Paclitaxel + Carboplatin + Pembrolizumab for Breast Cancer

AS
Overseen ByAkshara S Raghavendra, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how specific blood and imaging tests can determine if individuals with early-stage triple-negative breast cancer (TNBC) have fully responded to chemotherapy before surgery. The study involves various groups receiving combinations of chemotherapy drugs—Paclitaxel, Carboplatin, and Pembrolizumab (an immunotherapy drug)—to assess their effectiveness. Ideal participants have TNBC and can undergo combined chemotherapy and immunotherapy as part of their treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss your current medications with the study team to get specific guidance.

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

Research has shown that the combination of paclitaxel, carboplatin, and pembrolizumab is generally well-tolerated by patients. However, some individuals report side effects such as nausea, tiredness, and low blood cell counts, which can reduce energy and weaken the immune system. Studies have also found that while the treatment can be effective, it may cause serious side effects for some people. Pembrolizumab, a component of this combination, has been linked to immune-related side effects, such as inflammation in organs like the lungs or liver. These side effects might not occur in everyone, but they are important to consider. Overall, the treatment shows promise, but potential side effects should be considered when deciding to join a trial.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about combining Paclitaxel, Carboplatin, and Pembrolizumab for breast cancer because this trio offers a unique approach compared to standard chemotherapy and hormone therapy options. Pembrolizumab is an immunotherapy drug that helps the immune system detect and attack cancer cells, which is different from traditional treatments that directly target cancer cells. This combination could potentially enhance the effectiveness of chemotherapy by boosting the body's natural defenses, providing a dual attack on the cancer. Additionally, using immunotherapy like Pembrolizumab could lead to longer-lasting responses, giving patients more durable outcomes.

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

Research has shown that combining the drugs paclitaxel, carboplatin, and pembrolizumab yields promising results for treating triple-negative breast cancer (TNBC). Earlier studies demonstrated that adding pembrolizumab to chemotherapy extended patients' lives. Specifically, about 86.6% of patients with early-stage TNBC survived after receiving this treatment. In this trial, participants will join different cohorts; some will receive paclitaxel, carboplatin, and pembrolizumab alone, while others will receive additional cycles of AC/PB. Pembrolizumab-based treatments have become a common choice for early-stage TNBC due to their effectiveness. This combination is known for effectively fighting tumors and generally manageable side effects, offering hope to patients.12367

Who Is on the Research Team?

CY

Clinton Yam, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for people diagnosed with early-stage triple-negative breast cancer (TNBC) who are planning to receive chemotherapy before surgery. Participants should be healthy enough for treatment and surgery.

Inclusion Criteria

I am willing to use birth control while in the study if I am a woman of childbearing age.
I do not have active hepatitis B or C.
I agree to use reliable birth control before, during, and after the study.
See 7 more

Exclusion Criteria

Participants with cognitive impairment, psychiatric illness, or social situations limiting compliance with study requirements
I am not medically eligible to receive immunotherapy.
I have stage IV (metastatic) breast cancer.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neoadjuvant therapy with Paclitaxel, Carboplatin, and Pembrolizumab for 4 cycles, with some cohorts receiving additional AC/PB cycles

16-32 weeks

Surgery

Participants undergo surgery to assess pathological complete response (pCR)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Carboplatin
  • Paclitaxel
  • Pembrolizumab

Trial Overview

The study tests if blood and imaging tests can identify which patients have fully responded to pre-surgery chemo (paclitaxel, carboplatin) plus pembrolizumab. All participants get these treatments before their operation.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Cohort B2Experimental Treatment2 Interventions
Group II: Cohort B1Experimental Treatment2 Interventions
Group III: Cohort A2Experimental Treatment2 Interventions
Group IV: Cohort A1Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Citations

Pembrolizumab Plus Carboplatin and Paclitaxel as First- ...

Pembrolizumab plus carboplatin and paclitaxel showed promising antitumor activity and a manageable safety profile in first-line R/M HNSCC.

Pembrolizumab plus Chemotherapy in Advanced Triple ...

The addition of pembrolizumab to chemotherapy resulted in significantly longer overall survival than chemotherapy alone.

A phase Ib trial of pembrolizumab plus paclitaxel or flat-dose ...

The trial demonstrates that both regimens meet the pre-specified safety endpoint (paclitaxel: 87%; capecitabine: 100%). Objective response rate is 29% for ...

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).

Pembrolizumab-Based Regimens Gain Ground in TNBC ...

More specifically, in stage IV disease, the 5-year OS rate is approximately 14.3% in patients with TNBC, which again is significantly lower than ...

Pembrolizumab Plus Chemotherapy for Locally Recurrent ...

Pembrolizumab has warnings/precautions for immune-mediated adverse reactions (pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with ...

Carboplatin + Paclitaxel + Pembrolizumab for Breast Cancer

Research shows that patients generally tolerate this treatment well. Some have reported side effects such as nausea, tiredness, and low blood cell counts,