Carboplatin vs. Carboplatin + Everolimus for Advanced Breast Cancer

Recruiting at 2 trial locations

Overseen By Amy Tiersten, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: amy tiersten

Must not be taking: CYP3A4 inhibitors, PgP inhibitors

Disqualifiers: Uncontrolled brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

64 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and effectiveness of carboplatin compared to the combination of carboplatin and everolimus for the treatment of advanced triple-negative breast cancer (TNBC). Study close to accrual

Research Team

Amy D. Tiersten

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

This trial is for women over 18 with advanced triple-negative breast cancer, including those with stable brain metastases. Participants can have had up to three prior treatments and must have good organ function and performance status. Pregnant or breastfeeding women, individuals on certain drugs, or those with severe medical conditions are excluded.

Inclusion Criteria

I am a woman with breast cancer that has spread, including to bones.

My kidney function is normal, with creatinine levels within the acceptable range.

My breast cancer is triple negative.

Exclusion Criteria

I haven't had any cancer in the past 3 years, except for treated skin cancer or cervical cancer.

Prior treatment with any investigational drug within the preceding 2 weeks

I haven't had any cancer treatments in the last 2 weeks.

Treatment Details

Interventions

• Carboplatin
• Everolimus

Trial Overview The study compares the effectiveness of Carboplatin alone versus a combination of Carboplatin and Everolimus in treating advanced triple-negative breast cancer. The goal is to determine which treatment is safer and more effective.

Participant Groups

Group I: Carboplatin + Everolimus Experimental Treatment 2 Interventions

Carboplatin AUC 4 every 3 weeks IV infusion plus daily oral everolimus 5mg pill

Group II: Carboplatin alone Active Control 1 Intervention

AUC 4 every 3 weeks as an IV infusion

Carboplatin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Paraplatin for:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

amy tiersten

Lead Sponsor

Trials

1

Recruited

60+

Amy Tiersten

Lead Sponsor

Trials

2

Recruited

70+

Novartis

Industry Sponsor

Trials

1,646

Recruited

2,778,000+

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