Clinician-to-Clinician Update Clinician-to-Clinician Update

Speeding the Development of Breast Cancer Therapies

October 2016

Breast cancer is the most frequently diagnosed cancer in women in the United States and ranks second—after lung cancer—as a cause of cancer death in women. Because of improved early detection and treatment, breast cancer death rates declined by 36% from 1989 to 2012. However, an estimated 40,890 deaths from breast cancer (40,450 women, 440 men) are expected in 2016.1

Recent research efforts have focused on identifying and expediting the study of therapies targeted to specific cancers. One new clinical trial model, called I-SPY 2 TRIAL2, draws on a database of multisite patient data and crossinstitutional collaborations to speed the testing of novel therapies for patients with recently diagnosed, advanced local breast cancer. I-SPY 2 TRIAL allows all trial treatment data to be collected, verified, and shared in real-time among academic, medical industry, and regulatory partners. In a traditional drug trial, researchers wait years to learn whether an experimental drug is effective. The I-SPY 2 TRIAL model allows for the evaluation of results after 24 weeks of treatment with a new therapy. University of Minnesota Health is one of only 16 sites around the United States and Canada participating in the I-SPY 2 TRIAL program.

In the I-SPY 2 trial, each patient’s tumor is biopsied and evaluated against 10 distinct cancer biomarkers, or “signatures,” to precisely classify the tumor, and patients are grouped and followed accordingly. Within the clinical trial, a treatment group receives standard chemotherapy plus an investigational drug targeted for a specific tumor subtype, while a control group receives standard-of-care chemotherapy alone.3

— Medical oncologist Douglas Yee, MD, leads University of Minnesota Health Cancer Care participation in the I-SPY 2 TRIAL.

After 24 weeks of treatment, patients undergo surgical removal of any residual cancer in breast tissue and lymph nodes. If no cancer is found, the patient is said to have a pathologic complete response, which is the primary endpoint of I-SPY 2 and is considered a marker of longer-term survival. Patients also receive 4 MRI breast exams as part of the study.

The assessment of response by MRI and surgery helps to rapidly identify active drugs and eliminate drugs that appear to offer no benefit over standard-of-care chemotherapy. These findings are entered in the I-SPY 2 database and are monitored by a central biostatistical team. As the trial progresses, the patient with a specific signature may be assigned to a specific drug due to previous success in that signature. The trial adapts over time. This adaptive approach could allow for greater flexibility of treatment and faster completion of clinical trials4, making more efficient use of clinical resources.5

The drug, neratinib, is one of the first agents to show effectiveness in an I-SPY 2 clinical trial. Another experimental drug veliparib with carboplatin when given in combination therapy has shown promise in the treatment of those with a triple-negative breast cancer diagnosis. In a phase II trial, 51% of women receiving the novel drug achieved a complete response as compared to a 26% rate in the control group receiving standard care.6 Veliparib added to carboplatin and paclitaxel is now being further evaluated in a phase III trial to confirm the I-SPY 2 results.


  1. American Cancer Society. Cancer Facts & Figures 2016. Atlanta: American Cancer Society; 2016.
  2. The trial model name stands for “Investigation of serial studies to predict your therapeutic response with imaging and molecular analysis.”
  3. I-SPY. Accessed August 31, 2016.
  4. Carey LA, Winer EP. I-SPY 2—Toward more rapid progress in breast cancer treatment. N Engl J Med. 2016;375(1):83-84. doi:10.1056/nejme1603691.
  5. Harrington D, Parmigiani G. I-SPY 2 — A glimpse of the future of Phase 2 drug development? N Engl J Med. 2016;375(1):7-9. doi:10.1056/nejmp1602256.
  6. Rugo HS, Olopade OI, Demichele A, et al. Adaptive randomization of veliparib–carboplatin treatment in breast cancer. N Engl J Med. 2016;375(1):23-34. doi:10.1056/nejmoa1513749.

When to refer

University of Minnesota Health Cancer Care specialists provide collaborative, multidisciplinary care and the latest evidence-based therapies. Our team includes surgical, radiation, and medical oncologists as well as pathologists, genetic counselors, rehabilitation therapists, and social workers. The Masonic Cancer Center, University of Minnesota, provides access to important clinical trials aimed at both prevention and treatment of breast cancer.

We work hard to keep you informed of your patients’ care by providing detailed reports, from diagnosis to treatment and follow-up. Our goal is to provide you with prompt service and communication for the patients that you refer to us.

Collaborative Care

Many of our patients do not live within the Twin Cities metropolitan area. To minimize travel difficulties and lost time from school or work for our patients, we are committed to partnering with the patient’s referring provider and other local providers. Some patients can be initially discussed over the phone in collaboration with the referring provider. We aim to expedite the process so that, in one trip to the Twin Cities, patients can be assessed and also complete surgery, if required. In many cases, care after discharge can also be provided locally.

Physician Outreach Program

The Cancer Care Outreach Program is designed to provide education and facilitate knowledge sharing between our team and the medical community. To schedule a physician meeting or to visit our facility, contact Melinda Tuma Arvold, System Manager, Outreach Services: 612-867-3411;

To view current clinical trials available through M Health providers, visit

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