Is Surgery the Only Option for Women With Stage 0 Breast Cancer?

Imagine the stress of an abnormal mammogram finding. Then the sense of hope when the doctor explains your diagnosis: ductal carcinoma in situ (DCIS), or noninvasive stage 0 breast cancer. The cancer has been caught at its earliest stage. But then comes the recommendation: surgery.

This is a common scenario women face when diagnosed with DCIS, explains Laura Kruper, MD, a surgeon in the Breast Oncology Department at Moffitt Cancer Center. Even at stage 0, if the cancer is dispersed, a mastectomy is the standard of care. For patients with localized DCIS, breast-conserving lumpectomy surgery is recommended, typically followed by radiation. 

The surgical solution has long been the standard of care for DCIS. But Kruper along with fellow physician-scientists across the U.S. are aiming to change that with an innovative multicenter clinical trial called RECAST.

“The thought is: Are we overtreating ductal carcinoma in situ? Which patients with ductal carcinoma in situ can we offer something else to, other than surgery? Do we have other options for them?” said Kruper, who serves as principal investigator for the RECAST trial at Moffitt.

Exploring Treatments Beyond Surgery

The RECAST trial is open to women who have been diagnosed with low- or intermediate-risk hormone-positive DCIS. This means the body’s natural hormones are fueling the cancer cells. Participants are randomly assigned to one of four different estrogen-blocking therapies that show promise in other areas of cancer treatment:   

• Tamoxifen (for premenopausal women) or anastrozole (for post-menopausal women): These treatments are currently used post-surgery for patients with hormone-positive DCIS to prevent recurrence.
• Endoxifen: This more potent derivative of tamoxifen is already being investigated as a potential treatment for patients with estrogen receptor-positive metastatic breast cancer.
• Elacestrant: This medication, known as a selective estrogen receptor degrader, has been approved by the U.S. Food and Drug Administration to treat certain types of metastatic disease.
• Testosterone and anastrozole: This therapy, which is delivered via pellets under the skin, aims to block the conversion of testosterone to estrogen within the body.

Since the phase 2 trial launched at Moffitt in November 2025, Kruper has seen many women express interest in the nonsurgical approach.

“What’s great about this trial is it suits a lot of women. Some women state: ‘I’ve got a lot going on. I’ve got to take care of an aging parent. My daughter has a wedding coming up. I don’t want surgery. Is there a way that we can delay this?’” she explained. “Or some women really don’t ever want surgery.” 

Participants in the trial are monitored closely to document the effectiveness of the treatment. After three months on the trial therapy, participants receive an MRI. For those who are stable or show improvement, they can continue the treatment with another MRI at six months.

“That’s when we really start to see a lot of the improvements,” Kruper said. “For some people, everything goes away on imaging. So at month 6, the patients have a choice. They can either stay on the therapy, go off the therapy or decide that they want surgery.”

For those who choose to stay on the therapy or go off it but avoid surgery, they are monitored again with a follow-up MRI at the 12-month mark.

Hope on the Horizon

Across the United States, 28 institutions are enrolling patients in the RECAST trial, which is spearheaded by the nonprofit consortium Quantum Leap Healthcare Collaborative. Moffitt is the only site in Florida enrolling patients.

Kruper attributes that to Moffitt’s expertise in clinical trials.

“Our clinical trials office here at Moffitt is really amazing,” she said. “To run a clinical trial takes so much coordination and constant monitoring. You’re monitoring the patient for their side effects, so the clinical trial coordinators call in and check in with them. The patients are seen by a surgeon and a medical oncologist. The radiologists here are trained on how to read the enhanced MRIs for this trial. Most people don’t see all the work that goes on behind the scenes and how many people are involved in these clinical trials.”

To run a clinical trial takes so much coordination and constant monitoring. ... Most people don’t see all the work that goes on behind the scenes and how many people are involved in these clinical trials.

Laura Kruper, MD

Ultimately, with the RECAST trial, Kruper sees hope on the horizon for women who want to avoid surgery after a DCIS diagnosis.

“They always say: It’s about giving the right drug to the right patient at the right time. Right now, the standards are tamoxifen and anastrozole, and those are usually given after someone has had surgery to help prevent breast cancer from coming back. But can we flip it around and see which patients ultimately might not need surgery at all?” she pointed out. “It’s really trying to just push the frontier to have an arsenal of other options that we offer.”