Carboplatin vs. Carboplatin + Everolimus for Advanced Breast Cancer

No longer 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: 3

Duration: up to 3 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares the effectiveness and safety of two treatments for advanced triple-negative breast cancer, a type of breast cancer lacking certain receptors. One group will receive carboplatin alone, a common chemotherapy drug, while the other group will receive a combination of carboplatin and everolimus, a drug that may help stop cancer growth. Women with advanced breast cancer that has spread to other parts of the body and meet specific criteria might be suitable for this study. As a Phase 2 trial, the research focuses on measuring how well the treatment works in an initial, smaller group of people.

Do I have to stop taking my current medications to join the trial?

The trial requires that you stop taking any anticancer therapies at least 2 weeks before starting the study drug. If you are on corticosteroids, you must be on a stable dose for at least 4 weeks before starting Everolimus. Also, you cannot take certain medications that strongly interact with the study drugs, so you should discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using carboplatin and everolimus together is generally safe for treating advanced triple-negative breast cancer. In past studies, patients handled the treatment well. For example, one study found that this combination lowered the risk of cancer progression or death by 52%. Another study confirmed its safety and effectiveness, showing a good rate of clinical benefit in patients with metastatic cancer.

These results suggest that the treatment is promising with manageable side effects. However, individual experiences may vary, and some people might react differently. Always consult a healthcare provider about any concerns or questions before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Carboplatin and Everolimus for advanced breast cancer because it offers a unique approach compared to traditional treatments like hormone therapy or chemotherapy alone. Carboplatin, a chemotherapy drug, is already used to treat breast cancer by damaging the DNA of cancer cells, leading to their death. However, adding Everolimus, which is an mTOR inhibitor, introduces a new dimension by targeting the cancer cells' growth pathways, potentially making the treatment more effective. This combination could enhance the effectiveness of chemotherapy and help overcome resistance that often develops with standard treatments. This innovative dual-action strategy holds promise for improving outcomes in advanced breast cancer patients.

What evidence suggests that this trial's treatments could be effective for advanced breast cancer?

This trial will compare the effectiveness of carboplatin alone to carboplatin combined with everolimus for advanced breast cancer. Research has shown that combining carboplatin with everolimus may help treat advanced triple-negative breast cancer (TNBC). One study found that this combination reduced the risk of cancer progression or death by 52%, allowing patients to live longer without their cancer worsening. The treatment was well tolerated, causing few side effects. Adding everolimus to carboplatin significantly extended the time patients lived without cancer progression. Overall, evidence suggests this combination could be a beneficial option for those with advanced TNBC. ^{1 2 3 4 5}

Who Is on the Research Team?

Amy D. Tiersten

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either carboplatin alone or carboplatin with everolimus for the treatment of advanced triple-negative breast cancer

up to 3 years

Every 3 weeks for IV infusion

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 3 years

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40817986/

Randomized phase II comparison of single-agent carboplatin ... The combination of carboplatin and everolimus in this study reduced the risk of progression or death by 52%. The regimen was well tolerated ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02531932

NCT02531932 | Comparison of Single-Agent Carboplatin ... The purpose of this study is to evaluate the safety and effectiveness of carboplatin compared to the combination of carboplatin and everolimus for the ...

3. mountsinai.org mountsinai.org/about/newsroom/2025/combination-therapy-improves-outcomes-for-advanced-triple-negative-breast-cancer

triple-negative breast cancer “Our findings suggest that the combination of carboplatin and everolimus could offer a new option for patients, and should be further tested in ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4053575/

Phase 2 trial of everolimus and carboplatin combination in ... We demonstrated the efficacy of the combination of everolimus with carboplatin in triple-negative metastatic breast cancer. Everolimus 5 mg daily given orally ...

5. medscape.com medscape.com/viewarticle/everolimus-plus-carboplatin-shows-promise-tnbc-2025a1000mzb

Everolimus Plus Carboplatin Shows Promise in TNBC A phase 2 study finds that adding everolimus to carboplatin is associated with a significant increase in progression-free survival.