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Lerociclib + Hormone Therapy for Breast Cancer
Study Summary
This trial is testing a new cancer drug, lerociclib, to see if it is safe and effective when used with standard endocrine therapy to treat HR+/HER2- MBC in both newly diagnosed and treatment-resistant patients. The trial population will consist of both men and women.
- Breast Cancer
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have a serious lung condition or breathing problems.You have already been treated with chemotherapy or a CDK4/6 inhibitor, except for treatments before or after surgery.Your bone marrow and organs are working well.You have already been treated with fulvestrant before.You have a lot of disease in your organs that makes you unsuitable for endocrine therapy, according to the doctor in charge of the study.You have cancer that has spread to the lining of your abdomen.You have inflammatory breast cancer when you are screened.You have a brain tumor that is not getting worse and you are not taking certain medications for it.You have serious heart problems that are not under control.You have a history of a heart condition that causes abnormal heartbeats.You are taking estrogen pills or other estrogen treatments.You are taking certain medications that can affect how the study drug works in your body.You take medications that are mainly processed by the CYP3A4/5 enzyme and have a small range for safe and effective use.A heart test done in the past year showed that your heart is not pumping blood effectively, or you have a history of heart failure with reduced ejection fraction.You have a confirmed SARS-CoV-2 infection or a high fever at the time of screening.You have been diagnosed with estrogen-receptor positive and/or progesterone receptor positive breast cancer, and your cancer does not have the HER2 gene.You have breast cancer that has spread and cannot be cured with surgery or radiation.You are in good enough health to perform daily activities without any major problems.
- Group 1: Lerociclib + letrozole or fulvestrant
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Can you elaborate on other research that has been conducted with this medication?
"There are 266 different ongoing studies investigating this treatment, with 68 of them being in the third and final stage. Out of all the research locations for this study, 16549 of them are based in San Francisco, California."
Has this particular medication been federally sanctioned by the FDA?
"The safety of this novel treatment falls in the middle of our 1-3 scale at a 2. This is because, although there is some data supporting safety, there is currently no evidence that the intervention is effective."
Is this experiment accessible in many different city locations?
"So far, this experiment has taken place at Oregon Oncology Specialists in Salem, Oregon, Cancer Care Associates of York, Inc. in York, Pennsylvania, and Nebraska Cancer Specialists in Omaha, Nebraska. 5 other locations are also being used."
What indications does this therapy generally target?
"Progression, disease is most commonly treated with this treatment. However, this treatment can also be useful for treating other conditions such as tamoxifen, postmenopause, and carcinoma."
Are there any current openings for volunteers in this research project?
"The most recent information on clinicaltrials.gov suggests that this study is still looking for participants. This trial was first advertised on December 21st, 2021 and has had one update since then on October 19th, 2022."
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