RecruitingPhase 1

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

Phase 1 Clinical Trial of Avasopasem in Patients With Metastatic Hormone Receptor Positive Breast Cancer With Progression on a CDK 4/6 Inhibitor and Hormonal Therapy (CTMS# 24-0096)

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

  • Procedures mentioned: CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Each treatment cycle will be 28 days and tumor assessment by imaging with CT scans of the chest, abdomen and pelvis will be performed every two cycles."
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 avasopasem to a CDK 4/6 inhibitor and hormone therapy is safe and helps treatment work better. It is for adults with hormone-sensitive, HER2-negative breast cancer that has spread and gotten worse on these treatments.

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.

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

Eligibility

Who can join

  • Be age 18 or older, able to understand the study, and willing to sign a consent form.
  • Have breast cancer confirmed by a tissue test that has spread to other parts of the body. Tests must show hormone receptors in at least 10% of cancer cells and a HER2-negative result.
  • Have cancer that got worse while taking ribociclib or abemaciclib with anastrozole, letrozole, exemestane, or fulvestrant. If you switched from palbociclib, the switch must have been for side effects, not cancer growth, with at least 3 months stable on the new drug.
  • Men and women who have not fully gone through menopause must take an LHRH agonist, a drug that lowers sex hormone levels.
  • Have cancer that can be measured and enough samples for study testing. If cancer in the brain was treated, a scan at least 6 weeks after treatment must show no growth.
  • Be fully active or able to do light work, and expected to live at least 12 weeks. Blood counts and organ tests must meet study limits. People with heart disease or symptoms must also meet the study's heart function limit.
  • If able to become pregnant, have a negative blood pregnancy test within 7 days before signing up. Use birth control or avoid sex before and during the study and for 3 weeks after treatment ends.

Who can't join

  • Have had treatment that travels through the body for cancer that has spread, other than hormone therapy with a CDK 4/6 inhibitor. Radiation to relieve symptoms and bone-protecting drugs are allowed.
  • Currently take palbociclib or tamoxifen.
  • Have new or growing cancer in the brain that has not been treated, or cancer in the lining around the brain and spinal cord.
  • Use nitrate medicines and PDE5 inhibitors at the same time.
  • Take drugs that strongly change how the liver enzyme CYP3A4 works and cannot stop them 2 weeks before joining.
  • Have another illness or condition that could make the study unsafe or affect participation or results. HIV or infectious hepatitis must be well controlled, with stable treatment when needed.
  • Be pregnant or breastfeeding.
  • Have had another invasive cancer in the past 2 years, except for local basal cell or squamous cell skin cancer.

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

Official eligibility criteria

Inclusion Criteria: * 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. NOTE: A FOCBP is any woman who meets the following criteria: * 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 Criteria: * 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.

Study sites (1)

TX