One of the five primary goals SWOG identified in its 2019 strategic plan was to "develop novel approaches to strategic partnerships." SWOG Clinical Trials Partnerships (SWOG CTP) is a key strategy for meeting this goal.

CTP-run studies are non-federal trials, with special attention to those that focus on platform studies and comprehensive pipelines. Such pipelines naturally cross multiple disease areas, so in identifying the best leader for this initiative, I wanted someone with a strong clinical trials background, who could move expertly from disease to disease. I wanted someone who could build a program from the ground up.

I found the ideal candidate in Dr. Kathy Albain, who now has been SWOG’s vice chair for Clinical Trials Partnerships since 2019. Dr. Albain, professor of medicine and the Huizenga Family Endowed Chair in Oncology Research at Loyola University Chicago Stritch School of Medicine, has been a SWOG member – and a particularly active one – for almost her entire professional career.

Dr. Albain is remarkable for her combination of breadth and depth in disease areas, having led major trials in breast cancer and lung cancer and having made important contributions to the study of cancer in special populations and survivorship. Her start-up experience includes founding and chairing SWOG’s Committee on Special Populations in the 1990s, which incorporated SWOG’s first organized group of patient advocates. This committee morphed into the Cancer Survivorship Committee in 2008, which Dr. Albain continued to co-chair for several years. She also remains a member of six SWOG research committees (breast, lung, cancer care delivery, survivorship, early therapeutics and rare cancers, and symptom control and quality of life).

A clinical trialist through and through, she led nine SWOG studies and contributed in major ways to dozens of others. The one that has probably reverberated most loudly recently is the landmark S8814 trial, which found that for postmenopausal women with node-positive, estrogen receptor–positive breast cancer, getting tamoxifen after CAF (cyclophosphamide, Adriamycin, and 5-fluorouracil) was better than getting the two treatments simultaneously.  

S8814 has proven to be a gift that keeps on giving. Additional findings from it showed that the 21-gene recurrence score has prognostic and predictive value for both chemotherapy and radiation therapy benefit in these node-positive patients. And SWOG’s RxPONDER trial, which reported final results to considerable fanfare last December, validated the S8814 findings that among these patients, those with a low recurrence score and up to three positive lymph nodes can forego chemotherapy and be treated with hormone therapy alone.

At the time the S8814 results were published, Dr. Albain says, "a lot of experts thought that no one with node-positive disease should avoid chemotherapy. So to have the RxPONDER trial prove it’s true in postmenopausal women is a highlight  of my career!"

She emphasizes that the ability to collaborate in a study sequence like this – treatment protocol to translational medicine research to phase III validation – is why she has embraced the opportunities in SWOG over the years and is what excites her about the potential of SWOG CTP.

In leading that platform, Dr. Albain is focusing on the organization’s new Preferred Partnership Program (PPP), which develops long-term strategic alliances with companies built on drug pipeline access or complex multi-arm platform trials. These are rigorous, scientifically relevant, and fully industry-supported studies. SWOG CTP still manages committee-initiated, industry-funded single studies, as did its forerunner, the Clinical Trials Initiative, but its primary focus is PPP alliances.

"CTP’s PPP is an exciting new direction for SWOG that builds on all of SWOG’s strengths," says Dr. Albain. "It expands our therapeutic horizons beyond what’s available to be done on federally funded trials without competing with them. In that way it allows us to offer more trials to more patients at our sites. It will also offer SWOG’s junior investigators chances to be involved in arms of platform and pipeline-type trials."

Under Dr. Albain’s leadership, SWOG CTP has just this week signed its first preferred partnership master agreement, formalizing a partnership with Novartis that will test agents from throughout the company’s deep pipeline across multiple disease types.  "CTP is also in advanced discussions with three other potential partners with exciting platform studies," she says, "with guidance from the CTP Executive Committee, CTP Scientific Advisory Board, and SWOG committee chairs and with tireless effort by our administrative team."

In brief, great things are brewing at CTP under Dr. Albain, and I will have plenty to say in future Front Line postings about all of them!

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Jul 9, 2021
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