Carboplatin + Nab-Paclitaxel +/- Vorinostat for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vorinostat may also help carboplatin and paclitaxel albumin-stabilized nanoparticle formulation work better by making tumor cells more sensitive to the drugs. Giving chemotherapy with or without vorinostat before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.PURPOSE: This randomized phase II trial is studying how well giving carboplatin together with paclitaxel albumin-stabilized nanoparticle formulation works with or without vorinostat in treating women with breast cancer that can be removed by surgery.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as valproic acid or other histone deacetylase inhibitors, at least 4 weeks before starting. You also cannot be on any chemotherapy, radiotherapy, or endocrine therapy for this cancer, and no concurrent antiretroviral therapy if you are HIV-positive.
Is the combination of Carboplatin, Nab-Paclitaxel, and Vorinostat safe for humans?
The combination of Carboplatin and Nab-Paclitaxel has been shown to be well tolerated in elderly patients with lung cancer, with less nerve-related side effects. Additionally, a study on Paclitaxel and Vorinostat in breast cancer suggests that this combination in a specific nanoparticle form may have less toxicity compared to traditional formulations.12345
What makes the drug Carboplatin + Nab-Paclitaxel +/- Vorinostat unique for breast cancer treatment?
This drug combination is unique because it includes nab-paclitaxel, a form of paclitaxel bound to albumin (a protein in the blood), which enhances drug delivery to tumors and reduces side effects compared to traditional formulations. Nab-paclitaxel is solvent-free, minimizing the risk of allergic reactions, and has shown improved effectiveness and tolerability in breast cancer treatment.26789
What data supports the effectiveness of the drug combination Carboplatin + Nab-Paclitaxel +/- Vorinostat for breast cancer?
Research shows that nab-paclitaxel, a component of the drug combination, is effective and less toxic in treating breast cancer compared to traditional formulations. Additionally, the combination of paclitaxel and carboplatin has shown promising response rates and manageable toxicity in advanced breast cancer, suggesting potential effectiveness for this drug combination.16101112
Who Is on the Research Team?
Vered Stearns, MD
Principal Investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Are You a Good Fit for This Trial?
This trial is for women with newly diagnosed operable breast cancer. Participants should have specific types of breast cancer, meet certain blood and organ function criteria, agree to non-hormonal contraception, and not be pregnant or nursing. Those with severe complications risk, prior systemic treatment for this cancer, or other exclusions cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Run-in
Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.
Primary Study
Patients are randomized to receive either carboplatin and paclitaxel with placebo or with vorinostat. Treatment repeats weekly for 12 weeks.
Surgery
Within 2-4 weeks after completion of neoadjuvant chemotherapy, patients undergo breast conserving surgery or mastectomy.
Follow-up
Participants are monitored for safety and effectiveness after treatment.
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Paclitaxel albumin-stabilized nanoparticle formulation
- Vorinostat
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?
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
National Cancer Institute (NCI)
Collaborator