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

Experimental Therapy Aids Patient with Triple-Negative Breast Cancer

October 2016

Contributed by Douglas Yee, MD

Breast cancers that do not express the most successful treatment targets—estrogen, progesterone, and HER2 receptors—the so called “triple-negative” breast cancer, present unique treatment challenges. Novel trial therapies, however, have shown promise for patients with this diagnosis. In this case study, multidisciplinary care and access to an innovative clinical drug trial provide a new option for a patient with triple-negative breast cancer.


A 41-year old woman presenting with a breast mass was referred by her primary physician to University of Minnesota Health Cancer Care specialists for further evaluation. She received a mammogram and an ultrasound, which showed a 3 cm mass in her left breast. The mass was biopsied and was found to be a triple-negative invasive ductal breast cancer. The radiologist referred her to M Health medical oncology and surgical oncology clinics for further evaluation.


Triple-negative breast cancer has a high risk of recurrence, a risk that can be reduced by chemotherapy. The patient was presented with the treatment options of immediate surgery followed by chemotherapy or chemotherapy prior to surgery. She was also eligible for a clinical trial (I-SPY2) to determine if a novel drug therapy added to the standard-of-care chemotherapy improved responses.

The patient agreed to enroll in the I-SPY 2 clinical trial offered through the Masonic Cancer Center, University of Minnesota, one of 16 sites participating in the new approach to clinical trials.

The patient was among 115 women in the multisite trial’s treatment group who received the experimental drug veliparib in combination with carboplatin and standard chemotherapy. Seventy-eight participants in the control group received standard chemotherapy. Each patient received additional research biopsies and MRIs to evaluate tumor response.

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— A novel drug combined with standard-of-care chemotherapy provides a successful outcome for a clinical trial participant. The drug therapy is being further evaluated in a phase III trial.

Even after 3 weeks of therapy, the MRI demonstrated response. At 12 and 24 weeks of treatment, imaging of the patient showed no evidence of breast cancer. The patient then underwent surgery to remove any residual cancer. The procedure confirmed that she had achieved a pathologic complete response with no evidence of tumor in the breast or sentinel lymph node biopsy. The patient preferred a bilateral mastectomy over breast conserving surgery.

The patient’s breast cancer did not require postsurgery therapy, and she is now cancer-free. She was provided a survivorship care plan that outlines all treatments she received, and she continues to be monitored for potential late effects of chemotherapy.


Of those participating in the multisite clinical trial, 51% of patients with triple-negative breast cancer receiving veliparib in combination with carboplatin and chemotherapy achieved an estimated pathologic complete response compared to 26% of those receiving standard chemotherapy.1 Given the encouraging initial findings, the drug therapy veliparib and carboplatin is currently being further evaluated in a small phase III clinical trial in triple-negative breast cancer.

This patient directly benefitted from the experimental therapy and from this clinical trial’s unique approach. When the trial findings, collected across study sites, suggest that an experimental drug demonstrates effectiveness, additional suitable candidates are assigned to the treatment group. The adaptive approach expedites further study of a promising drug therapy. (See “Speeding Development of Breast Cancer Therapies”). In this instance, it gave the patient access to effective treatment.


  1. 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.
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