“These trials are very important because breast cancer is a significant issue in Hawaiʻi,” Randall Holcombe, director of the UH Cancer Center said in a press release. “Racial and ethnic minority groups are severely under-represented in breast cancer clinical trials in the rest of the United States, so participation of patients from Hawaiʻi is doubly important.”
The two trials are being coordinated by the university, but patients will be enrolled at sites across the U.S. and some parts of Canada.
A Phase 3 trial (NCT02927249), called Aspirin Breast Cancer (ABC), currently recruiting participants, will assess if aspirin may help prevent cancer from recurring in patients with node-positive, human growth factor receptor 2 (HER2)-negative breast cancer.
Patients in the trial must have received standard therapy — which usually involves sequential chemotherapy to shrink the tumor, surgery to remove it, and radiation therapy to eliminate any potentially remaining cancer cells and prevent relapse.
The trial aims to recruit 2,936 participants, who will be randomly assigned oral aspirin (300 mg), or a placebo, given daily for five years.
As a primary objective, researchers will assess the time patients live without any signs or symptoms of invasive disease — a measure called invasive disease-free survival. Secondary goals include overall survival, time until disease metastasis or death, and incidence of cardiovascular events.
“There is significant data to support the potential benefits of aspirin in breast cancer survivors,” said Jessica Rhee, medical director of the UH Cancer Center Clinical Trials Office. “Aspirin is inexpensive and widely available, so this treatment could be used worldwide to improve breast cancer outcomes. The results will help determine if aspirin can become part of routine care for breast cancer patients. The only way to evaluate this is to conduct this very important clinical trial.”
The second Phase 3 trial (NCT03233191), called the Tomosynthesis Mammographic Imaging Screening Trial (TMIST), also recruiting participants, aims to determine if tomosynthesis, also known as 3D mammography, is better than regular 2D mammograms at diagnosing breast cancer and reducing the number of deaths caused by the disease.
Regular and 3D mammograms are both conducted the same way, from the patient’s point of view. In both cases, the breasts are compressed between two plates and X-ray radiation helps doctors visualize abnormalities.
However, while 2D mammograms only take images from the front and side, which may create images with overlapping breast tissue, 3D mammography provides images from many different angles, finding abnormalities and determining if they are potentially worrisome with more accuracy than regular scans.
But even though 3D mammograms have been approved in the U.S. since 2012, 2D scans are still the standard method for diagnosing breast cancer, because doctors are concerned the new approach will lead to overdiagnosis and overtreatment.
The trial aims to enroll roughly 165,000 women without a personal history of breast cancer, who will be randomly assigned 2D or 3D mammography. The procedures will be conducted every year for premenopausal women, and every two years for post-menopausal women.
Researchers will then examine the proportion of patients diagnosed with breast cancer in the 4.5 years that follow randomization. Secondary measures include agreement among pathologists, breast cancer-specific deaths, and healthcare costs.
“The best way to improve breast cancer care that leads to better outcomes for patients is to increase enrollment for clinical trials that test new ways of preventing, diagnosing and treating cancer. Findings from these clinical trials could establish new and improved standards of care,” Rhee said.