Santa Clarita Valley Hospital Radiation Oncologists Seek Ideal Candidates for Clinical Trial: Women 45 and Older with Breast Implants and Stage 1 Diagnosis
A team of breast cancer specialists at Henry Mayo Newhall Memorial Hospital is ready to begin an innovative clinical trial testing new treatment of breast cancer for women who have breast implants — as soon as the doctors leading the study find the right candidates.
About 40 percent of breast cancer patients with prosthetic implants suffer breast disfigurement after full-breast radiation treatment, according to Gregory Senofsky, MD, FACS and head of the Sheila R. Veloz Breast Center at Henry Mayo. He has seen “hundreds” of such cases in his 14 years at the Santa Clarita Valley hospital.
Dubbed FASTER (Feasibility of Accelerated StereoTactic Radiation Therapy), the new clinical trial involves targeting just the cancer, not the entire breast, resulting in less disfigurement for women with implants. Until now, they have not been able to get this kind of partial breast radiation therapy.
“When patients are diagnosed with a small breast cancer tumor, and they have breast implants, it can be very difficult to treat without harming the implants,” said Donna Ferguson, RN and director of Henry Mayo’s outpatient services, including the Sheila R. Veloz Breast Center. “This clinical trial is targeted radiation therapy at the tumor site without the damaging the skin or implant beneath it.”
A FASTER Way to Treat Breast Cancer for Women with Implants
Like Senofsky, other Henry Mayo oncologists and physicians involved in the trial have seen breast cancer patients with breast implants forced to remove the implants prior to radiation therapy, or risk disfiguring contractures or dimpling of the skin.
“That can be painful and also look very poor cosmetically,” Ferguson said. “So (the doctors) determined if they were able to target the radiation therapy right at the tumor site and not do a full breast radiation, it would prevent that damage to the skin and implant.”
In clinical terms, Senofsky said, the trial treatment protocol “is a partial accelerated stereotactic external beam approach given as 10 treatments over the course of five days, using intensity-modulated radiotherapy (IMRT).”
Senofsky said the FASTER clinical trial seeks to “adequately treat these patients oncologically and avoid the 40 percent or more risk of capsular contracture that occurs with whole breast radiation therapy in patients with breast implants, often requiring more extensive surgery such as mastectomy and free-flap reconstruction.
“Furthermore, should any of these patients develop a second breast cancer in their future, they will not be relegated to mastectomy and reconstruction, which we know is more challenging and anxiety-provoking to these patients,” he said. “Women will want to do this because it’ll potentially save them having to have the implant removed at a later date.”
Senofsky and colleagues Robert Zimmerman, MD, Henry Mayo’s head of radiation oncology, and Sumita Bhatia, MD, also a radiation oncologist at the hospital, came up with the idea for the clinical trial. Henry Mayo’s Institutional Review Board approved it.
“It’s a home-grown idea,” Senofsky said.
The FASTER team then connected with peers at Vantage Oncology, a nationwide radiation oncology network headquartered in Los Angeles.
“Women with breast implants have not been able to get partial breast radiation therapy to date because the implant prevents that method from working,” Senofsky said. “So, we came up with this alternate method using the external beam approach, using IMRT.
“Our radiation oncologists at Vantage figured out how to do this using the implant as part of the staging process for delivering the radiation therapy,” he said.
Henry Mayo Wants FASTER Breast Cancer Patients 45 and Older
Now, the Henry Mayo FASTER team just needs FASTER patients to participate in the trial.
“We’re looking for candidates,” Senofsky said, describing the ideal participant as “a woman older than 45 who has breast implants and an early stage cancer, Stage 1, with no lymphovascular invasion.” The patient must otherwise be cancer-free, with no history of radiation or chemotherapy, or previous capsular contracture.
The FASTER clinical trial is open to women anywhere in the Santa Clarita Valley and the greater Los Angeles area who meet the qualifying criteria.
“Since a very unique population is needed for this clinical trial, we are anxious to get the word out,” Ferguson said.
“We’d like women who have breast implants who are diagnosed with early stage breast cancer to know we’re providing this treatment, and we’re anxious to get the results after performing the clinical trial on an number of patients,” she said.
“We think it’s going to be highly successful,” Senofsky said. If the study does indeed produce positive results reported to Vantage, “then other (oncologists) will start trying it and doing it around the world.”
Call 661-253-8822 to make a FASTER appointment or visit www.henrymayo.com for more information.
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Source: Santa Clarita News