Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer
A Phase II Trial to Evaluate Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer
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, PET scans, X-rays, Blood draws
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
- "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."
- "FFNP PET imaging is a form of x-ray that uses FFNP as an imaging agent that may provide more precise information about the location of tumors that "light up" with FFNP than a PET scan alone can provide."
- "Patients also receive FDG IV and undergo PET/CT imaging at baseline, with additional diagnostic imaging for tumor assessment every 3 cycles, and undergo blood sample collection throughout the study."
- 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 FFNP PET/CT scans can predict how breast cancer will respond to abemaciclib plus hormone therapy. It is for adults with hormone-sensitive, HER2-negative breast cancer that has spread or cannot be removed by surgery.
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. Abemaciclib blocks certain proteins, which may help keep tumor cells from growing. Endocrine therapy adds, blocks, or removes hormones that can cause cancer to grow. FFNP PET imaging is a form of x-ray that uses FFNP as an imaging agent that may provide more precise information about the location of tumors that "light up" with FFNP than a PET scan alone can provide.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older, with breast cancer that has spread or is advanced and cannot be removed by surgery.
- Cancer is ER-positive (can grow with estrogen) and HER2-negative, and hormone therapy is an option. Special rules may apply to bone biopsy results.
- At least one cancer site outside the liver must meet the study’s scan rules and be at least 1.5 cm across.
- If you have not gone through menopause, you must take hormone-blocking treatment called a GnRH agonist for at least 6 weeks before the scan.
- Prior hormone treatments are allowed. No more than one course of chemotherapy for cancer that has spread is allowed. Required treatment breaks and recovery rules apply.
- Able to care for yourself and be out of bed or a chair for at least half the day. Blood counts and liver and kidney tests must meet study limits.
- Use required birth control during treatment and for at least 30 days afterward. If you could become pregnant, you need a negative pregnancy test within 14 days before joining.
- You or your legal representative must sign a consent form. You must allow access to stored tumor samples for testing genetic information in tumor tissue and blood.
Who can't join
- Past abemaciclib for cancer that has spread, or finishing abemaciclib given after surgery less than 2 years ago.
- Cancer that has spread only to the liver.
- Another past cancer, unless all treatment ended at least 2 years ago and there is no sign of that cancer.
- Currently taking another experimental treatment.
- Cancer in the brain that is untreated or not stable. Treated, stable brain cancer may be allowed.
- Past allergic reactions to substances similar to FFNP, abemaciclib, or other study drugs.
- An uncontrolled illness, such as an active infection or certain heart problems, or being pregnant or breastfeeding.
- HIV with a CD4 immune cell count below 350, or an AIDS-related infection within the past 12 months.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion 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 Oncology/College of American Pathologists (ASCO CAP) Guidelines: ER+: \>= 1% of tumor cell nuclei to be immunoreactive. HER2-negative: HER2 of 0, 1+ by immunohistochemistry (IHC) or negative by fluorescence in situ hybridization (FISH). * 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 is a candidate for further endocrine therapy (ET) based treatment. * 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 but must be 1.5 cm in longest dimension on functional imaging (fluorodeoxyglucose \[FDG\]-PET/computed tomography \[CT\] preferred). * 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 cytotoxic chemotherapy in the metastatic setting is allowed. Washout from prior systemic anti-cancer therapy of at least 2 weeks from chemotherapy or radiation, 2 weeks or 5 half lives (whichever is longer) from oral selective estrogen receptor degrader (SERD), 8 weeks from oral selective estrogen receptor modulator (SERM), and 16 weeks from intramuscular SERD (Fulvestrant) is required. Recovery of adverse events from the last therapy to grade 1 except alopecia. Patients may continue luteinizing hormone-releasing hormone (LHRH) agonist to remain post-menopausal without a need for washout * 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 subjects with documented metastatic disease to the liver * 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 Exclusion Criteria: * 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 radiographically stable at study entry, are eligible * 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 contraceptive methods throughout study treatment and for at least 30 days after the last dose of study medications * 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 within the 12 months prior to registration. Concurrent treatment with effective antiretroviral therapy (ART) according to Department of Health and Human Services (DHHS) treatment guidelines is recommended
Study sites (3)
MO
- Siteman Cancer Center at Washington University · St Louis, MO 63110Farrokh Dehdashti · Study contact · 314-362-2809 · dehdashtif@wustl.eduFarrokh Dehdashti · Principal investigatorMore trials in St Louis
NC
- University of North Carolina · Chapel Hill, NC 27599Jorge Oldan · Principal investigatorMore trials in Chapel Hill
WA
- Fred Hutch/University of Washington Cancer Consortium · Seattle, WA 98109Hannah Linden · Study contact · 206-606-2053 · hmlinden@uw.eduHannah Linden · Principal investigatorMore trials in Seattle