Seeking less aggressive breast cancer treatment, Anne Arundel Medical Center takes part in clinical trial

Surgeons at Anne Arundel Medical Center’s Rebecca Fortney Breast Center are involved in a new clinical trial aimed at using less aggressive treatment for some forms of breast cancer.

The COMET study — Comparison of Operative to Monitoring Endocrine Therapy — is trying to determine if doctors can eliminate some of the treatments for women discovered to have low risk, Stage 0 breast cancer, usually during a mammogram screening years before a lump forms. Women in the study have ductal carcinoma in situ, microcalcifications that can be abnormal or benign cancer cells in the milk ducts of a woman’s breasts.

“This study is very exciting, the next big frontier in breast cancer treatment with no surgery,” said Dr. Wen Liang, a practicing breast surgeon since 2000 and at AAMC for the past eight years. “We’re trying to change our care and perception of care with less aggressive treatment.”

Currently, 12 women are actively involved in the study; five of them are patients at AAMC since March. The Annapolis hospital is the only cancer center in Washington, D.C.-Maryland-Virginia area involved in the study, which will eventually spread to 100 cancer centers across the United States. The closest neighboring trial sites are in Pittsburgh, Pennsylvania, and at Duke University in Durham, North Carolina, where Dr. Shelley Hwang is the principal investigator.

DCIS is 99 percent curable because the cancer has not broken out of the milk ducts into the fat of the breast. More than 50,000 women are diagnosed with this cancer each year and research has shown that the 70 percent to 80 percent of DCIS diagnoses might never become invasive breast cancer.

“Many women die with DCIS than of DCIS,” Liang said. “Treatment is surgery — a lumpectomy — followed by radiation and five to 10 years of endocrine medications. Surgery can lead to issues of chronic seroma, a fluid buildup; or scarring. Radiation usually consists of 20 treatments over a four-week period.”

To determine if doctors can eliminate some treatments at this stage, the investigators will compare two groups of women, ages 40 or older, diagnosed with low-risk DCIS. The participants will be randomly assigned to one of two groups. One group will have breast surgery, with possible radiation and/or endocrine therapy. The second group will undergo active surveillance.

Doctors will closely monitor these women with regular follow-up exams and tests for 10 years. They might also opt to treat some of this group’s participants with therapy if needed. Eventually, the researchers are hoping to enroll 1,200 women in the study.

The COMET trial is sponsored by the Alliance Foundation Trials LLC, of Boston, in conjunction with Washington-based Patient-Centered Research Institute, which is providing the funding for the study.

“We’re trying, overall, to do less aggressive treatment for this group of patients as ‘less is more,’ ” Liang said of the surgeon-run trial.

Patients in the trial will undergo a mammogram twice a year for five years, longer if needed. The radiation of one mammogram is equivalent to the exposure to radiation in a cross-country flight at high altitude, Liang said.

“It’s the only way we can watch to assess the micro-calcifications,” she said.

Liang urges women who have been diagnosed with Stage 0 breast cancer to discuss the study and its parameters with their own doctor and breast surgeon.

To be eligible for COMET, women must:

  • Have low-risk DCIS
  • Be at least 40 years old
  • Have no history of breast cancer or prior treatment for DCIS

A woman must register for the COMET trial within 90 days of her cancer diagnosis of Grade 1 or 2, Stage 0 breast cancer. She must also be hormone receptor positive.

“The patients already enrolled in this program see this as an opportunity to give back and help others,” Liang said.

Laura Martino, a clinical research coordinator at the Fortney Breast Center, screens patients for eligibility in the COMET study. She notifies Liang or the other AAMC surgeons if a patient is interested in hearing more.

“I go through the details of the study with them and if they go forward, I facilitate the study requirements with them,” Martino said.

Of the five patients currently in the study, Martino researched 15 patients. Ten were either ineligible or they declined to participate.

“COMET is awesome,” Martino said. “We’re happy to have it here.”

If you are interested in the study, email Martino at lmartino@aahs.org, call 443-481-5949 or visit www.dcisoptions.org.

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