Actively Recruiting
Phase 1 Clinical Trial of Avasopasem Added to CDK 4/6 Inhibitor and Hormonal Therapy in Patients With Metastatic Hormone Receptor Positive Breast Cancer
Led by The University of Texas Health Science Center at San Antonio · Updated on 2025-10-31
35
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and potential effectiveness of adding avasopasem to existing treatment with a CDK 4/6 inhibitor and hormonal therapy in patients with metastatic hormone receptor positive breast cancer who have experienced disease progression. This phase 1 non-randomized trial focuses on women with this specific type of breast cancer that has progressed despite first-line treatment. The study aims to understand if avasopasem can improve outcomes when combined with current therapies. Participants will receive avasopasem alongside their ongoing CDK 4/6 inhibitor (ribociclib or abemaciclib) and hormonal therapy (an aromatase inhibitor or fulvestrant). Treatment cycles last 28 days, and the study will assess the tumor response through CT scans of the chest, abdomen, and pelvis every two cycles. This trial does not include patients on palbociclib as their current CDK 4/6 inhibitor. The treatment phase is planned for up to four months. During the study, participants will undergo regular imaging to monitor tumor changes and assessments to track safety and tolerability of the combination treatment. Researchers will measure clinical benefits and monitor side effects throughout each 28-day cycle. Patients must meet specific health and organ function criteria and will be monitored closely for any adverse effects. Participation may last several months, with ongoing evaluations to understand treatment impact and safety.
CONDITIONS
Brief 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 HR+, HER2 negative metastatic breast cancer
- Estrogen receptor and/or progesterone receptor positivity of at least 10% by immunohistochemistry
- HER2 negative defined by IHC 0 or 1+, or 2+ with non-amplified gene by FISH
- Progression on ribociclib or abemaciclib plus hormonal therapy (aromatase inhibitor or fulvestrant) in metastatic setting
- Patients previously on palbociclib must have switched to ribociclib or abemaciclib for toxicity management and be stable for at least 3 months
- Both men and pre/perimenopausal women must be on ovarian suppression with LHRH agonist
- Measurable disease based on RECIST 1.1 criteria
- Females of child-bearing potential must use adequate contraception and have a negative pregnancy test within 7 days before registration
- Age 18 years or older at consent
- Estimated life expectancy of at least 12 weeks
- ECOG performance status 0 or 1
- Adequate organ and bone marrow function as defined by blood counts and liver/kidney tests
- Patients with treated brain metastases stable for at least 6 weeks
- Sufficient samples available for study requirements
- Cardiac function class 2B or better based on NYHA classification
- Ability and willingness to sign informed consent
You will not qualify if you...
- Use of systemic therapy in metastatic setting other than hormonal therapy with CDK 4/6 inhibitor
- Untreated or progressive brain metastases or leptomeningeal disease
- Use of nitrates and PDE5 inhibitors
- Use of potent CYP3A4 inhibitors or inducers not discontinued 2 weeks prior to enrollment
- Any condition interfering with study compliance or safety as judged by investigator
- Current pregnancy 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Repeated 28-day cycles up to 4 months
Participants receive Avasopasem in addition to their ongoing CDK 4/6 inhibitor and hormonal therapy to assess safety and efficacy.
Tumor assessments with CT scans every 8 weeks (every two cycles)
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
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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