Carboplatin + Nab-Paclitaxel +/- Vorinostat for Breast Cancer

Recruiting at 4 trial locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

No Placebo Group

Prior Safety Data

Trial Summary

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.

Research Team

Vered Stearns, MD

Principal Investigator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria

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

My breast cancer is of the infiltrating lobular type.

My cancer is not HER2 positive.

My breast cancer is both ductal and lobular.

Exclusion Criteria

I haven't had any cancer except for skin cancer in the last 5 years.

I am currently taking medication that affects cell DNA.

I am not taking any experimental drugs.

Treatment Details

Interventions

• Carboplatin (Alkylating agents)
• Paclitaxel albumin-stabilized nanoparticle formulation (Anti-metabolites)
• Vorinostat (Histone Deacetylase Inhibitor)

Trial Overview The study tests how well carboplatin and nab-paclitaxel chemotherapy work when given with or without vorinostat before surgery. The goal is to see if adding vorinostat makes the chemo more effective in shrinking tumors in preparation for surgical removal.

Participant Groups

Group I: Arm II Experimental Treatment 3 Interventions

Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.

Group II: Arm I Active Control 3 Interventions

Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.

Carboplatin is already approved in Canada for the following indications:

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+