Tokyo, Aug. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062648) titled 'Phase I/II study evaluating the safety, tolerability, and efficacy of sacituzumab govitecan in combination with pegfilgrastim in patients with HER2-negative breast cancer' on Aug. 21.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Rakuwakai Otowa Hospital

Condition: Condition - Unresectable or recurrent HER2-negative breast cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The purpose of this clinical trial is to evaluate whether subcutaneous injection of pegfilgrastim, a long-acting G-CSF formulation, on day 2 of the treatment cycle can prevent neutropenia and allow safe and on-schedule intravenous infusion of sacituzumab govitecan on day 8. In addition, a preliminary analysis of the relationship between Trop-2 expression and clinical outcomes will be explored. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - In a 21-day cycle, sacituzumab govitecan (Trodelvy) 10 mg/kg will be administered intravenously on day 1 and day 8, and pegfilgrastim (preceding product "G-Lasta" or generic drug "Pegfilgrastim BS subcutaneous injection 3.6 mg") will be administered subcutaneously on day 2.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Japanese male or female patients aged 20 years or older who can understand the study contents and provide written informed consent. Patients with locally advanced, inoperable, or metastatic TNBC (triple-negative breast cancer) or hormone receptor-positive and HER2-negative breast cancer who have received previous chemotherapy for locally advanced, inoperable, or metastatic disease. Key exclusion criteria - Patients harboring both homozygotes for UGT1A1*6 and heterozygotes for UGT1A1*6 and UGT1A1*28, as well as homozygosity for UGT1A1*28. Patients with active infections. Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 20 Day Date of IRB - 2026 Year 08 Month 20 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2032 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071333

Disclaimer: Curated by HT Syndication.