Carboplatin + Paclitaxel + Pembrolizumab for Breast Cancer

(NeoCARD Trial)

Overseen By Abirami Sivapiragasam

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Medical University of South Carolina

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Metastatic cancer, Autoimmune disease, HIV, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12-18 weeks

43 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of drugs—carboplatin, paclitaxel, and pembrolizumab (an immunotherapy)—to evaluate their effectiveness on triple-negative breast cancer (TNBC) that cannot be treated with certain heart-risky drugs. It targets individuals with a breast tumor larger than 1 cm, who have not previously undergone chemotherapy or major treatments for this breast cancer, and who have heart conditions that make other treatments unsafe. The goal is to determine if this drug combination can effectively shrink the cancer before surgery. Participants must be medically fit for surgery and able to work closely with a doctor for heart health monitoring. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you must be able to be followed by a cardiologist or primary care physician for medication optimization of cardiac conditions, and there is a 7-day clearance period for immunosuppressant therapy if applicable.

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

Previous studies have tested the combination of carboplatin, paclitaxel, and pembrolizumab in patients with triple-negative breast cancer (TNBC). Research shows that patients generally tolerate this treatment well. Some have reported side effects such as nausea, tiredness, and low blood cell counts, which are common with many cancer treatments. Importantly, adding pembrolizumab to this combination has become a standard method for treating early-stage TNBC, indicating that experts consider it relatively safe and effective. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of carboplatin, paclitaxel, and pembrolizumab for treating triple-negative breast cancer (TNBC) because it uniquely integrates chemotherapy with immunotherapy. While standard treatments like chemotherapy target fast-growing cancer cells, pembrolizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells more effectively. This dual approach not only targets the cancer directly but also empowers the body's own defenses, potentially leading to better outcomes for patients with advanced stages of TNBC.

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

Research has shown that using carboplatin, paclitaxel, and pembrolizumab together may effectively treat triple-negative breast cancer (TNBC). Earlier studies demonstrated that combining pembrolizumab with chemotherapy improved survival rates, with about 86.6% of early-stage TNBC patients living for at least five years. Real-world evidence suggests that pembrolizumab makes the cancer less detectable after treatment. Using this combination before the main treatment has yielded good results in shrinking tumors and is considered safe. This approach could be a strong option for those unable to use traditional anthracycline-based therapies. Participants in this trial will receive this combination to evaluate its effectiveness and safety in treating TNBC. ^{4 6 7 8 9}

Who Is on the Research Team?

Abi Siva, MD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for adults with triple-negative breast cancer who can't have anthracycline-based therapy due to heart issues. They must be fit for surgery, have a tumor larger than 1cm, and be able to work with a cardiologist or PCP. Participants need to consent in writing and follow study procedures.

Inclusion Criteria

I am 18 years old or older.

Ability and willingness to comply with all study procedures

My nerve damage does not severely limit my daily activities.

Exclusion Criteria

Planning to participate, currently participating in, or has participated in a study of an investigational agent or used an investigational device within 4 weeks prior to the first dose of study treatment

My condition is metastatic or inflammatory breast cancer.

I cannot have surgery to cure my condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-18 week neoadjuvant regimen of carboplatin, paclitaxel, and pembrolizumab (CPP) in a response-adaptive manner

12-18 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term Follow-up

Participants are monitored for event-free survival and overall survival

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Carboplatin
• Paclitaxel
• Pembrolizumab

Trial Overview The trial tests an Anthracycline-Free Chemoimmunotherapy regimen using Carboplatin, Paclitaxel, and Pembrolizumab (CPP) over 12-18 weeks before surgery in patients with triple-negative breast cancer. It's a Phase II study across multiple institutes.

How Is the Trial Designed?

Group I: TNBC + non inflammatory Stage 2 3A/B Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39282906/

Overall Survival with Pembrolizumab in Early-Stage Triple ... The estimated overall survival at 60 months was 86.6% (95% confidence interval [CI], 84.0 to 88.8) in the pembrolizumab-chemotherapy group, as ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa1910549

Pembrolizumab for Early Triple-Negative Breast Cancer Previous trials showed promising antitumor activity and an acceptable safety profile associated with pembrolizumab in patients with early triple-negative ...

3. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2812294

Clinical and Biomarker Findings of Neoadjuvant ... This single-group phase 2 clinical trial including 115 evaluable women with TNBC found that neoadjuvant pembrolizumab plus carboplatin and docetaxel showed an ...

4. keytrudahcp.com keytrudahcp.com/efficacy/early-stage-triple-negative-breast-cancer/

KEYNOTE-522 - Clinical Trial Results | HCP - Keytruda Health care professionals may view findings from KEYNOTE-522, a clinical trial for patients with high-risk early-stage triple-negative breast cancer (TNBC).

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0748798325004391

Real-world evidence of the efficacy of neoadjuvant ... Neoadjuvant pembrolizumab has shown efficacy in improving pathologic complete response (pCR) rates and survival outcomes in triple-negative breast cancer (TNBC) ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40233520/

Real-world evidence of the efficacy of neoadjuvant ... Neoadjuvant pembrolizumab has shown efficacy in improving pathologic complete response (pCR) rates and survival outcomes in triple-negative breast cancer (TNBC ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06407310

Neoadjuvant Pembrolizumab, Carboplatin and Paclitaxel ... This is a phase II, single-centered, open-label, single-armed study in patients with early triple-negative breast cancer that will evaluate the pathological ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2949820124000390

Real-world safety and effectiveness of neoadjuvant ... Neoadjuvant chemotherapy (NAC) with the addition of pembrolizumab has become the standard of care for early-stage II-III triple-negative breast cancer (TNBC).

9. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.2025.43.16_suppl.e12606

Neoadjuvant dose-dense anthracycline and ... This meta-analysis assesses the efficacy and safety of ddAC in combination with CT and pembrolizumab.