For Access To Breast Cancel Clinical Trials, Few Places Equal Marin General Hospital's Marin Cancer Institute

GREENBRAE, CA — For more than 25 years, North Bay breast cancer patients have enjoyed extraordinary access to clinical trials through Marin General Hospital's Marin Cancer Institute (MCI). In the past quarter century, they have participated in 75 clinical trials for breast cancer alone, benefitting from cutting-edge medications and treatment protocols that have reduced mortality and enhanced quality of life for patients.

"We have a national reputation as a community-based research program that competes well with much larger academic institutions," says Dr. Peter D. Eisenberg, an MCI oncologist who began building relationships with the nation's top cancer centers and researchers more than three decades ago. "Some of the studies in which we have participated focused on treatments to cure early breast cancer or prolong lives. Others aimed to improve the quality of life of women with more advanced disease. We've been involved on every front of cancer research."

Eisenberg's quest to find clinical trials for his patients began shortly after he started his practice in 1978. A young woman was diagnosed with an extremely aggressive breast cancer, and standard therapy seemed ineffective. He called an acquaintance at the University of Pittsburgh, the now legendary Dr. Bernard Fisher, who was doing National Cancer Institute (NCI) -funded breast cancer research. Fisher invited Eisenberg to join him as a member of the National Surgical Adjuvant Breast and Bowel Project (NSABP) and enter the patient. Marin General Hospital and Eisenberg's practice became part of only a handful of community practices provided with an opportunity to participate in NCI-funded research studies.

By the mid-'80s Eisenberg and his colleagues were enrolling their patients in numerous studies, sometimes funded by pharmaceutical companies. The first exciting Pharma trial was for Taxotere; a promising investigational drug for breast and lung cancer. In the early '90s, there were only four places in the country one could obtain Taxotere: Sloan Kettering, MD Anderson, the University of Texas in San Antonio, and at the MCI in Greenbrae. The Institute gained respect and visibility and was soon busy enrolling patients in other trials.

"Almost all drugs approved for breast cancer in the past 20 years were studied here and provided to our patients at the Marin Cancer Institute before they were commercially available," says Eisenberg. Many were game-changing medications shown to improve cure and survival rates, including Herceptin, Taxotere, XelodaExemestaneArimidex, and Navelbine.

"We also have studied a number of drugs that, while they do not kill breast cancer cells, improve one's quality of life or reduce the toxicities of treatment," says Eisenberg. "These include bisphosphonates such as Aredia and Zometa - which have been proven to decrease the incidence of serious fractures and the need for surgery and radiation in women with advanced breast cancer. We also studied practically every new anti-nausea medicine available. These have significantly improved the tolerability of chemotherapy and the quality of life for our patients."

"Peter uses his network of friends and acquaintances he's made as the founder of the Association of Northern California Oncologists and as a board member of the American Society of Clinical Oncology, to benefit our patients," says oncologist Dr. Bobbie Head, Eisenberg's colleague at the Marin Cancer Institute. "He's our clinical trial champion - if we find a trial that might benefit a patient, he'll be on the phone immediately, working to get that patient enrolled."

A Chance to Raise Their Odds

Patients from all over the Bay Area, including those from the major academic medical centers, call him, referred by their doctors to promising MCI trials.

One such patient is Sebastopol resident Sue Pike. When she was diagnosed with Stage II, Grade 3 breast cancer, her doctor referred her to MCI instead of a local center in Santa Rosa. Dr. Jennifer Lucas was her oncologist, and the treatment included chemotherapy and Herceptin (an agent that disrupts cancer cells' ability to reproduce) followed by a mastectomy. After her treatment, Lucas offered Pike an opportunity to participate in a clinical trial testing a new pill form of Herceptin that scientists hope can prevent cancer recurrence. Despite its sometimes unpleasant side effects, Pike jumped at the chance.

"Dr. Lucas told me I had about a 90 percent chance of being cured," Pike says. "If doing this trial for a year had the possibility to raise my odds even higher, I was all for it. And whether or not it worked to prevent cancer recurrence, I felt that I might potentially be helping other women through this research."

Four years later, Pike is still cancer free and leads a healthy, active life. The trial in which she participated is still ongoing, but results to date are promising. "Whether it ultimately proves successful or not, I would do it all again," she says.

Denise Swett, associate vice president at Foothill College in Los Altos Hills, was 48 when she was diagnosed with breast cancer during a regular mammogram. After a lumpectomy, the San Rafael resident underwent treatment consisting of AC chemotherapy, Taxotere, surgery to remove her lymph nodes and radiation, all at MCI. The final step might have been Tamoxifen, but Head strongly recommended she instead enroll in a clinical trial for a new drug, Arimidex, that had shown excellent results in European trials.

"Because it was Bobbie, I just jumped at the chance," Swett says. "And from the start, I had great results." Swett was on Arimidex for five years.

"There were side effects - hot flashes and weight gain - but I'm seven years out now, and when I hear the word 'cancer' I think, been there, done that," Swett says. "I feel so fortunate - Marin Cancer Institute gives you so many amazing opportunities to try state-of-the-art treatments. I think people would be crazy to go anywhere else."

A little over a year ago, Marian Caldwell came to the same conclusion. After finding a lump in her breast, she went in for a mammogram, followed by a sonogram. It not only revealed the breast lump but something in her lymph nodes. After a biopsy, the 41-year-old mother of two was given a diagnosis of Stage 2 breast cancer.

Caldwell was referred to Marin Cancer Institute for treatment. She met with Lucas and then was referred to a specialist at UCSF for further evaluation. The PET scan the specialist ordered showed Caldwell's disease was more serious than they first thought.

Back at MCI, she and Lucas discussed her options. The recommended treatment was six four-week cycles (later extended to 10) of Avastin, a relatively new "antiangiogenic" drug that restricts blood vessel growth in tumors, paired with a standard chemotherapy agent, Taxol. Prior studies with Avastin had shown remarkable promise in treatment of metastatic breast cancer. But the combination of the two drugs also had some potentially difficult side effects.

Lucas told Caldwell there was another option; enter a Phase III clinical trial that might randomly assign Caldwell to one of two other drugs (Abraxane or Ixempra) paired with Avastin. Or she might end up within the Taxol/Avastin control group. Caldwell would get Avastin regardless of which group she was assigned.

Overwhelmed with doubt at first, Caldwell sought a second opinion at UCSF. The oncologist there recommended the same clinical trial. Hearing that, she made her decision; she would enter the clinical trial through MCI. Treatment began Oct. 6th, 2010, and finished on July 5th, 2011.

"What I realized is that being in a clinical trial is actually advantageous," Caldwell says. "You get more monitoring, more tests and more attention, and if they don't think things are going well they will stop the treatment immediately."

On one level, things did go well. The first CT scan in November showed a 40 percent reduction in her tumors. In January and March, the scans showed the tumors continuing to shrink. By May, she was in complete remission. PET scans, performed as an additional check of cancer activity, confirmed her remarkable progress.

But it came at a price. The chemotherapy agent (which she later learned was Taxol) caused neuropathy so extreme it felt like "thorns eating at my hands and feet," she says. Lucas was worried, but Caldwell felt she could manage it - and she had the incentive of those shrinking tumors. By July, they both felt the drugs had done their work, and stopped the treatment. Another PET-CT scan in September showed the tumors had shrunk even more. This month, Caldwell will undergo surgery to remove the primary tumor.

"Even though I ended up with the same drugs I would have had without the clinical trial, I felt good knowing that I was helping other patients by participating," Caldwell says. "And the trial offered the chance for the best follow-up, monitoring and screening. If I were offered another clinical trial, I would jump at it. My message for other women is to always have hope. I am incredibly lucky that MCI is there - I applaud them for being willing to try to get patients into trials."

Making a Lasting Impact on Cancer Treatment
If anything, MCI's involvement in trials is accelerating. Recently, it has been participating in two exciting and closely watched Phase I trials. In one,Oncomed's anti-cancer stem cell antibody is being investigated. In the other trial, BIND Bioscience's nano-particle formulation of the successful cancer drug Taxotere is being tested as to whether the new formulation can achieve better therapeutic effectiveness with reduced side effects.

Both trials break new ground, testing untried mechanisms to kill cancer cells. Eisenberg gets excited about that. "Whether or not they will be effective is the question," he says, "But the patients in these trials have often exhausted other treatment options for their diseases. This gives them another chance."

"It's exciting to know that we're making a lasting impact on the science of cancer treatment," says Eisenberg, "More important, though, is the fact that we're expanding the options for our patients."