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New treatment option for Breast Cancer
Official title Artificial Intelligence and Machine Learning to Guide CDK4/6 Inhibitor Rechallenge in Breast Cancer.
ClinicalTrials.gov ID: NCT07227233
What this study is testing
What is A CDK4/6 inhibitor different from the first that the participant had received, plus fulvestrant.?
A CDK4/6 inhibitor different from the first that the participant had received, plus fulvestrant. is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for breast cancer.
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
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Age \>18 years
- Eastern Cooperative Oncology Group performance status 0-2
- Ability to understand and sign the informed consent document
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Advanced breast cancer (defined as unresectable or metastatic) histologically confirmed hormone receptor positive (HR+) human epidermal growth factor...
You likely can't join if
- Life expectancy less than 6 months.
- 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...
- Participants who are receiving any other investigational agents within 3 weeks of study enrollment only if there is a known pharmacokinetic...
- Uncontrolled intercurrent illness including ongoing or active infection, congestive heart failure, unstable angina pectoris or cardiac arrhythmia...
- Unable to have access to abemaciclib, palbociclib, ribociclib, or fulvestrant as a standard of care treatment.
- Pregnancy or lactation.
See the full eligibility criteria
- Age \>18 years
- Eastern Cooperative Oncology Group performance status 0-2
- Ability to understand and sign the informed consent document
- Stated willingness to comply with all study procedures and availability for the duration of the study
- 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...
- 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...
- 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...
- An additional line of therapy with CDK4/6i is possible and available.
- Zero to 1 prior line of chemotherapy or antibody-drug conjugates in the metastatic setting.
- 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...
- 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...
- archival non-osseous tumor tissue adequate for standard of care next-generation sequencing testing by any Clinical Laboratory Improvement Amendments-certified labs.
- prior tissue-based next-generation sequencing testing on tissue that was collected and performed within 6 months of study enrollment.
- Palbociclib sensitive disease as determined by the palbo-VNN model.
- Participants can have non-measurable but evaluable disease or measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria
- Participants must have organ and marrow function as defined below:
- Leukocytes \> 3,000/microliter
- Hemoglobin \> 8 g/deciliter
- Absolute neutrophil count \> 1,200/microliter
- Platelets \> 75,000/microliter
- For participants of reproductive potential:
- 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...
- 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...
- Palliative radiotherapy is allowed.
- 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...
- Human immunodeficiency virus-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible.
- For participants with evidence of chronic hepatitis B virus infection, the viral load must be undetectable on suppressive therapy, if indicated.
- 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...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible.
- Life expectancy less than 6 months.
- 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.
- 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.
- Uncontrolled intercurrent illness including ongoing or active infection, congestive heart failure, unstable angina pectoris or cardiac arrhythmia, lung disease requiring continuous oxygen supplementation, decompensated...
- Unable to have access to abemaciclib, palbociclib, ribociclib, or fulvestrant as a standard of care treatment.
- Pregnancy or lactation.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 La Jolla, California, United States. Enter your location above to see the nearest site and check your eligibility.
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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.