Paclitaxel + Carboplatin + Pembrolizumab for Breast Cancer
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive neoadjuvant therapy with Paclitaxel, Carboplatin, and Pembrolizumab for 4 cycles, with some cohorts receiving additional AC/PB cycles
Surgery
Participants undergo surgery to assess pathological complete response (pCR)
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Cohort B2 Omiting AC/PB: Paclitaxel+Carboplatin+Pembrolizumab x 4 cycles
Cohort B1 Receiving AC/PB: Paclitaxel+Carboplatin+Pembrolizumab x 4 cycles + (AC/PB) x 4 cycles
Cohort A2 Receiving AC/PB: Paclitaxel+Carboplatin+Pembrolizumab x 4 cycles + (AC/PB) x 4 cycles
Cohort A1 Omiting AC/PB: Paclitaxel+Carboplatin+Pembrolizumab x 4 cycles
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
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,
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