Two studies tackle early-stage breast cancer

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Study subject: Ingalls oncologist Dr. Mark Kozloff suggested patient Laura Bojanski, who was diagnosed with HER2-positive breast cancer, participate in a study of the the investigational drug Pertuzumab. | Supplied photo

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Two groundbreaking breast cancer placebo-controlled clinical trials are now available through Ingalls Cancer Care and are targeted for women with early-stage breast cancer.

Laura Bojanski of Lowell, Ind., is one of them.

“The study is like added security for me,” she explained.

Bojanski, 47, was diagnosed with aggressive HER-2 positive breast cancer in March 2012. A routine mammogram showed a suspicious mass on her right breast. A follow-up MRI showed questionable spots on her left breast too, so Bojanski made the difficult decision to have a double mastectomy with immediate reconstructive surgery at Ingalls the following month.

“It had spread to an area too large for a lumpectomy,” she explained.

When her oncologist Mark Kozloff, M.D., discussed treatment options, he mentioned the APHINITY study, which is looking at whether or not the investigational drug Pertuzumab, given in conjunction with chemotherapy and Herceptin, could be a potential treatment option for patients with HER2-positive breast cancer. The study is taking place at 700 sites worldwide and is of global significance following the results from a previous positive trial of Pertuzumab in metastatic breast cancer patients.

Patients who have been recently diagnosed with HER2-positive primary invasive breast cancer and who have also had surgery for their primary tumor are eligible to participate in the APHINITY trial at Ingalls.

“Dr. Kozloff broached the idea of a clinical study before I could even ask about it,” Bojanski added. “This was all so new to me, but I quickly realized it was a good thing.”

Bojanski began both chemotherapy and the clinical trial in June and will continue on the trial for a full year, though her last chemotherapy treatment ended in October.

“There are some side-effects, but I’m handling them very well,” she added. “I’ve got an extremely positive attitude, and I’ve had it since day one. Participating in the APHINITY study gives me added confidence that I’m going to beat this!”

A second study

The MA-32 Study at Ingalls involves the diabetes medication Metformin (Glucophage) for early-stage breast cancer patients who have already undergone surgery and subsequent breast cancer treatment, including chemotherapy and/or radiation. The study is looking at whether Metformin can decrease or affect the ability of breast cancer cells to grow and if it will work with other therapies to keep cancer from recurring.

Winni Harrison, 68, of Chicago, enrolled in the Metformin study at Ingalls last June.

“If the study I’m doing is going to help other women in the future, that’s great,” Harrison, a survivor of both cervical and skin cancers, said. “Giving up is not an option for me. Those things that happen to us in life are going to happen. Staying positive helps us to get through it.”

Following a screening to determine eligibility, treatment may last up to five years.

“Non-diabetic women younger than 75 who have been diagnosed with early-stage breast cancer in the last 12 months are eligible for the study,” explains James Wallace, M.D., hematologist/oncologist on staff at Ingalls Memorial Hospital. “A woman would be randomly assigned Metformin or a placebo. A patient can still be on standard treatment — like radiation — while participating in the trial.”

Although Metformin is approved by the FDA for the treatment of diabetes, its use in breast cancer is considered investigational.

“Another earlier study showed that diabetics with breast cancer responded more favorably to breast cancer therapies given before surgery,” he added. “The researchers think Metformin might act against breast cancer by working directly on the cancer cells — that by lowering insulin levels you decrease enzymes in the cell, which, in turn, decrease growth and proliferation of the breast cancer cells. That’s where almost all the research is right now ... finding something abnormal about the cancer cells, then target that abnormality to increase benefits and decrease the toxicity.”

More information about these and other cancer research studies at Ingalls is at 708.915.HOPE (4673).

Provided by Ingalls Health System