A plain language summary of the TROPiCS-02 study in patients with breast cancer (HR-positive/HER2-negative)

Plain Language Summary

What is this summary about?

Sacituzumab govitecan (brand name: TRODELVY^®) is a new treatment for certain types of advanced or metastatic breast cancer. One common type of breast cancer has at least 1 of 2 hormone receptors (HR positive) and does not have human epidermal growth factor 2 (HER2 negative). The HR and HER2 receptors are known to influence how severe a case of breast cancer is. Certain treatments will only work if a specific receptor is present on breast cancer cells. HR-positive/HER2-negative advanced or metastatic breast cancer can be treated with sacituzumab govitecan. This is a summary of the results of the TROPiCS-02 study. This study compared sacituzumab govitecan with standard chemotherapy in participants with HR-positive/HER2-negative advanced or metastatic breast cancer.

What were the results?

The study showed that participants treated with sacituzumab govitecan lived significantly longer without their cancer getting worse than participants treated with chemotherapy. Participants also survived significantly longer and their tumors became significantly smaller in more participants treated with sacituzumab govitecan than with chemotherapy. In general, participants treated with sacituzumab govitecan were more likely to have side effects and had more severe side effects. These side effects included low levels of a type of white blood cell known as neutrophils and diarrhea. Oncologists (doctors that treat cancer) know of these side effects as they are common among people being treated for cancer. Doctors can control these side effects by following standard treatment guidelines and the package insert for sacituzumab govitecan. Participants treated with sacituzumab govitecan maintained their sense of well-being and ability to do daily activities (quality of life) longer than participants treated with chemotherapy. It also took longer for fatigue and other symptoms of cancer to worsen in participants treated with sacituzumab govitecan compared with chemotherapy.

What do the results mean?

Sacituzumab govitecan is more effective than standard chemotherapies for people who have already received multiple treatments for HR-positive/ HER2-negative advanced breast cancer. The side effects from sacituzumab govitecan could generally be managed well by doctors. Although there were more side effects with sacituzumab govitecan than with chemotherapy, they were generally mild to moderate.

A plain language summary of the TROPiCS-02 study shows that sacituzumab govitecan provided significant clinical benefit compared to chemotherapy with manageable side effects for people with pretreated HR-positive and HER2-negative metastatic breast cancer

Keywords: :

• antibody-drug conjugate
• breast
• breast cancer
• HER2-negative
• HR-positive
• lay summary
• plain language summary
• sacituzumab govitecan
• Trop-2

Acknowledgments

The authors would like to thank the study participants and their caregivers and families for their participation and commitment to clinical research. Thank you to the clinical trial investigators and their team members, without whom this work would not be possible.

Financial & competing interests disclosure

The study was sponsored by Gilead Sciences, Inc., and was designed through a collaboration of the sponsor and lead investigators. HS Rugo reports institutional research funding from Astellas Pharma, AstraZeneca, Daiichi Sankyo, F Hoffman-La Roche AG/Genentech, Gilead Sciences, Inc., GlaxoSmithKline, Lilly, Merck, Novartis, OBI Pharma, Pfizer, Pionyr Immunotherapeutics, Sermonix Pharmaceuticals, Stemline Therapeutics, Taiho Oncology and Veru and consulting fees from Daiichi Sankyo, NAPO and Puma. A Bardia reports institutional research funding from Genentech, Novartis, Pfizer, Merck, Sanofi, Radius Health/Menarini, Immunomedics/Gilead, Inc., Daiichi Pharma/AstraZeneca and Eli Lilly and consulting fees from Pfizer, Novartis, Genentech, Merck, Radius Health/Menarini, Immunomedics/Gilead Sciences, Inc, Sanofi, Daiichi Pharma/AstraZeneca, Phillips, Eli Lilly, Foundation Medicine. F Marmé reports institutional research funding from Roche, Novartis, AstraZeneca, GSK/Tesaro, MED, Clovis, Vaccibody, Gilead Sciences, Inc., and Eisai; consulting fees from AstraZeneca, TESARO/GSK, Pfizer, Eisai, Gilead Sciences, Inc., Vaciibody and GenomicHealth; honoraria from AstraZeneca, Clovis, GSK/Tesaro, Eli Lilly, Novartis, Pfizer, Roche, Myriad Genetics, PharmaMar, Eisai, MSD, Immunomedics/Gilead Sciences, Inc., Pierre-Fabre, Agendia, Genomic Health and Seattle Genetics; support for meeting attendance/travel from Pfizer, Roche and AstraZeneca; and data safety monitoring board or advisory board from Palleos and Amgen. J Cortés reports institutional research funding from Roche, Ariad Pharmaceuticals, AstraZeneca, Baxalta, GMBH/Servier Affaires, Bayer HealthCare, Eisai, F Hoffman-La Roche, Guardant Health, Merck Sharp & Dohme, Pfizer, Piqur Therapeutics, Puma, Queen Mary University of London; consulting fees from Roche, Celgene, Cellestia, AstraZeneca, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Lilly, Merck, Sharp & Dohme, GSK, Leuko, Bioasis, Clovis Oncology, Boehringer Ingelheim, Ellipses, Hibercell, BioInvent, Gemoab, Gilead Sciences, Inc., Menarini, Zymeworks, Reveal Genomics and Expres2ion Biotechnologies; honoraria from Roche, Novartis, Celgene, Eisai, Pfizer, Samsung Bioepis, Lilly, Merck, Sharp & Dohme and Daiichi Sankyo; travel and accommodations from Roche, Novartis, Eisai, Pfizer, Daiichi Sankyo, AstraZeneca and Gilead Sciences, Inc; stock ownership from MedSIR and Nektar Pharmaceuticals; and multiple patents. P Schmid institutional research funding from Astellas, AstraZeneca, Genentech, Novartis, Oncogenex, Roche and Medivation; consulting fees from AstraZeneca, Bayer, Boehringer Ingelheim, Merck, Novartis, Pfizer, Puma, Roche, Eisai and Celgene; and spouse’s employment at Roche. P Spears reports consulting fees for advisory committee from Pfizer, Inc. SM Tolaney reports research funding from Gilead Sciences, Inc, AstraZeneca, Eli Lilly, Merck, Nektar, Novartis, Pfizer, Genentech/Roche, Exelixis, BMS, Eisai, Nanostring, Cyclacel, Sanofi, Odonate and SeaGen; consulting fees from AstraZeneca, Eli Lilly, Merck, Nektar, Novartis, Pfizer, Genentech/Roche, Gilead Sciences, Inc., BMS, Eisai, Nanostring, Sanofi, Odonate, SeaGen, Daiichi Sankyo, Athenex, CytomX, Blueprint Medicines, Zentalis, Zymeworks, Ellipses Pharma, 4D Pharma, OncoSec, Infinity Therapeutics, BeyondSpring Pharma, OncXerna, Reveal Genomics, ARC Therapeutics, Kyowa Kirin Pharma, G1 Therapeutics, Silverback Therapeutics, Certara, Mersana Therapeutics and OncoPep; and honoraria from Chugai, Genentech/Roche, Eisai, Gilead Sciences, Inc., AstraZeneca and BMS. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Medical writing disclosure

Medical writing and editorial assistance were provided by Larry Rosenberg, PhD, and Shala Thomas, PhD, CMPP, of Team 9 Science, and by Ben Labbe, PhD, CMPP, of Parexel, funded by Gilead Sciences, Inc.

Open access

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/4.0/