Immunotherapy for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a reduced treatment plan after surgery can effectively manage early breast cancer while minimizing side effects. It targets patients whose cancer responded completely to pre-surgery therapies, meaning no cancer cells remain in their blood. The trial includes treatments like pembrolizumab (an immunotherapy) for triple-negative breast cancer and trastuzumab (with or without pertuzumab) for HER2-positive breast cancer. Suitable candidates have early-stage triple-negative or HER2-positive breast cancer, have completed initial treatments successfully, and are open to discontinuing further standard treatments. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial requires participants to stop taking standard adjuvant systemic therapy, such as trastuzumab, pertuzumab, or pembrolizumab, after surgery. It does not specify other medications, 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?
In earlier studies, pembrolizumab helped patients with triple-negative breast cancer live longer. However, some patients experienced serious immune-related side effects, such as inflammation in the lungs or liver.
Research has shown that trastuzumab and pertuzumab are usually well-tolerated. Most side effects are mild to moderate, including diarrhea or fatigue. Serious side effects can occur but are less common.
Both treatments have approval for other uses, indicating a well-understood safety profile. While side effects can occur, they are often manageable with medical care.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they combine immunotherapy with targeted therapy to tackle breast cancer more effectively. Pembrolizumab, an immunotherapy, helps the immune system recognize and attack cancer cells, which is different from traditional chemotherapy that directly kills rapidly dividing cells. Trastuzumab and pertuzumab are targeted therapies that specifically block HER2-positive cancer cells from growing, providing a more precise approach than standard options. This combination approach aims to enhance the body's ability to fight cancer while minimizing damage to healthy cells, offering hope for improved outcomes.
What evidence suggests that this trial's treatments could be effective for breast cancer?
This trial will evaluate different immunotherapy treatments for breast cancer. Research has shown that combining pembrolizumab with chemotherapy helps patients with advanced triple-negative breast cancer (TNBC) live longer compared to chemotherapy alone. In everyday medical practice, 64.8% of patients experienced complete cancer disappearance with this combination treatment. In this trial, participants with TNBC may receive pembrolizumab as part of their treatment.
For HER2-positive breast cancer, using trastuzumab with pertuzumab has proven very effective, achieving a high survival rate of 91.6% over 10 years. This combination also reduces the risk of cancer progression or death. Participants with HER2-positive breast cancer in this trial may receive trastuzumab with or without pertuzumab. Both treatments help the immune system identify and destroy cancer cells, offering promising options for breast cancer care.678910Who Is on the Research Team?
Vicente Valero, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with early HER2+ or triple-negative breast cancer (TNBC) who've had a complete response to pre-surgery treatment and show no tumor genetic material in their blood. They must have completed specific chemotherapy regimens, undergone surgery showing no remaining cancer, and be willing to stop standard therapy.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Post-Surgery Treatment
Patients receive 1 to 3 cycles of standard of care treatment with pembrolizumab or trastuzumab with or without pertuzumab based on cohort assignment
Monitoring
Patients with negative ctDNA tests undergo monitoring with ctDNA tests every 3 months for 3 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- Pertuzumab
- Trastuzumab
Trial Overview
The study tests reduced post-surgery therapy using pembrolizumab for TNBC or trastuzumab with/without pertuzumab for HER2+ breast cancer. It aims to see if lowering therapy maintains treatment response while reducing side effects.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients may receive 1 to 3 cycles of standard of care treatment with trastuzumab with or without pertuzumab. Patients with a positive ctDNA test 4-6 weeks after surgery continue to receive standard of care treatment per their treating physician in the absence of disease progression or unacceptable toxicity. Patients with a negative ctDNA test will not receive further treatment with pembrolizumab and will undergo monitoring with ctDNA tests every 3 months for 3 years in the absence of disease progression. Patients may receive standard of care endocrine therapy per their treating physician throughout the study. Patients undergo blood sample collection throughout the study.
Patients may receive 1 to 3 cycles of standard of care treatment with pembrolizumab. Patients with a positive ctDNA test 4-6 weeks after surgery continue to receive standard of care treatment per their treating physician in the absence of disease progression or unacceptable toxicity. Patients with a negative ctDNA test will not receive further treatment with pembrolizumab and will undergo monitoring with ctDNA tests every 3 months for 3 years in the absence of disease progression. Patients undergo blood sample collection throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Citations
Pembrolizumab plus Chemotherapy in Advanced Triple ...
In this trial, first-line treatment with pembrolizumab–chemotherapy resulted in significantly longer overall survival than chemotherapy alone ...
Real-World Outcomes with the KEYNOTE-522 Regimen in ...
The 5-year survival for patients diagnosed with stage II–III TNBC is approximately 74%. Neoadjuvant systemic therapy (NAT) in stage II–III TNBC ...
Real-world safety and effectiveness of neoadjuvant ...
The effectiveness of neoadjuvant chemo-immunotherapy for the treatment of stage II-III TNBC was similar to that reported in the literature. Key ...
Real-world efficacy and adverse events of neoadjuvant ...
Median follow up was 12.3 months from the date of diagnosis. 94 pts (64.8%) attained pathological complete response (pCR). The median number of ...
Trastuzumab Deruxtecan plus Pertuzumab for HER2- ...
In this trial, trastuzumab deruxtecan plus pertuzumab showed a significant benefit in progression-free survival as compared with THP in advanced ...
Safety and clinical outcomes of pembrolizumab standard ...
This study suggests that switching to EI dosing of pembrolizumab is safe and effective in patients with breast cancer while improving medication burden for ...
Overall Survival with Pembrolizumab in Early-Stage Triple ...
The phase 3 KEYNOTE-522 trial showed significant improvements in pathological complete response and event-free survival with the addition of pembrolizumab to ...
Real-world safety and effectiveness of neoadjuvant ...
Original article. Real-world safety and effectiveness of neoadjuvant chemotherapy combination with pembrolizumab in triple-negative breast cancer.
9.
2minutemedicine.com
2minutemedicine.com/overall-survival-with-pembrolizumab-in-early-stage-triple-negative-breast-cancer/Overall Survival with Pembrolizumab in Early-Stage Triple ...
1. The 5-year OS rate for pembrolizumab vs placebo was 86.1% vs 81.7% with HR 0.51 (significant). 2. Immune-mediated adverse events grade 3 ...
Overall Survival Analysis Confirms Pembrolizumab ...
Neoadjuvant pembrolizumab added to chemotherapy significantly improves overall survival in triple-negative breast cancer and is the new standard of care.
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