Endocrine Therapy for Breast and Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines whether the time of day influences the effectiveness of hormone treatments for individuals with metastatic breast or prostate cancer. It compares taking the treatment in the morning versus the evening to determine which timing improves quality of life, tolerance, and effectiveness. Individuals with hormone receptor-positive metastatic breast cancer or castrate-sensitive prostate cancer, who are beginning specific hormone treatments like ARPI (androgen receptor pathway inhibitor) or a CDK4/6 inhibitor, may qualify. Participants must commit to taking their medication at a specific time and completing questionnaires. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications. However, you must be planning to start specific cancer treatments as part of the study. It's best to discuss your current medications with the trial team.
What is the safety track record for these treatments?
In earlier studies, CDK4/6 inhibitors for breast cancer have proven safe. Research has found that combining these inhibitors with other treatments, like anti-HER2 therapies, helps control the disease and slows tumor growth in most patients. A review of studies also found that using CDK4/6 inhibitors with certain radiation therapies is safe for patients with metastatic cancer.
For prostate cancer, drugs that block the androgen receptor pathway (ARPI) have undergone extensive study. Research shows that ARPI, when combined with other treatments, significantly improves survival rates compared to standard hormone treatments alone. Studies have consistently shown that patients generally tolerate these treatments well.
Overall, both CDK4/6 inhibitors for breast cancer and ARPI for prostate cancer are generally well-tolerated, with manageable side effects, as reported in clinical trials. This suggests a positive outlook for their safety in ongoing and future studies.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments because they take a novel approach to managing breast and prostate cancers. Unlike standard treatments, which often focus on hormone suppression or chemotherapy, the CDK4/6 inhibitors for breast cancer and ARPI for prostate cancer target specific proteins involved in cancer cell growth. CDK4/6 inhibitors interfere with cancer cell division, potentially slowing down tumor progression more effectively. Meanwhile, ARPI targets androgen receptors in prostate cancer, which could offer a more tailored attack on cancer cells. This targeted strategy might lead to better outcomes with potentially fewer side effects compared to traditional therapies.
What evidence suggests that this trial's treatments could be effective for metastatic breast and prostate cancer?
Research shows that CDK4/6 inhibitors, which participants in the breast cancer cohort of this trial may receive, effectively treat advanced breast cancer. Studies have found that combining these drugs with hormone therapy can extend the period during which the cancer does not grow from 14.4 months to about 27 months. This allows patients longer periods without their cancer worsening.
For advanced prostate cancer, androgen receptor pathway inhibitors (ARPI), which participants in the prostate cancer cohort of this trial may receive, have demonstrated strong results. Initial treatments with ARPI have improved survival rates compared to other therapies. One study found that patients experienced significant drops in prostate-specific antigen levels, which correlated with longer survival and slower disease progression. This makes ARPI a promising option for those with advanced prostate cancer.23567Who Is on the Research Team?
Marie-France Savard, MD
Principal Investigator
The Ottawa Hospital
Ana-Alicia Beltran-Bless, MD
Principal Investigator
The Ottawa Hospital
Are You a Good Fit for This Trial?
This trial is for individuals with metastatic breast or prostate cancer. Participants will be assigned to take their endocrine therapy either in the morning or evening. The study aims to set up for a larger future trial by testing if the timing of medication affects quality of life, tolerability, and effectiveness.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive endocrine-based therapy either in the morning or evening based on random group assignment
Follow-up
Participants are monitored for safety, quality of life, and efficacy outcomes
Long-term follow-up
Participants' overall survival and time to second-line systemic treatment are monitored
What Are the Treatments Tested in This Trial?
Interventions
- ARPI
- CDK4/6 Inhibitor
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ottawa Hospital Research Institute
Lead Sponsor