Multiple new clinical studies on breast cancer have recently begun recruiting participants. Perhaps one of your patients could benefit from enrolling in one of these trials?
Treatment-naive early-stage triple-negative breast cancer
Adults with this type of breast cancer are eligible for a randomized, open National Cancer Institute (NCI)-supported phase 3 study to investigate whether an anthracycline-free, shorter neoadjuvant chemoimmunotherapy is as effective as standard chemoimmunotherapy. Before surgery, one group of participants will receive two rounds of intravenous anthracycline-based chemotherapy plus intravenous pembrolizumab (Keytruda), while the other group will receive only one round of taxane-platinum chemotherapy plus pembrolizumab. Recruitment for the 2400 participants began in September 2023 across locations in 37 US states and Puerto Rico. The primary endpoint is event-free survival in breast cancer, adjusted for lymph node status and stromal tumor-infiltrating lymphocyte enrichment. Overall survival and quality of life (QOL) are secondary endpoints. More details on ClinicalTrials.gov.
Postoperative ER+/HER2-early-stage breast cancer with moderate to high risk of recurrence
Women and men in this situation are being recruited for a randomized, open phase 3 study to determine whether an experimental oral selective estrogen receptor degrader (SERD), Camizestrant (AstraZeneca), can better prevent breast cancer recurrence than standard endocrine therapy. The study involves up to 7 years of treatment with either standard oral endocrine therapy or oral Camizestrant, with or without Abemaciclib, followed by 10 years of observation after the last patient is recruited. The study opened in October 2023 for 5500 participants in centers in several locations, with more to follow. The primary endpoint is survival without invasive breast cancer, while secondary endpoints include overall survival and quality of life. More details on ClinicalTrials.gov.
Unilateral segmental mastectomy scheduled for early-stage breast cancer
Individuals in this situation who can read, write, and speak English or Spanish may be eligible for a randomized, open phase 2/3 study supported by the National Institutes of Health investigating whether nurse-led hypnosis (hypnosedation) can reduce the number of surgical interventions and opioid use related to axillary lymph node dissection or sentinel lymph node biopsy. The MD Anderson Cancer Center began recruiting participants in October 2023. The study’s primary endpoint is the reduction in morphine consumption during the two weeks following the operation, with secondary endpoints including cost reductions and patient-reported outcomes. More details on ClinicalTrials.gov.
And more studies on different types of breast cancer are ongoing.
*All study information is from the National Institutes of Health’s US National Library of Medicine (available online at ClinicalTrials.gov). Kathy Miller, MD, was not involved in any of these processes.*