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ASCENT-03: A New UK Clinical Trial for TRODELVY® & Metastatic Triple Negative Breast Cancer

22nd March 2023 by Alexander Kolliari-Turner

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A new Clinical Trial of TRODELVY® for previously untreated secondary Triple Negative Breast Cancer (TNBC) is now recruiting in the UK: ASCENT-03

Sacituzumab govitecan-hziy (known by the trade name TRODELVY®) was approved for NHS usage in 2022 for secondary TNBC patients, who have had two or more systemic therapies (such as chemotherapies), with at least one of these being for advanced disease.  

TRODELVY® was approved for this demographic of secondary TNBC patients because a phase 3 clinical trial (known as the ASCENT trial) showed positive patient outcomes. In this trial, TRODELVY® was compared to treatment of physician's choice (which included chemotherapies such as eribulin). When the treatment groups are compared, TRODELVY® showed better outcomes on reducing tumour size, and extending the length of time until the cancer got worse and the length of time patients stayed alive. The National Institute for Health and Care Excellence (NICE) committee who recommended TRODELVY® for this patient demographic, said that from these results TRODELVY® was a “highly effective treatment” for patients who can have a poor prognosis.

TRODELVY® is now being researched (the ASCENT-03 trial) in previously untreated secondary TNBC patients as a new first line of treatment. The ASCENT-03 trial is being conducted globally and is now recruiting in London at Barts Health NHS Trust & University College London Hospitals NHS Foundation. More locations could be added in the future and the estimated primary completion date of the study is May 2027. 

The primary aim of ASCENT-03 is to compare a group of patients who receive TRODELVY® to those who receive treatment of physician's choice (chemotherapies such as paclitaxel, which are current standard of care) and investigate the time taken until the cancer progresses and gets worse. There is a possibility that, as found in the ASCENT trial, TRODELVY® could extend the length of time until the cancer progresses and gets worse but the full clinical trial dataset will need to be analysed to answer this question. ASCENT-03 aims to recruit approximately 540 patients and patients would be assigned to one of these two groups by random.  

TRODELVY® is a type of targeted biological therapy that can deliver chemotherapy to cancer cells in a more targeted manner and subsequently cause less side effects than other non-targeted chemotherapy regimens (which are the current standard of care in this setting). TRODELVY® is made by Gilead Sciences

Although TNBC tumours lack the three main receptor types (ER, PR & HER2) used to classify breast cancer patients for treatments, many TNBC tumours do have above normal levels of a protein called TROP2 on their surface. TRODELVY® binds to TROP2 and delivers a chemotherapy drug (SN-38) directly into the TNBC cells to stop them from growing. 

If you are a secondary breast cancer patient who is interested in learning more about Clinical Trials you can enrol into the Patient Trials Advocate (PTA) service. The PTA service is run by experienced research nurses and funded by Make 2nds Count. The PTA service provides information to patients on clinical trials and can be accessed here

Make 2nds Count also curates a registry of all actively recruiting clinical trials within the UK.