Connecticut Breast Health Initiative

NEW HAVEN — Removing a small amount of extra tissue around a breast cancer tumor may keep a patient from having a recurrence of the cancer or of having to return to the operating table because not all of the malignant cells were removed in the first operation.

That’s the theory that’s being tested in a nationwide clinical trial sponsored by the Yale Cancer Center called SHAVE2. Dr. Anees Chagpar, assistant director of global oncology at the Yale School of Medicine and former director of the Breast Center, is the principal investigator.

Chagpar oversaw the first SHAVE trial at Yale, which involved 235 patients with stage 0 to stage 3 breast cancer who were given a partial mastectomy, also known as a lumpectomy. Some were given normal lumpectomies, while others had more tissue removed from around the tumor site, known as cavity shave margins.

“I was the biggest skeptic in SHAVE,” Chagpar said. “I had done this trial not to prove that cavity shave margins were superior. ... But now that we have those trial results from SHAVE, I am absolutely a believer in this technique and use it on all of my patients. I am absolutely convinced that it reduces positive margins and re-excision rates.”

Video https://www.nhregister.com/health/article/Yale-s-advance-in-breast-cancer-surgery-to-be-12604324.php#photo-15059749

The first study was a double-blind trial in which neither the patient nor the surgeon knew in advance whether the extra margin would be removed.

“We told surgeons, do your very best operation … and once you were finished doing your best operation and were ready to close, we had sealed envelopes in the operating room,” Chagpar said. Inside the envelope were instructions either to close the surgical site or to take an additional 3- to 5-millimeter margin from around the site before closing, “kind of what you’d take in a re-excision,” she said.

“This was really a landmark study because ... we found that by taking a little more tissue around the cavity, we could reduce positive margin rates by 50 percent and cut the need to go back to the operating room for re-excision in half,” Chagpar said.

“This was huge, and we found that this technique only took 10 minutes in the operating room. It did not result in any increased complications and the cosmetic results were equivalent in both groups.”

The results were presented to 37,000 oncologists in May 2015 at the annual meeting of the American Society of Clinical Oncologists in Chicago, Chagpar said. The study was published in the New England Journal of Medicine, accompanied by “a very flattering editorial.”

“The whole SHAVE hullabaloo ... was a remarkable time,” she said. “The news coverage of that trial was phenomenal. It was in the top percentile of all New England Journal articles in terms of ... social media.

“One of the questions that remained, however, was: Could this be reproduceable?” she said. “Could a general surgeon in rural Idaho do the same thing and get the same results?”

So SHAVE2 was designed, “a multicenter trial involving nine sites around the nation, all varying in terms of their location, practice setting, etc.,” Chagpar said. It will involve 400 patients at cancer centers in California, Florida, Michigan, North Carolina, Ohio, Pennsylvania, Rhode Island and Texas. They include “small private practice centers, big academic centers,” she said.

Chagpar said her enthusiasm is not shared by all breast cancer surgeons, “which is why we are doing SHAVE2. We couldn’t do SHAVE2 if everybody had automatically converted.

“When we set out to do the SHAVE2 trial … what was necessary was also to have a central command post to run the trial,” Chagpar said. Yale is the “central hub” for SHAVE2, randomizing patients, collecting and managing data and performing regulatory functions.

Chagpar’s work is being supported by a $100,000 grant from the David and Katie Burke Fund for Breast Cancer Research, founded by a former patient of Chagpar’s, which will underwrite oversight of the centers, and by a $50,000 grant from the Connecticut Breast Health Initiative that will help pay for a research associate’s salary.

“We’ve had to cobble together resources and have been very grateful for all the support that we’ve received,” Chagpar said.

The Connecticut Breast Health Initiative, based in New Britain, focuses on breast cancer research and education solely within the state and has raised more than $3.6 million for the cause. Its major fundraiser, the Race in the Park, which includes a 5K run, as well as shorter routes at Walnut Hill Park in New Britain, will be held May 12, said Kim Neurath, the race coordinator.

“We do fund those forward-thinking programs that have not yet qualified for federal funding,” Neurath said. “We are seed money for those research and education institutions and individuals who are working on breast cancer research.”

The race raised more than $500,000 in 2017, and the organization tries to award at least five grants a year, she said. This is its 15th year.

Joyce Bray, president of the nonprofit organization, said, “A lot of times we have more requests than we have money,” but that Chagpar’s proposal “was one of the best and we think there will be a good impact and end result.

“I just think she’s brilliant, very articulate and very dedicated,” Bray said of Chagpar. She said she believes the shave margin procedure “saves on insurance costs, saves on hospital costs, saves on emotional costs. It just makes sense.”

Chagpar is optimistic SHAVE2 will prove that the shave margin technique will become the standard in partial mastectomies for breast cancer. The first trial has already been adopted in places such as Brazil and South Korea and a clinical trial has been undertaken in Pakistan, she said. “I think that the initial SHAVE trial is really revolutionizing how breast cancer surgery is performed worldwide,” she said.

“But I think that the purpose of SHAVE2 is really to validate these findings. ... This will be the first multicenter random controlled trial to evaluate the efficacy of this technique across more practice settings nationwide.”

This story has been edited to correct the countries in which the SHAVE trial is being studied.

Contact Ed Stannard at edward.stannard@hearstmedia