US/PA/E Imaging for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to assess how well triple-negative breast cancer responds to treatment before surgery. It combines ultrasound, photoacoustic, and elasticity imaging to provide an early view of tumor reactions to chemotherapy and immunotherapy. This approach could help doctors determine sooner if the treatment is effective. Individuals with stage II-III triple-negative breast cancer, who show no signs of cancer spreading and are scheduled to receive standard treatments—including chemotherapy drugs like Carboplatin, Cyclophosphamide, Doxorubicin, and Paclitaxel, as well as the immunotherapy drug Pembrolizumab—might be suitable candidates for the trial. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
What prior data suggests that US/PA/E imaging is safe for early identification of tumor response in breast cancer patients?
Research has shown that the treatments in this trial carry some risks, but they are generally manageable. For example, past studies found the combination of doxorubicin and cyclophosphamide to be safe and tolerable. However, adding pembrolizumab to chemotherapy can lead to serious side effects, including a few deaths. In one study, 17.5% of patients experienced severe side effects, though most were mild to moderate and manageable.
Additionally, treatments with drugs like carboplatin and paclitaxel often cause side effects. One study reported that most side effects were mild, such as nausea, but serious problems occurred in a few cases.
While these treatments effectively combat cancer, they come with risks. Potential participants should understand these risks and discuss them with their healthcare provider.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores the potential of advanced imaging techniques to enhance breast cancer treatment. Unlike standard imaging methods, this trial uses novel US/PA/E imaging, which combines ultrasound with photoacoustic and elastography imaging. These techniques can provide more detailed insights into tumor characteristics and treatment response, potentially allowing for more personalized and effective treatment plans. By integrating these cutting-edge imaging tools with the current treatments of carboplatin, cyclophosphamide, doxorubicin, paclitaxel, and pembrolizumab, researchers hope to improve early detection of treatment effectiveness and adapt strategies accordingly.
What evidence suggests that US/PA/E imaging is effective for early identification of tumor response in triple-negative breast cancer?
Research has shown that using carboplatin, pembrolizumab, and paclitaxel together effectively treats triple-negative breast cancer. Studies have found that this combination can significantly shrink tumors before surgery. In this trial, participants will receive this combination as part of the standard-of-care regimen.
For the treatment with doxorubicin, cyclophosphamide, and pembrolizumab, evidence also suggests it works well. Specifically, one study found that this treatment made the cancer disappear in 58% of patients, meaning more than half showed no signs of cancer after treatment. Participants in this trial will also receive this combination as part of the standard-of-care regimen. Both treatment plans show promise for managing this aggressive type of breast cancer.678910Who Is on the Research Team?
Kevin Kalinsky, MD, MS, FASCO
Principal Investigator
Emory University Hospital/Winship Cancer Institute
Are You a Good Fit for This Trial?
This trial is for people with stage II or III triple-negative breast cancer who are about to start chemotherapy and immunotherapy before surgery. Participants should be able to undergo imaging tests and treatment as planned.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive neoadjuvant immunotherapy and chemotherapy, including US/PA/E imaging at baseline, week 4, and week 7, and prior to cycles 1 and 2 of SOC doxorubicin, cyclophosphamide, pembrolizumab regimen, as well as prior to SOC surgery.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Cyclophosphamide
- Doxorubicin
- Paclitaxel
- Pembrolizumab
Trial Overview
The study is testing whether advanced ultrasound, photoacoustic, and elasticity imaging can detect early tumor response in patients receiving standard chemo (carboplatin, doxorubicin, cyclophosphamide, paclitaxel) plus pembrolizumab (immunotherapy) before surgery.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients undergo US imaging using the Vevo F2 device and PA/E imaging using the Vevo LAZR-X20 device prior to and at week 4 and week 7 of SOC carboplatin, pembrolizumab, and paclitaxel regimen, prior to cycles 1 and 2 of SOC doxorubicin, cyclophosphamide, pembrolizumab regimen, as well as prior to SOC surgery. Patients also undergo breast MRI on study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Breastcancer.org - Breast Cancer Information and Support
We are your go-to resource for clear, reliable, accurate, and up-to-date breast cancer information as well as community support. Facts and statistics
Breast Cancer - NCI
Explore the links on this page to learn more about breast cancer prevention, screening, treatment, statistics, research, clinical trials, and more.
Breast cancer
The chemotherapy regimens available today are very effective in reducing the chances of cancer spread or recurrence and are generally given as ...
Breast Cancer
Here you can find out more about breast cancer, including risk factors, symptoms, how it is found, and how tumors are diagnosed and treated. ...
Sulforaphane, a dietary component of broccoli ... - PubMed
Sulforaphane (1-5 micromol/L) decreased aldehyde dehydrogenase-positive cell population by 65% to 80% in human breast cancer cells. These ...
Dose dense doxorubicin plus cyclophosphamide in a ...
ddAC in a modified KN522 regimen is safe, tolerable, and effective. Efficacy is comparable regardless of chemotherapy sequencing, but ddAC first ...
7.
oncpracticemanagement.com
oncpracticemanagement.com/issues/2022/may-2022-vol-12-no-5/pembrolizumab-plus-chemotherapy-for-neoadjuvant-and-adjuvant-therapy-in-early-triple-negative-breast-cancer-keynote-522Pembrolizumab plus Chemotherapy for Neoadjuvant and ...
Treatment-related AEs led to 4 deaths in the pembrolizumab arm and to 1 death in the placebo arm. “The results of this trial support the use of pembrolizumab ...
8.
unclineberger.org
unclineberger.org/peroulab/wp-content/uploads/sites/1008/2015/04/CALGB-40603-Sikov-JCO-2014.pdfCALGB-40603-Sikov-JCO-2014.pdf
60% of patients who received carboplatin achieved pCR breast compared with 46% of those who did not (odds ratio [OR], 1.76;
Phase II Clinical Trial of Pembrolizumab and Chemotherapy ...
Safety Treatment-related AEs were observed in 24 patients (80%); most were classified as grade 1–2 (Table 2). The most common grade 1 AEs were nausea (70%), ...
Pembrolizumab plus chemotherapy for first-line treatment ...
A summary of safety outcomes, which were reported by four trials, is provided in Supplementary Table 11. were statistically superior to that of carboplatin (HR ...
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