HER2 Expression Determines Benefit of Sacituzumab Govitecan in HR+ Breast Cancer

An expert from Dana-Farber Cancer Institute describes which patients hormone receptor-positive, HER2-negative breast cancer will benefit most from treatment with sacituzumab govitecan.

For those pre-treated with CDK4/6 inhibitors or prior chemotherapy for advanced hormone receptor (HR)-positive, HER2-negative breast cancer, sacituzumab govitecan (Trodelvy) is a “nice choice” for patients, according to Sara M. Tolaney, MD, MPH.

CancerNetwork® spoke with Tolaney, chief of the Division of Breast Oncology and associate director of the Susan F. Smith Center for Women’s Cancer at Dana-Farber Cancer Institute, and associate professor of medicine at Harvard Medical School, in Boston, ahead of the FDA’s approval of sacituzumab govitecan in HR-positive, HER2-negative breast cancer.1

Approval of sacituzumab in this patient population was supported by data from the phase 3 TROPiCS-02 trial (NCT03901339), in which the agent produced a 34% reduction in the risk of progression or death compared with standard chemotherapy.2

Tolaney also spoke about the specific benefits of sacituzumab compared with similar agents including trastuzumab deruxtecan (T-DXd; Enhertu), distinguishing their uses based on HER2 expression. “…T-DXd really is just for those patients who are HER-2 low at this time,” she explained. “So, for those patients who are HER2-zero, using sacituzumab earlier is really nice.”

Tolaney also briefly discussed the next steps in researching the use of sacituzumab in earlier clinical settings.


Right now, the data that we have for sacituzumab really did focus on those patients who had 2 to 4 lines of prior chemotherapy for metastatic disease. TROPiCS-02 did allow patients to have had 1 line if they had had early relapse after their adjuvant therapy. The right population [for sacituzumab] is someone who's had prior chemotherapy in the metastatic setting and prior CDK4/6 inhibition; then this agent becomes a very nice choice.

One of the conundrums that's often coming up in the clinic currently is we do have trastuzumab deruxtecan [T-DXd] as an alternative option to chemotherapy in hormone receptor-positive disease, and now we will have sacituzumab. And so, how does one think about sequencing them? Again, the T-DXd really is just for those patients who are HER2-low at this time. So, for those patients who are HER2-zero, using sacituzumab earlier is really nice. [It is] even [useful] in HER2-low [disease] given the setting where this agent was studied; it certainly can be used post–T-DXd, as well.

But it's really important that we get more data for using sacituzumab [in earlier lines of treatment]. There are actually ongoing trials addressing this. There's a first-line study in the metastatic setting looking at sacituzumab compared to standard therapy. And our group actually also has a study combining sacituzumab with immunotherapy in hormone receptor-positive disease, as well.


  1. U.S FDA approves Trodelvy in pre-treated HR+/HER2- metastatic breast cancer. News release. Gilead. February 3, 2023. Accessed February 3, 2023. https://bwnews.pr/3Y0bftX
  2. U.S. FDA accepts for priority review the supplemental biologics license application for Gilead’s Trodelvy® for pre-treated HR+/HER2- metastatic breast cancer. News release. Gilead Sciences. October 11, 2022. Accessed February 2, 2023. Bit.ly/3YifctN
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