Biology Guided Therapy for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new approach to treating advanced breast cancer that is hormone receptor positive and inoperable. Researchers will analyze tumor tissue from participants to create personalized reports suggesting the most effective treatments based on the tumor's unique biology. The trial seeks individuals whose cancer has worsened despite previous hormone treatments. Participants will collaborate with their doctors to consider Biology Guided Therapy Recommendations, which are customized treatment options. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, it does exclude those who have had certain treatments in the metastatic setting, so it's best to discuss your current medications with the trial team.
What prior data suggests that this biology guided therapy recommendations report is safe?
Research has shown that biology-guided therapy recommendations involve studying a patient's tumor tissue. This process helps identify which medications might be most effective and which ones the cancer might resist, based on the tumor's biology. However, specific safety information about these therapy recommendations remains limited.
As this is an early-stage trial, researchers are still evaluating the treatment's safety in humans. They closely monitor any side effects and how well participants tolerate the treatment. Although this does not yet provide complete safety information, it indicates that the therapy is still in the early testing phase. Prospective participants should discuss potential risks and benefits with their healthcare provider.12345Why are researchers excited about this trial?
Unlike traditional treatments for breast cancer that often follow a one-size-fits-all approach, Biology Guided Therapy is unique because it tailors treatment based on the specific biological makeup of a patient's tumor. Researchers are excited about this method because it provides personalized treatment recommendations by analyzing mutations such as PIK3CA, ESR1, HER2, and mTOR sensitivity or resistance. This customized approach has the potential to improve treatment effectiveness by directly targeting the unique characteristics of an individual's cancer, leading to more precise and potentially more effective care.
What evidence suggests that this biology guided therapy report is effective for advanced breast cancer?
Research has shown that biology-guided therapy could be a promising approach for treating advanced breast cancer. In this trial, tumor tissue from patients will be analyzed to generate a report suggesting the best treatments based on tumor biology. Studies have found that targeting specific DNA changes, such as PIK3CA, ESR1, or HER2, can help identify effective drugs for hormone receptor-positive breast cancer. For instance, about 25% of patients with a PIK3CA mutation responded well to a combination of the drugs fulvestrant and alpelisib. These personalized treatment suggestions can manage advanced cancer more effectively by focusing on the unique biology of each tumor.24678
Who Is on the Research Team?
Irene M Kang
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
This trial is for people with advanced, unresectable, or metastatic breast cancer that tests positive for hormone receptors. Participants must have cancer that cannot be removed by surgery or has spread to other parts of the body.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients undergo tumor tissue analysis and receive a biology guided therapy recommendations report. Physicians determine a treatment regimen based on the report.
Follow-up
Participants are monitored every 3 months until disease progression
What Are the Treatments Tested in This Trial?
Interventions
- Biology Guided Therapy Recommendations
Trial Overview
The study is testing whether using a personalized report—created from analyzing tumor samples and scans—can help doctors choose the best treatment options for each patient based on their specific cancer biology.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients have their tumor tissue analyzed. Their physician receives a report based on their tumor biology consisting of their predicted ongoing response to endocrine therapy, predicted ongoing response to endocrine therapy plus PIK3CA mutation or ESR1 mutation or HER2 mutation or mTOR sensitivity/resistance. The report includes treatment recommendations and the results of the specific tests completed on the tumor tissue. Physicians then determine a treatment regimen for the patient that may or may not include the treatment recommended in the report. Patients undergo blood sample collection and CT scan or MRI and/or bone scan and/or PET scan throughout the study. Patients may undergo tumor biopsy during screening and may optionally undergo at progression.
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
1.
ctv.veeva.com
ctv.veeva.com/study/biology-guided-therapy-recommendations-for-treatment-determination-of-hormone-receptor-positive-advaBiology Guided Therapy Recommendations for Treatment ...
The biology guided therapy recommendations report is developed from testing a patients tumor tissue when they have progression to see what medications may work ...
Breast Cancer: Molecular Pathogenesis, Targeted Therapy ...
It describes key biological processes that shape tumor heterogeneity and examines targeted therapies, including endocrine agents, HER2‐directed drugs, CDK4/6 ...
Genomically Guided Breast Radiation Therapy: A Review ...
Whole breast radiation therapy significantly reduces the rate of local recurrence after breast conserving therapy, which has translated to an improvement in ...
Biological Therapies for Treating Breast Cancer
For example, adhering to physical activity guidelines has been associated with reductions in mortality as high as 30% in patients with breast ...
New Directions in the Treatment of Breast Cancer: Bringing ...
New scientific advances have rapidly transformed the approach to breast cancer. In our next Grand Rounds, Hope Rugo, MD, professor of ...
6.
uspreventiveservicestaskforce.org
uspreventiveservicestaskforce.org/uspstf/recommendation/breast-cancer-screeningRecommendation: Breast Cancer: Screening
The Task Force recommends that all women get screened for breast cancer every other year, starting at age 40 and continuing through age 74, to reduce their ...
Biology Guided Therapy Recommendations for Treatment ...
The biology guided therapy recommendations report is developed from testing a patients tumor tissue when they have progression to see what ...
Endocrine Therapy for the Management and Risk ...
Endocrine therapy is an effective treatment for breast cancer. It is used in the adjuvant setting for hormone receptor positive (HR+) ...
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