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An expert shares information on a pair of noteworthy active trials in breast cancer that patients should be aware of.
For patients with triple-negative breast cancer, there are now several clinical trials examining what happens, treatment-wise, following the current standard of care, Dr. Yuan Yuan explained in an interview with CURE®.
In recent years, incorporating chemotherapy plus the immune checkpoint inhibitor Keytruda (pembrolizumab) has become the standard of care in the early-stage setting for patients with triple-negative breast cancer, said Yuan, a professor of medicine, director of Breast Oncology and medical director of Breast Cancer Research at Cedars-Sinai Medical Center in Los Angeles, as well as a health sciences clinical professor at the University of California, Los Angeles (UCLA), UCLA Health.
“Then we quickly face two scenarios,” Yuan told CURE as part of the ‘Speaking Out’ video series. “[One is] if the patient hits complete response or complete pathological response, then the question would be, should they continue [Keytruda] for one year versus [deciding that] they can stop [treatment] right there?”
Yuan said one such clinical trial, the phase 3 OptimICE-PCR trial, seeks to answer this question. According to the National Cancer Institute, OptimICE-PCR is currently active and aims to compare the effect of continuing treatment with Keytruda versus observation only among patients who have achieved a pathologic complete response following preoperative chemotherapy plus Keytruda.
Adjuvant: Following the primary treatment, such as surgery.
Complete response: The disappearance of cancer.
Neoadjuvant: Before the primary treatment, such as surgery.
Triple-negative breast cancer: When cancer cells do not have estrogen or progesterone receptors and don’t make much or any HER2 protein, according to the American Cancer Society.
The standard of care for patients with early-stage triple-negative breast cancer who are treated with preoperative chemotherapy plus Keytruda is to receive up to 27 weeks of Keytruda after surgery. However, as noted on the National Cancer Institute’s website, “this trial may help researchers determine if observation is as good as receiving [Keytruda] for 27 weeks after surgery in triple-negative breast cancer patients who achieved a pathologic complete response after preoperative treatment with chemotherapy and [Keytruda].”
“The idea is that [researchers are asking], ‘Can we spare unnecessary treatment?’ Because these treatments can have long-term side effects or autoimmune side effects from immune checkpoint inhibitors,” Yuan said.
On the other hand, Yuan noted, “The opposite question would be: What if our patient has not hit complete pathological response, and they do face relatively high risk of recurrence? What else can we do to perhaps further reduce the risk and then bring some of the cutting-edge drugs to the up-front [setting] to prevent recurrence, rather than treat them later, when disease [has] relapsed and [has] become no longer curable?”
To answer that question, there is the now-active phase 3 clinical trial known as ASCENT-05/AFT-65 OptimICE-RD/NSABP B-63, studying the antibody-drug conjugate Trodelvy (sacituzumab govitecan-hziy) and Keytruda versus treatment of physicians’ choice among patients with triple-negative breast cancer with residual invasive disease after surgery and neoadjuvant therapy.
Yuan explained that Trodelvy consists of an antibody targeting TROP2 receptors, which are highly expressed on the surface of cancer cells, linked with a small amount of a chemotherapy drug. “It’s already FDA approved in the metastatic setting, so now this drug is being studied up front in the adjuvant setting to compare with the standard care, which typically [consisted] of six months of oral capecitabine and in combination with [Keytruda],” Yuan said.
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