For some women diagnosed with stage zero breast cancer, treatment can mean surgery even if the disease has not spread beyond the milk ducts.
Now, Montefiore Einstein Comprehensive Cancer Center (MECCC) is participating in a national clinical trial examining whether some patients with DCIS can instead be treated with medication and close monitoring, potentially avoiding surgery unless the disease shows signs of progressing.
Sheldon M. Feldman, M.D., chief of the Division of Breast Surgery and Breast Surgical Oncology and director of Breast Cancer Services at MECCC, is the principal investigator for the Montefiore site of the Re-Evaluating Conditions for Active Surveillance Suitability as Treatment (RECAST) trial.
The Phase 2 study, which is being conducted through the I-SPY research network, is expected to enroll about 400 patients across roughly 20 sites nationwide. Montefiore’s site is beginning the trial this month.
DCIS is a breast condition in which atypical cells with a cancer-like appearance are contained within the lining of the milk ducts. Unlike invasive breast cancer, the cells have not broken through the duct and cannot spread throughout the body. DCIS is classified as stage zero breast cancer, and its prognosis approaches 100% in terms of cure, Feldman said.
But the challenge for doctors is determining which cases are likely to remain contained and which could eventually progress to invasive cancer.
“That’s where there’s been a lot of healthy debate amongst the scientists about will all patients who have this DCIS develop invasive cancer, or might some of them never develop invasive cancer?” Dr. Feldman said.
DCIS can also be categorized as low, intermediate or high grade, depending on the cells’ appearance under a microscope. As a result, patients diagnosed with DCIS can face a range of treatment options, including active surveillance, anti-estrogen medication, lumpectomy, radiation and mastectomy.
That range of options, combined with the word “cancer” in the diagnosis, can make DCIS particularly frightening for patients. But Feldman said patients should be able to make treatment decisions based on a clear understanding of their diagnosis and the available options.
“I think most of us believe that the vast majority of patients are sort of terrified when they’re diagnosed with any kind of breast problem,” said Dr. Feldman. “If it’s cancer or ductal carcinoma in situ, even at stage zero, a lot of patients feel that ‘Unless I do something really drastic, I could die from this.’”
“Now some patients will decide, even with the information that I present, that for them they just feel safer, more comfortable, having surgery, potentially even having both breasts removed. It’s ultimately the patient’s choice, but I think they need to be making decisions with the best medical information that’s truly correct.”
The RECAST trial will study adults diagnosed with DCIS who have estrogen receptor-positive disease, meaning the abnormal cells respond to estrogen. Participants undergo a specialized MRI before beginning treatment and are randomly assigned to one of four medical treatment approaches.
Instead of immediately undergoing surgery, patients receive medication and are monitored through follow-up MRIs.
After three months, patients receive another MRI. If the disease is stable or has improved, they continue treatment and receive another MRI at six months. If the disease shows signs of progression, the patient undergoes surgery.
The approach does not eliminate surgery as an option altogether. Instead, the trial is testing whether surgery can be reserved for patients whose disease does not respond adequately to medication.
“We think it’s a very safe trial,” Feldman said.
The trial builds on earlier research, including the COMET trial, in which MECCC also participated. COMET randomized patients with DCIS to surgery or active surveillance, with endocrine therapy allowed but not required. Three-year results showed comparable outcomes between the groups, although the results remain relatively early, Feldman said.
That research is reflective of a broader shift in breast cancer treatment, determining whether less invasive approaches can provide the same outcomes for appropriately selected patients.
For much of the 20th century, mastectomy was a common treatment for breast cancer. But beginning in the 1960s, under the backdrop of the women’s rights movement, patients and advocates increasingly challenged the way breast cancer was treated and called for women to have a greater voice in decisions about their care.
Now, researchers are asking a similar question about DCIS: whether some patients can safely avoid surgery altogether.
If the RECAST trial confirms that some patients can be safely treated with medication and monitoring, it could change the way DCIS is initially managed, Feldman said. Instead of automatically undergoing surgery, some patients could begin with medication and imaging, with surgery reserved for those whose disease does not respond.
The trial could also help researchers determine which medications are most effective and whether newer treatments can offer fewer side effects than existing therapies.
“Ultimately, it’s the patient’s choice,” he said, emphasizing the importance of making that decision with accurate medical information.
The RECAST trial is expected to continue for another two to three years, with full publication of the study results likely to come later.
Reach Marina Samuel at msamuel@schnepsmedia.com. For more coverage, subscribe to our newsletter and follow us on Twitter, Facebook and Instagram!
