatment Resistance in Advanced HR+/HER2+ Breast Cancer (NCT07706179) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Targeting Aurora A Kinase to Overcome Treatment Resistance in Advanced HR+/HER2+ Breast Cancer
United States10 participantsStarted 2026-08
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 patien…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial targets something called Aurora A Kinase to try to overcome treatment resistance in HR+/HER2+ breast cancer — can you explain what that means for my specific situation, and whether my cancer has shown signs of resistance that might make this approach worth exploring?
2Since this is a Phase 2 trial that isn't recruiting yet, what does that mean for how much is already known about the safety and effectiveness of this treatment combination, and should I pursue currently available standard options first while waiting for it to open?
3The trial measures success partly by looking at circulating tumor DNA, or ctDNA, in the blood — is that something you're already tracking in my case, and what would a decline in ctDNA actually tell us about how my cancer is responding?
4Because the trial is listed as 'not yet recruiting,' do you have a sense of when it might open, which centers might offer it, and whether there's any way to be notified or pre-screened when enrollment does begin?
5Are there other trials or approved therapies targeting treatment resistance in HR+/HER2+ metastatic breast cancer that might be worth comparing to this one, so we can think through whether this approach fits my overall treatment plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical benefit defined as partial tumor response (PR)
Timeframe: 12 weeks
2
Clinical benefit defined as complete tumor response (CR)
Timeframe: 12 weeks
3
Clinical benefit defined as decline in circulating tumor DNA (ctDNA)