RecruitingPhase 2

Artificial Intelligence and Machine Learning to Guide CDK4/6 Inhibitor Rechallenge in Breast Cancer.

Artificial Intelligence and Machine Learning-Enhanced Biomarker-dRiven CDK4/6 Inhibitor Rechallenge in HR+ HER2- Advanced Breast Tumors.

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
Mentioned in the study description

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: Questionnaires, Pills, Biopsies

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
  • "Visit the clinic once every month for checkups, tests, and questionnaires."
  • "Keep a diary of the pills they take at home."
  • "Next-generation sequencing of the tumor will be performed using biopsies obtained after the first CDK4/6 inhibitor treatment and within six months of study enrollment."
Compensation
Mentioned in the study description
  • 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 artificial intelligence (AI) can find people whose advanced breast cancer may respond to a second CDK4/6 drug, which blocks cancer cell growth. It is for people with HR-positive, HER2-negative breast cancer that got worse after a first CDK4/6 drug. Researchers will compare a second CDK4/6 drug plus fulvestrant, a hormone treatment, with treatment chosen by the doctor to see which works better and how safe it is.

The goal of this clinical trial is to learn if an artificial intelligence model will be able to select patients with advanced breast cancer who may respond to a second cyclin-dependent kinase 4/6 (CDK4/6) inhibitor after they have progressed on the first CDK4/6 inhibitor. Patients for this study need to have hormone receptor positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer. The main questions the study aims to answer are: If the artificial intelligence model says that a patient's tumor should respond to the second CDK4/6 inhibitor, and that patient receives the second CDK4/6 inhibitor together with fulvestrant (an endocrine therapy also called Faslodex), will it take longer for the tumor to get worse than if the patient receives another type of therapy? Will the tumor respond better? Will the therapy be safe? Researchers will compare the combination of a second CDK4/6 inhibitor plus fulvestrant to the therapy chosen by the physician. Participants will: Take the assigned therapy based on the way the therapy is usually prescribed. Visit the clinic once every month for checkups, tests, and questionnaires. Keep a diary of the pills they take at home.

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

Eligibility

Who can join

  • Be older than 18, able to care for yourself, and out of bed or a chair for at least half of waking hours. You must understand and sign the consent form and agree to study visits and tests.
  • Have breast cancer confirmed by a tissue test that has spread or cannot be removed by surgery. It must be HR-positive (uses hormones to grow) and HER2-negative (does not have high levels of the HER2 protein).
  • Have cancer that is still sensitive to hormone treatment: it did not return during the first 2 years of hormone treatment after surgery or worsen within the first 6 months of initial hormone treatment for cancer that had spread.
  • Have cancer that worsened after at least 6 months of one prior CDK4/6 treatment for cancer that had spread, or within 6 months of finishing CDK4/6 treatment plus hormone treatment after surgery. Another CDK4/6 treatment must be an option.
  • Have had no more than one prior course of chemotherapy or an antibody-drug treatment for cancer that had spread. The study AI must predict that your cancer may respond to palbociclib, a CDK4/6 drug.
  • Have suitable tumor tissue from a site other than bone, collected after CDK4/6 treatment and within 6 months before joining. Gene testing results must be available, or testing must be possible; an older sample requires a repeat biopsy.
  • Have cancer that doctors can track and blood cell counts that meet the study's limits.
  • If you or your partner could become pregnant, follow the birth control rules during treatment and for 3 months afterward. Women must use non-hormonal birth control starting at least 1 month before treatment.

Who can't join

  • Be expected to live less than 6 months.
  • Have a physical or mental health condition that makes treatment unsafe or prevents you from following study procedures.
  • Have used another study drug within 3 weeks before joining that is known to affect how the selected treatment works in the body.
  • Have an uncontrolled illness, such as an active infection, heart failure, unstable chest pain, an abnormal heartbeat, lung disease needing oxygen all the time, severe liver disease, or kidney failure needing dialysis.
  • Be unable to get the needed study drugs as part of usual care: abemaciclib, palbociclib, ribociclib, or fulvestrant.
  • Be pregnant or breastfeeding.

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

Official eligibility criteria

Inclusion Criteria: 1. Age \>18 years 2. Eastern Cooperative Oncology Group performance status 0-2 3. Ability to understand and sign the informed consent document 4. Stated willingness to comply with all study procedures and availability for the duration of the study 5. Advanced breast cancer (defined as unresectable or metastatic) histologically confirmed hormone receptor positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer per American Society of Clinical Oncology/College of American Pathologists (CAP) guidelines. 6. Endocrine-sensitive disease per the 7th International Consensus Conference on Advanced Breast Cancer (ABC7) 2023 guideline: no relapse during the first 2 years of adjuvant endocrine therapy or progression within the first 6 months of first-line endocrine therapy in the metastatic setting. 7. Progression of disease, radiographically per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria or clinically per physician assessment, after a minimum of 6 months of 1 prior line of any CDK4/6 inhibitor therapy plus or minus endocrine therapy in the metastatic setting, or within 6 months of completing adjuvant CDK4/6 inhibitor with endocrine therapy. 8. An additional line of therapy with CDK4/6i is possible and available. 9. Zero to 1 prior line of chemotherapy or antibody-drug conjugates in the metastatic setting. 10. Available next-generation sequencing panel testing results - or possibility to perform next-generation sequencing panel testing - on tumor tissue biopsy collected within 6 months of enrollment but after CDK4/6 inhibitor exposure. Note that If biopsy was performed more than 6 months before enrollment, the patient is not eligible to participate, unless the biopsy is repeated during the prescreening phase. Adequate tissue/testing will be one of these: 1. safe non-osseous tumor site for fresh tissue biopsy and subsequent tissue-based next-generation sequencing testing by any Clinical Laboratory Improvement-certified laboratory. Biopsy and next-generation sequencing testing will be performed as standard of care evaluation. 2. archival non-osseous tumor tissue adequate for standard of care next-generation sequencing testing by any Clinical Laboratory Improvement Amendments-certified labs. 3. prior tissue-based next-generation sequencing testing on tissue that was collected and performed within 6 months of study enrollment. 11. Palbociclib sensitive disease as determined by the palbo-VNN model. 12. Participants can have non-measurable but evaluable disease or measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria 13. Participants must have organ and marrow function as defined below: 1. Leukocytes \> 3,000/microliter 2. Hemoglobin \> 8 g/deciliter 3. Absolute neutrophil count \> 1,200/microliter 4. Platelets \> 75,000/microliter 14. For participants of reproductive potential: 1. Females: use of highly effective contraception for at least 1 month before initiation of treatment with study medications (cycle 1 day 1) and agreement to use such a method during study participation and until 3 months after the end of treatment visit. Only non-hormonal contraception (eg., copper intrauterine device, barrier, condoms with spermicidal, sponge with spermicidal, or diaphragm with spermicidal), is allowed. 2. Males: use of condoms or other methods to ensure effective contraception with a partner during study participation and until 3 months after the end of treatment visit. For partners, use of hormonal contraception is allowed. 15. Palliative radiotherapy is allowed. 16. Participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate locoregional central nervous system-specific treatment is not required and is unlikely to be required during the first cycle of therapy. 17. Human immunodeficiency virus-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible. 18. For participants with evidence of chronic hepatitis B virus infection, the viral load must be undetectable on suppressive therapy, if indicated. 19. Participants with a history of hepatitis C virus infection must have been treated and cured. For participants with hepatitis C virus infection who are currently on treatment, they are eligible if they have an undetectable viral load. 20. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible. Exclusion Criteria: 1. Life expectancy less than 6 months. 2. Any medical or psychiatric condition that would prevent the safe use of a CDK4/6 inhibitor or fulvestrant or treatment of physician's choice or the ability to participate in study procedures. 3. Participants who are receiving any other investigational agents within 3 weeks of study enrollment only if there is a known pharmacokinetic interaction with the selected drug. No washout period is otherwise required. 4. Uncontrolled intercurrent illness including ongoing or active infection, congestive heart failure, unstable angina pectoris or cardiac arrhythmia, lung disease requiring continuous oxygen supplementation, decompensated cirrhosis, end-stage kidney disease on dialysis, or psychiatric illness that limits the ability to participate in the study. 5. Unable to have access to abemaciclib, palbociclib, ribociclib, or fulvestrant as a standard of care treatment. 6. Pregnancy or lactation.

Study sites (1)

CA