Triple-negative breast cancer clinical trial allies with community oncologists

Triple-negative breast cancer (TNBC) is an aggressive disease that makes up roughly 15% to 20% of breast cancer diagnoses. Standard chemotherapy works for about half of these patients. But there is a significant need for personalized options to improve outcomes for all patients.

Through the Breast Cancer Moon Shot®, MD Anderson is conducting an innovative clinical trial, called ARTEMIS, to develop personalized therapy approaches for patients who are receiving neoadjuvant (pre-surgical) therapy for triple-negative breast cancer. The clinical trial’s unique design allows women to receive the first phase of neoadjuvant therapy in their local communities, through close collaboration between MD Anderson and community oncologists.

Stacy Moulder, M.D., professor of Breast Medical Oncology and co-leader of the Breast Cancer Moon Shot, spoke with Cancer Frontline about the importance of collaborating with community physicians to advance new breast cancer treatment options for patients with TNBC.

What are the goals of the ARTEMIS clinical trial?

We want to personalize therapy for triple-negative breast cancer. Half of TNBC patients have really good outcomes – complete responses or near-complete responses with standard chemotherapies.

We want to be able to identify those patients and give them standard therapies. At the same time, we want to focus on patients with chemotherapy-resistant disease to select an appropriate targeted therapy, based on molecular profiling in those patients.

At the start, all of our patients participating in this clinical trial will receive Adriamycin cyclophosphamide (AC) chemotherapy, and we want our patients to be in the best environment to receive that treatment. If they’re receiving standard chemotherapy, there’s really no reason that can’t be done closer to home.

After this initial chemotherapy, we assess how patients are responding. Those with tumors that have not substantially shrunk are offered therapy on clinical trials as their second phase of treatment. Patients who have adequate response are referred back to their local physicians to continue standard therapy as the second phase of treatment. That’s why it’s critical for us to partner with physicians outside of MD Anderson to provide the best options for patients.

How do you work with outside oncologists on a clinical trial like this?

We really want to make it a seamless and easy process so we can provide the best treatment option for the patient.

We have a rapid referral program to speed the process as much as possible, because we understand patients don’t want to be delayed any longer than necessary. We have available slots for imaging, biopsy and oncology, with a goal of scheduling a patient within 72 hours.

When a patient comes to MD Anderson, we arrange to have the clinic visit and necessary imaging and biopsies set up.  That way, if a patient is interested in participating in the clinical trial, we can get those taken care of quickly.

The patient can then go back to their local oncologist to start chemotherapy, and then they’ll return to MD Anderson for their assessments for response. We offer state-of-the-art imaging to assess response, and the clinical trial images patients more frequently than would typically be done as standard of care.

Patients who are doing well will continue standard therapy through their local oncologists. Patients with diminished response to therapy or disease progression will be offered an opportunity to participate in a different clinical trial at MD Anderson, based on the molecular profiling of their disease.

How does this unique clinical trial setup benefit TNBC patients?

If they’re getting chemotherapy closer to home, that means they don’t have to travel here for treatment, especially when they may not be feeling great due to side effects of treatment. They’re also around their support network, which can be very important for our patients. There are also the financial considerations of not having to travel and spend time away from home.

Many of our patients travel quite a distance to be treated at MD Anderson. If the patient has resistant disease and needs a clinical trial, then it's really worth those expenses. But if they're receiving standard of care treatment, we really don't want them to have any extra burdens because of their therapy.

What about benefits for outside physicians?

What the ARTEMIS trial platform does is actually profile the triple-negative breast cancer. When we complete this molecular profiling, we add it to the patient’s chart, so their referring physician will have access to that.

It also means that the physicians have more therapy options for their patients. Our clinical trial portfolio includes therapeutic strategies in combination with paclitaxel to target a variety of resistant tumor types. These strategies include immunotherapy and targeted therapies such as blockade of PI3Kinase, androgen receptor or EGFR.

Importantly, our trials are not randomized, so there is no placebo. All patients receive an active study drug. We all know that chemotherapy-resistant triple-negative breast cancer is a bad disease. Most patients will relapse and die from metastatic disease. But this clinical trial gives community physicians more options for treating their patients, especially those at very high risk.

How should interested physicians contact your team?

Email us at TNBC-NOW@mdanderson.org.