Delving Into Clinical Research For Patients With Breast Cancer

There are currently a number of clinical trials looking to advance new treatment options for patients with HER2-positive and HER2-negative breast cancer, Dr. Yuan Yuan explained to CURE®.

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 UCLA, sat down for an interview with CURE® as part of the “Speaking Out” video series.

“We know that [over] the past two, three decades, we have had made major progresses in HER2-positive disease. A lot of the patients — up to two-thirds of these high-risk, early stage HER2-positive patients — achieve complete pathological response,” said Yuan. “But in the adjuvant setting, if they don't hit complete response, the current standard care is give them T-DM1 [ado-trastuzumab emtansine, also known as] Kadcyla as adjuvant therapy, but we still encounter patients [who] may have brain metastasis years later [and] may still face a certain risk of recurrence.”

To that end, the phase 3 CompassHER2 RD trial is set to study how well Kadcyla and Tukysa (tucatinib) work together to prevent breast cancer relapse among patients with high-risk, HER2-positive breast cancer. Kadcyla is an antibody-drug conjugate, consisting of a monoclonal antibody linked to a chemotherapy drug, while Tukysa in a tyrosine kinase inhibitor that may stop the growth of tumor cells, according to the trial’s listing on clinicaltrials.gov.

The trial, according to its listing, started in 2021 and is still recruiting patients. With an estimated eventual enrollment of 1,031 patients, the trial has an estimated primary completion date of Jan. 31, 2028, and an estimated study completion date of May 31, 2035.

More Notable Clinical Trials

Regarding patients with HER2-negative, estrogen receptor (ER)-positive breast cancer, the phase 3 KEYNOTE-756 study is evaluating the immunotherapy Keytruda (pembrolizumab) versus placebo in combination with neoadjuvant chemotherapy and adjuvant endocrine therapy, Yuan said.

The trial is now active, with approximately 1,240 patients, and is estimated to be completed by Jan. 24, 2031, according to its listing on clinicaltrials.gov.

Additionally, the Southwestern Oncology Group, or SWOG, is currently running a phase 3 trial incorporating the immunotherapy Imfinzi (durvalumab) in the treatment of patients with hormone receptor (HR)-positive, HER2-negative breast cancer, Yuan said.

The trial, according to its listing on clinicaltrials.gov, started in 2023 and is currently recruiting patients. With an estimated eventual enrollment of 3,680 patients, it is estimated to be completed by May 31, 2026.

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