Ribociclib + Bicalutamide for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the combination of ribociclib and bicalutamide in patients with advanced AR+ triple-negative breast cancer. The drugs aim to stop cancer growth by blocking hormones and proteins that the cancer cells need to multiply.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you must stop all current medications. However, you must stop taking any strong inducers or inhibitors of CYP3A4/5, systemic corticosteroids, and herbal supplements like St. John's Wort at least 7-14 days before starting the study drugs. Also, you cannot take medications that prolong the QT interval or warfarin. Please consult with the trial team for specific guidance on your medications.
What safety data exists for Ribociclib + Bicalutamide in breast cancer treatment?
The provided research primarily discusses the safety and tolerability of Bicalutamide (Casodex) in the context of prostate cancer, not breast cancer. Bicalutamide is associated with side effects such as gynecomastia and breast pain, which have been significant enough to cause withdrawal from trials. Tamoxifen and radiotherapy have been explored to manage these side effects. However, there is no specific safety data for the combination of Ribociclib and Bicalutamide in breast cancer treatment in the provided research.12345
Is the drug Ribociclib, used with Bicalutamide, a promising treatment for breast cancer?
What data supports the idea that Ribociclib + Bicalutamide for Breast Cancer is an effective treatment?
The available research shows that Ribociclib, when combined with other treatments like letrozole, significantly improves outcomes for patients with advanced breast cancer. For example, the MONALEESA trials demonstrated that Ribociclib plus letrozole increased the time patients lived without their cancer getting worse compared to letrozole alone. Additionally, in the MONALEESA-7 trial, Ribociclib combined with endocrine therapy showed a significant improvement in both the time patients lived without cancer progression and overall survival in pre- and perimenopausal women. These findings suggest that Ribociclib is an effective addition to breast cancer treatment regimens.610111213
Who Is on the Research Team?
Kari B. Wisinski
Principal Investigator
University of Wisconsin, Madison
Are You a Good Fit for This Trial?
This trial is for adults with advanced AR+ triple-negative breast cancer who haven't had certain treatments, have no active brain metastases, and whose major organs function well. They must not be pregnant or breastfeeding, agree to use contraception, and can swallow pills. Excluded are those with recent heart issues, strokes, uncontrolled conditions that could affect safety or compliance, known HIV infection or other active cancers needing treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
Dose escalation of ribociclib with bicalutamide to determine maximum tolerated dose
Phase II Treatment
Ribociclib at RP2D combined with bicalutamide for up to 4 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bicalutamide
- Ribociclib
Bicalutamide is already approved in European Union, United States, Japan, Canada for the following indications:
- Metastatic prostate cancer
- Locally advanced prostate cancer
- Metastatic prostate cancer
- Metastatic prostate cancer
- Locally advanced prostate cancer
- Metastatic prostate cancer
- Locally advanced prostate cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ruth O'Regan, M.D.
Lead Sponsor
Kari Wisinski
Lead Sponsor
University of Wisconsin, Madison
Collaborator
Big Ten Cancer Research Consortium
Collaborator
Novartis
Industry Sponsor
Vasant Narasimhan
Novartis
Chief Executive Officer since 2018
MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government
Shreeram Aradhye
Novartis
Chief Medical Officer since 2022
MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania