Several new clinical trials in breast cancer have started recruiting in recent months. Perhaps one of your patients could benefit from enrolling?
Treatment-Naive Early-Stage Triple-Negative Breast Cancer
Adults with this type of breast cancer are eligible for a randomized, open-label, phase 3 National Cancer Institute (NCI)–supported study testing whether anthracycline-free, shorter chemoimmunotherapy in the neoadjuvant setting is just as effective as usual chemoimmunotherapy.
Before surgery, one group of participants will receive two rounds of intravenous anthracycline-based chemotherapy plus intravenous pembrolizumab (Keytruda). The other group will receive just one round of taxane-platinum chemotherapy plus pembrolizumab.
Recruitment for the trial's 2400 participants started in September 2023 at sites in 37 US states and Puerto Rico. The primary outcome measure is breast cancer event–free survival, adjusted for nodal status and stromal tumor infiltrating lymphocytes enrichment. Overall survival and quality of life (QOL) are secondary measures. More details at ClinicalTrials.gov
This study is "really important," Kathy Miller, MD, a Medscape contributor and professor of oncology and medicine at the Indiana University School of Medicine, Indianapolis, said. The study has, in effect, an "embedded biomarker," said Miller, because it examines how stromal tumor infiltrating lymphocyte enrichment, a known predictor of treatment success, may impact the benefit of more extensive chemotherapy.
Postsurgical ER+/HER2- Early Breast Cancer With Intermediate-High or High Risk for Recurrence
Women and men in this situation are being recruited for a randomized, open-label phase 3 trial to determine whether an experimental oral selective estrogen receptor degrader (SERD), camizestrant (AstraZeneca), is better than standard endocrine therapy at holding off breast cancer recurrence.
Currently available SERDs — elacestrant (Orserdu) and fulvestrant (Faslodex) — are approved only for advanced breast cancer, which means this study could lead to a new treatment option.
For up to 7 years, participants will take either standard oral endocrine therapy or oral camizestrant, with or without abemaciclib in both scenarios. Everyone will be followed for 10 years after the last patient is recruited.
The study opened for 5500 participants in October 2023 at centers in Georgia, South Carolina, Tennessee, Canada, and the United Kingdom, with sites opening in 13 other US states and 38 countries. The primary outcome is invasive breast cancer–free survival. QOL and overall survival are secondary outcomes. More details at ClinicalTrials.gov
Miller explained that "toxicity will be key" here because the study evaluates SERDs in the adjuvant setting instead of in patients with advanced disease. Data from metastatic breast cancer suggest that not all SERDs are the same, she added.
Early Breast Cancer Scheduled for Unilateral, Segmental Mastectomy
People in this situation who can read, write, and speak English or Spanish may be eligible for a randomized, open-label phase 2/3 study supported by the National Institutes of Health evaluating whether nurse-delivered hypnosis (hypnosedation) can reduce surgery-related opioid use.
One group of participants will undergo surgery under a standard general anesthetic. A second group will receive hypnosedation before surgery, then standard general anesthesia. The final group of people will be provided hypnosedation throughout surgery along with local anesthesia and medications for pain and nausea.
The MD Anderson Cancer Center in Houston started welcoming the study's 225 participants in October 2023. The primary outcome measure is reduction in morphine use during the 2 weeks after surgery. Secondary outcomes are cost reduction and patient-reported outcomes that include anxiety, pain, fatigue, and cognitive dysfunction. More details at ClinicalTrials.gov
Miller applauded this, and any, strategy to reduce opioid use, sharing worries that " use of narcotics after breast surgery can lead to persistent use in some patients."
Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
Adults with this diagnosis who have already tried an aromatase inhibitor plus ribociclib (Kisqali) or palbociclib (Ibrance) may be interested in a randomized, open-label phase 3 trial to see whether lasofoxifene plus abemaciclib can slow disease progression better than the current standard, fulvestrant plus abemaciclib.
Lasofoxifene is an experimental oral selective estrogen receptor modulator previously developed for osteoporosis. For up to approximately 3 years, all participants will take twice-daily tablets of abemaciclib. One group will add on daily tablets of lasofoxifene, and the other group will receive monthly intramuscular fulvestrant injections.
Study centers in California, Florida, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, and Oklahoma started recruiting for 400 people in October 2023, with sites in 13 US states and worldwide soon to follow. Progression-free survival is the primary outcome. Overall survival over approximately 3 years and QOL are secondary outcomes. More details at ClinicalTrials.gov
Miller called the study "ho-hum" because the study comparator was intramuscular fulvestrant, and she wondered whether anyone will care about the results in the oral SERD era.
Breast Cancer Scheduled for Unilateral Axillary Lymph Node Dissection or Sentinel Lymph Node Biopsy
Women in this clinical situation who are under 76 years old and can speak English might be interested in a single-group, open-label, phase 3 study testing an approach designed to prevent lymphedema after surgery.
During surgery, all participants will receive immediate lymphatic reconstruction. For 3 months after the procedure or the completion of any adjuvant treatments, all participants will wear a compression garment for at least 8 hours a day and carry out self-directed lymphatic massage and range-of-motion exercises three times weekly.
Memorial Sloan Kettering Cancer Center started recruiting 285 participants at sites across New Jersey and New York in November 2023. The primary endpoint is increase in arm volume during the 2 years after surgery. Overall survival and QOL will not be tracked. More details at ClinicalTrials.gov
"Despite reduction in the use of axillary dissection, lymphedema remains a problem," said Miller. "Comprehensive prevention strategies remain relevant."
Early-Stage HER2- Breast Cancer
Patients aged 65 or over with this type of breast cancer who are at high-risk for severe chemotherapy toxicity may be eligible for a phase 2 randomized, blinded study. Patients with a Cancer and Aging Research Group–Breast Cancer (CARG-BC) score of 6 or more will be considerer high-risk for severe chemotherapy toxicity.
This trial will evaluate the performance of a lower dose of docetaxel compared with the standard dose. Chemotherapy with docetaxel plus cyclophosphamide is standard treatment for early-stage breast cancer but is often not well-tolerated by older patients.
In the study, approximately half the group will receive intravenous dose-reduced docetaxel and cyclophosphamide every 3 weeks for four cycles or until unacceptable toxicity or disease progression, whichever happens first. The other participants will receive standard-dose docetaxel and cyclophosphamide on the same schedule.
City of Hope Medical Center in Duarte, California, started recruiting for the trial's 174 participants in December 2023. Relative dose intensity compared with the standard dose is the primary outcome; overall survival is a secondary outcome, and QOL factors except satisfaction with treatment are not being assessed. More details at ClinicalTrials.gov
All trial information is from the National Institutes of Health US National Library of Medicine (online at ClinicalTrials.gov). Miller was not involved with any of these trials.
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New Trials in Breast Cancer: Could Your Patient Benefit? - Medscape
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