Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients with Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer (ASCENT-03)

Clinical Trial Title

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1

The purpose of this study is to see if the drug sacituzumab govitecan can improve lifespans of participants with advanced triple-negative breast cancer (TNBC) and their tumor does not grow or spread when compared to chemotherapy (paclitaxel, or nab-paclitaxel, or the combination of gemcitabine and carboplatin), a commonly used treatment for previously untreated advanced TNBC. “Investigational” means that the U.S. Food and Drug Administration (FDA) has not approved this treatment as a prescription medicine and it must be tested to see if it is a safe and effective treatment method for this disease. 

If you qualify to join this study, your participation may last up to 5 years and you will be asked to complete study visits at least 2-3 times per cycle (1 cycle consists of 21 or 28 days), depending on which treatment group you are assigned. During the follow-up period, you may be required to visit the clinic every 12 weeks or more frequently.

In order to participate you must meet the following criteria:

• Are female or male and 18 years of age or older.
• Have previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (TNBC).
• Have measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) and confirmed by your doctor.

You will be excluded from the study if any of the following criteria apply to you:

• Have positive blood pregnancy test or are lactating.
• Have received systemic anticancer treatment within the previous 6 months or radiation therapy within 2 weeks prior to enrollment.
• Have previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor.
• Have active second malignancy.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.