Carboplatin +/- Tocilizumab for Breast Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot use methotrexate or certain corticosteroids. Hormone therapy must be stopped at least 2 weeks before joining the trial.
What data supports the effectiveness of the drug Carboplatin in treating breast cancer?
Research shows that Carboplatin, when used in combination with other drugs like paclitaxel, has shown promising results in treating advanced breast cancer, with response rates of 40-60% and manageable side effects. Additionally, Carboplatin has been effective in increasing complete response rates in aggressive breast cancers, especially in patients with certain genetic mutations.12345
Is the combination of Carboplatin and Tocilizumab safe for humans?
Carboplatin is generally well-tolerated in humans, with mild side effects like nausea and low blood cell counts. Tocilizumab, used for other conditions, is also considered safe but can cause side effects like infections and liver enzyme changes. While specific safety data for the combination of Carboplatin and Tocilizumab in breast cancer is limited, both drugs have been used safely in humans for other conditions.13678
What makes the drug combination of Carboplatin and Tocilizumab unique for breast cancer treatment?
The combination of Carboplatin and Tocilizumab is unique because it pairs a chemotherapy drug (Carboplatin) with an immunotherapy drug (Tocilizumab), which is typically used to treat inflammation in conditions like rheumatoid arthritis. This novel approach aims to enhance the immune response against breast cancer, potentially offering a new treatment option for patients.123910
What is the purpose of this trial?
This is a randomized Phase II study of standard of care (SOC) chemotherapy monotherapy vs. SOC chemotherapy combined with tocilizumab in in Black and non-Black patients with metastatic triple negative or ER low breast cancer.
Research Team
Kathy Miller, MD
Principal Investigator
Indiana University
Eligibility Criteria
This trial is for adults with metastatic triple negative or ER-low breast cancer who have completed prior therapy at least a year ago. They must be in good physical condition, have adequate organ function, and not be pregnant. Participants need to consent to biopsies and agree to use effective contraception. Those with treated brain metastases may join if stable.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either SOC chemotherapy monotherapy or SOC chemotherapy combined with tocilizumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Carboplatin
- Tocilizumab
Carboplatin is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
- Ovarian cancer
- Small cell lung cancer
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kathy Miller
Lead Sponsor
Breast Cancer Research Foundation
Collaborator
Susan G Koman for the Cure Breast Cancer Foundation
Collaborator
Genentech, Inc.
Industry Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD