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New treatment option for Anatomic Stage III Breast Cancer AJCC v8
Official title Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer
ClinicalTrials.gov ID: NCT06179303
What this study is testing
What is Abemaciclib?
Abemaciclib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for anatomic stage iii breast cancer ajcc v8.
Also referred to as LY-2835219, LY2835219.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial tests the accuracy of functional imaging (FFNP)-positron emission tomography (PET)/computed tomography (CT) to predict response to abemaciclib plus endocrine therapy. Abemaciclib is a drug used to treat certain types of hormone receptor positive (HR+), HER2 negative breast cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Men or women with metastatic or locally advanced unresectable breast cancer
- Histologically confirmed ER+ / HER2-negative, breast cancer who is a candidate for endocrine therapy with pathology from the primary tumor or...
- In the case of bone biopsy which could yield false negative ER or PR status in patients with historically HR+ disease, a patient may be eligible if...
- Note that baseline PR status by IHC does not influence results of deltaFFNP-PET imaging.
- If premenopausal, the patient has to be treated with GnRH agonist for at least 6 weeks prior to FFNP-PET.
You likely can't join if
- Prior abemaciclib in the metastatic setting or within 2 years of completion of adjuvant abemaciclib
- Hepatic-only metastatic disease
- A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the...
- Currently receiving any other investigational agents
- Untreated/unstable brain metastases. Patients with treated/stable brain metastases, defines as patients who have received prior therapy for their...
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to FFNP, abemaciclib, or other agents used in the...
See the full eligibility criteria
- Men or women with metastatic or locally advanced unresectable breast cancer
- Histologically confirmed ER+ / HER2-negative, breast cancer who is a candidate for endocrine therapy with pathology from the primary tumor or metastatic/recurrent site. Based on American Society of Clinical...
- In the case of bone biopsy which could yield false negative ER or PR status in patients with historically HR+ disease, a patient may be eligible if the treating physician and the study chair both agree that the patient...
- Note that baseline PR status by IHC does not influence results of deltaFFNP-PET imaging.
- If premenopausal, the patient has to be treated with GnRH agonist for at least 6 weeks prior to FFNP-PET.
- Disease must be present in at least one non-liver site and measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and be 1.5 cm or greater in longest dimension OR disease can be non-measurable...
- No limits to prior lines of endocrine therapy in the metastatic setting including synergistic targeted therapy such as CDK4/6 inhibitors (other than Abemaciclib), PI3K inhibitor, mTOR inhibitor, etc. One line of prior...
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
- At least 18 years of age
- Absolute neutrophil count \>= 1,500/uL
- Platelets \>= 100,000/uL
- Hemoglobin \>= 9g/dL
- Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN).
- In case of known Gilbert's syndrome, \< 2 x ULN is allowed
- Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT) /alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) =\< 2.5x institutional ULN, or =\< 5 x ULN for people with...
- eGFR (estimated glomerular filtration rate) ≥ 30 mL/min
- Women of childbearing potential must agree to use adequate contraception (barrier method of birth control, abstinence) prior to study entry and for the duration of study participation
- Ability to understand and willingness to sign an institutional review board (IRB)-approved written informed consent document (or that of legally authorizes representative, if applicable)
- Consent to access archival tumor specimens for clinical sequencing data of tumor tissue and blood
- Prior abemaciclib in the metastatic setting or within 2 years of completion of adjuvant abemaciclib
- Hepatic-only metastatic disease
- A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease
- Currently receiving any other investigational agents
- Untreated/unstable brain metastases. Patients with treated/stable brain metastases, defines as patients who have received prior therapy for their brain metastases and whose central nervous system (CNS) disease is...
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to FFNP, abemaciclib, or other agents used in the study
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
- Pregnant and/or breastfeeding women of childbearing potential must have a negative pregnancy test within 14 days of study entry. Male participants and female participants of childbearing potential must utilize adequate...
- Patients with human immunodeficiency virus (HIV) are eligible unless their CD4+ T-cell counts are \< 350 cells/mcL or they have a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection...
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.