Actively Recruiting
Clinical Trial of Avasopasem in Patients With Metastatic Hormone Receptor Positive Breast Cancer With Progression on a CDK 4/6 Inhibitor and Hormonal Therapy
Led by The University of Texas Health Science Center at San Antonio · Updated on 2025-10-31
35
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the safety of avasopasem in combination with CDK 4/6 inhibitor and hormonal therapy in women with metastatic hormone receptor positive breast cancer, and to see if the addition of avasopasem improves the effectiveness of a CDK 4/6 inhibitor and hormonal therapy.
CONDITIONS
Official Title
Clinical Trial of Avasopasem in Patients With Metastatic Hormone Receptor Positive Breast Cancer With Progression on a CDK 4/6 Inhibitor and Hormonal Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of hormone receptor positive, HER2 negative metastatic breast cancer
- Estrogen or progesterone receptor positivity defined as at least 10% tumor cell nuclei positive by immunohistochemistry
- HER2 negative defined by IHC 0 or 1+, or non-gene amplified if IHC 2+
- Progression on treatment with ribociclib or abemaciclib plus hormonal therapy
- Previous use of palbociclib allowed if stable on ribociclib or abemaciclib for at least three months due to toxicity management
- Hormonal therapy must be an aromatase inhibitor or fulvestrant; tamoxifen use excludes participation
- Men and pre/perimenopausal women must be on ovarian suppression with an LHRH agonist
- Measurable disease by RECIST 1.1 criteria
- Females of child-bearing potential must agree to use adequate contraception during and after study participation
- Age 18 years or older at consent
- Estimated life expectancy of at least 12 weeks
- ECOG performance status of 0 or 1
- Adequate organ and bone marrow function as defined
- Patients with treated brain metastases with no progression on imaging at least 6 weeks post-treatment
- Sufficient samples available for specimen requirements
- Cardiac function class 2B or better per NYHA classification
- Ability and willingness to provide informed consent
You will not qualify if you...
- Receipt of any systemic therapy in the metastatic setting other than hormonal therapy plus a CDK 4/6 inhibitor
- Untreated new or progressive brain metastases or leptomeningeal disease
- Use of concomitant nitrates and PDE5 inhibitors
- Use of potent CYP3A4 inhibitors or inducers that cannot be stopped two weeks before trial enrollment
- Any illness or condition interfering with study compliance or safety, including uncontrolled HIV or hepatitis
- Currently pregnant or breastfeeding
- History of another invasive malignancy within 2 years except local skin cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mays Cancer Center, UT Health San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
K
Kate Lathrop, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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