RGT-419B + Hormonal Therapy for Breast Cancer
Trial Summary
The trial does not specify if you need to stop your current medications, but it mentions that major treatments like chemotherapy or radiation should not have been received within 14-28 days before starting the trial. It's best to discuss your current medications with the trial team.
The research highlights that combining hormonal therapy with other agents, like CDK4/6 inhibitors, has improved survival rates in breast cancer patients. This suggests that combining RGT-419B with hormonal therapy might also enhance treatment effectiveness by potentially overcoming resistance to endocrine therapy.
12345The safety of targeted therapies like CDK4/6 inhibitors, which are often combined with hormone therapy for breast cancer, is generally manageable but can include side effects like neutropenia (low white blood cell count) and stomatitis (mouth sores). These side effects require careful management, often involving dose adjustments or additional treatments.
678910RGT-419B + Hormonal Therapy is unique because it combines a novel drug, RGT-419B, with hormonal therapy, potentially offering a new mechanism of action or enhanced effectiveness compared to existing treatments like tamoxifen or aminoglutethimide alone. This combination may provide a more comprehensive approach by targeting different pathways involved in breast cancer progression.
1112131415Eligibility Criteria
This trial is for adults with HR+, HER2- advanced or metastatic breast cancer who've had no more than one prior chemotherapy in this setting and less than three lines of CDK4/6i therapy. Participants must have an ECOG Performance Status of 0 to 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive RGT-419B as monotherapy or in combination with Hormonal Therapy to evaluate safety, tolerability, and pharmacokinetics
Follow-up
Participants are monitored for safety, tolerability, and efficacy through study completion