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Updated: Jan 28, 2026

Studying Triple Negative Breast Cancer Using Orthotopic Breast Cancer Model
Published on: March 20, 2020
Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer
Aditya Bardia1, Ingrid A Mayer1, Linda T Vahdat1
1From the Massachusetts General Hospital Cancer Center (A.B., S.J.I.) and Dana-Farber Cancer Institute (S.M.T.), Harvard Medical School, Boston; Vanderbilt-Ingram Cancer Center, Nashville (I.A.M., V.G.A.); Weill Cornell Medical College (L.T.V.) and New York-Presbyterian-Columbia University Irving Medical Center (K.K.), New York; University of Colorado Cancer Center, Aurora (J.R.D.); Texas Oncology, Baylor University Medical Center, US Oncology, Dallas (J.O.); Orlando Health University of Florida Health Cancer Center, Orlando (R.L.M., N.C.S.); Yale University School of Medicine, New Haven, CT (A.D.S.); University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (H.S.R.); Immunomedics, Morris Plains, NJ (D.M.G., R.I., S.W., R.M.S., W.A.W.); and AIS Consulting, Ann Arbor, MI (A.M.S.).
Sacituzumab govitecan-hziy demonstrated durable responses in patients with pretreated metastatic triple-negative breast cancer. The antibody-drug conjugate showed a 34.3% response rate and a 13.0-month overall survival, with myelotoxicity as the primary adverse effect.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Metastatic triple-negative breast cancer (TNBC) has poor outcomes with standard chemotherapy.
- Sacituzumab govitecan-hziy is an antibody-drug conjugate targeting Trop-2, delivering SN-38 to tumors.
Purpose of the Study:
- To evaluate the safety and efficacy of sacituzumab govitecan-hziy in patients with pretreated metastatic TNBC.
Main Methods:
- Phase 1/2 single-group, multicenter trial of 108 patients with advanced epithelial cancers.
- Patients received sacituzumab govitecan-hziy (10 mg/kg) intravenously on days 1 and 8 of 21-day cycles.
- Endpoints included safety, objective response rate (ORR), duration of response, clinical benefit rate (CBR), progression-free survival (PFS), and overall survival (OS).
Main Results:
- The ORR was 33.3% (95% CI, 24.6-43.1) by local assessment and 34.3% by independent central review.
- Median duration of response was 7.7 months (local) and 9.1 months (central).
- Median PFS was 5.5 months and median OS was 13.0 months. Grade 3/4 anemia and neutropenia were common adverse events.
Conclusions:
- Sacituzumab govitecan-hziy demonstrated durable objective responses in heavily pretreated metastatic TNBC patients.
- Myelotoxic effects were the primary adverse reactions observed.
- The study was funded by Immunomedics (NCT01631552).
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