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Avasopasem for Metastatic Hormone Receptor Positive Breast Cancer

This study is looking at a drug called avasopasem, given along with your current CDK 4/6 inhibitor and hormonal therapy, for metastatic hormone receptor positive (HR+) breast cancer. This is for people whose cancer has progressed after their first treatment with a CDK 4/6 inhibitor and hormonal therapy. The main goal is to see how safe avasopasem is and how well people tolerate it. Researchers also want to see if adding avasopasem makes the current treatment more effective. To join, you need to have HR+ and HER2 negative breast cancer, meaning your tumor cells show specific markers. This study plans to enroll 35 participants.

Study design
This is a Phase 1 non-randomized study involving about 35 participants. It is designed to evaluate the safety and effectiveness of avasopasem.
What's involved
You would receive avasopasem along with your current medications. Treatment cycles are 28 days, and tumor assessments with CT scans will happen every two cycles.
Compensation
Not stated in the trial record.
Follow-up
Safety and tolerability will be measured from Day 1 through Day 28, for up to 4 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07137871

Clinical Trial of Avasopasem in Patients With Metastatic Hormone Receptor Positive Breast Cancer With Progression on a CDK 4/6 Inhibitor and Hormonal Therapy

Recruiting
PHASE1Ages 18+InterventionalTreatment
The University of Texas Health Science Center at San Antonio
~35 participants
Updated 2025-10-31 on ClinicalTrials.gov
What's tested:Avasopasem

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine Safety and Tolerability of Treatment
Measured over Day 1 through Day 28 (each cycle is 28 days, up to 4 months

Conditions

Breast Cancer Metastatic

Explore related trials

Breast CarcinomaPGR Gene

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Kate Lathrop, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center at San Antonio

Who to contact

Kate Lathrop, MD
[email protected]
210-450-1000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Histologically confirmed diagnosis of HR+, HER2 negative metastatic breast cancer.
Estrogen receptor (ER) and/or progesterone receptor (PR) expression positivity is defined as at least 10% of tumor cells nuclei positive by immunohistochemistry in the sample on testing.
HER2 negative: defined as IHC staining of 0 or 1+. If HER2 overexpression is equivocal by IHC, defined as 2+, the tumor must be non-gene amplified by FISH (ratio \<2 and HER2 copy number \<4).
Progression on treatment with a CDK 4/6 inhibitor and hormonal therapy in the metastatic setting
The CDK 4/6 inhibitor must be ribociclib or abemaciclib. Patients on palbociclib are not eligible.
Patient may have been on palbociclib previously but must have been stable on ribociclib or abemaciclib for at least three months prior to enrolling. In this case, the switch from palbociclib to either ribociclib or abemaciclib must have been of toxicity management and not progression of disease.
Hormonal therapy is defined as an aromatase inhibitor (anastrozole, letrozole, exemestane) or fulvestrant.
Patients on tamoxifen are not eligible.
Both men and pre/perimenopausal women must be on ovarian suppression with a luteinizing hormone-releasing hormone (LHRH) agonist.
Patients must have measurable disease based on RECIST 1.1 criteria.
Females of child-bearing potential (FOCBP) who engage in intercourse must agree to use adequate contraception (e.g., hormonal or an intrauterine device \[IUD\] or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 3 weeks following completion of therapy.
Has not undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy
Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months)
FOCBP must have a negative serum pregnancy test within 7 days prior to registration.
Patients must be ≥ 18 years of age at the time of signing consent.
Patients must have an estimated life expectancy of at least 12 weeks.
Patients must exhibit an ECOG performance status of 0 or 1.
Patients must have adequate organ and bone marrow function as defined below:
Leukocytes (WBC) ≥ 3,000/mcL
Absolute neutrophil count (ANC) ≥ 1000/mcL
Hemoglobin (Hgb) ≥ 7 g/dL
Platelets (PLT) ≥ 100,000/mcL
Total bilirubin \< 1.5 x Institutional upper limit of normal (ULN); ≤ 3.0 x ULN for patients with Gilbert's syndrome
AST (SGOT)/ALT (SGPT) \< 3 x institutional ULN, or \< 5 x ULN if liver metastasis present
Creatinine \< 1.5 Institutional ULN
Patients with treated brain metastases are eligible if follow-up brain imaging at least 6 weeks after central nervous system (CNS)-directed therapy shows no evidence of progression.
Patients must have sufficient samples available to meet Menarini Silicon Biosystems (MSB) specimen requirements.
Patients with known history or current symptoms of cardiac disease, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
Patients must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion

Patients who have any systemic therapy in the metastatic setting except hormonal therapy in combination with a CDK 4/6 inhibitor. Previously palliative targeted radiation therapy is allowed. Bone targeting agents such as bisphosphonates and rank ligand inhibitors for metastatic breast cancer to the bone is also allowed prior and during this trial.
Patients with untreated new or progressive brain metastases or leptomeningeal disease
Use of concomitant nitrates and PDE5 inhibitors.
Use of potent CYP3A4 inhibitors or inducers and not able to discontinue two weeks prior to enrolling onto the trial.
Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints. Note: Patients with HIV or infectious hepatitis must exhibit well controlled disease with stable treatment regimen (where applicable) that in the opinion of the treating physician should not preclude them from participating in the study.
Patients who are currently pregnant or breast feeding.
Patients with a history of another invasive malignancy within 2 years of registration with the exception of local squamous cell or basal cell carcinoma of the skin.

What this trial measures

  • Determine Safety and Tolerability of TreatmentDay 1 through Day 28 (each cycle is 28 days, up to 4 months

    Determine the safety and tolerability of Avasopasem in combination with a CDK 4/6 inhibitor and hormonal therapy. Each cycle of treatment will be 28 days. Toxicity will be assessed starting on the first day of each 28-day treatment cycle, using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, and the incidence, nature, and severity of adverse events will be determined.All women who receive at least one dose of Avasopasem will be considered as evaluable for any toxicity and safety endpoints, as well as disease response. Patient reported outcome (PRO's) for adverse events (AE) will also be reported on day one of each cycle.