Real-world effectiveness and safety of Sacituzumab Govitecan in metastatic triple-negative breast cancer: Results from the multicenter retrospective observational SACISUR cohort in Southern Spain

Alejandro Falcón-González^1*Elisenda Llabrés-Valenti²Fernando Henao-Carrasco³Rocío Urbano-Cubero⁴Ana Godoy Ortiz⁵JULIO CESAR NIETO RAMIREZ⁶Ana Milena Vargas-Prado⁷Alba Gonzalez-Haba⁸Braulio Martin-Calero⁹CRISTINA MORALES ESTEVEZ¹⁰María Valero-Arbizu¹¹Natalia Chavarría-Piudo¹²Encarna Gonzalez-Flores¹³Estefania Casaut-Lora¹⁴Tamara Díaz-Redondo¹⁵Sara Estalella-Mendoza¹⁶Irene Zarcos-Pedrinaci¹⁷David Morales-Pancorbo¹⁸Ariadna Acosta-Sanchez¹⁹Elena Vicente-Rubio²⁰Ana Gil-Torralvo¹⁹Monica Cejuela-Solís¹⁹Ruben de Toro-Salas³Alicia Cano-Jimenez²¹Javier Pascual⁵Antonia Sanchez-Guisado⁶JOSEFINA CRUZ⁹Iciar De la Fuente-Dominguez¹⁰Jose Andres Rodriguez-Garcia²⁰Alberto Torres Zurita³Javier Salvador-Bofill¹⁹Manuel Ruiz-Borrego¹⁹

• ¹Virgen del Rocío University Hospital, Seville, Spain
• ²Hospital CHU Insular Materno Infantil, Gran Canaria, Spain
• ³Hospital Universitario Virgen Macarena, Seville, Spain
• ⁴Hospital Universiario de Jaen, Jaén, Spain
• ⁵Hospital Universitario Virgen de la Victoria, Málaga, Spain
• ⁶Hospital Universitario Torrecardenas, Almería, Spain
• ⁷Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas de Gran Canaria, Spain
• ⁸Hospital Universitario de Badajoz, Badajoz, Spain
• ⁹Centro Hospitalario de Canarias, Tenerife, Spain
• ¹⁰Hospital Universitario Reina Sofia, Córdoba, Spain
• ¹¹Hospital quiron Salud-Oncoavanze, Sevilla, Spain
• ¹²Hospital Universitario de Jerez de la Frontera, Jerez de la Frontera, Spain
• ¹³Hospital Universitario Virgen de las Nieves, Granada, Spain
• ¹⁴Hospital de Puerto Real, Cadiz, Spain
• ¹⁵Hospital Regional Universitario de Malaga, Málaga, Spain
• ¹⁶Hospital Universitario Puerta del Mar, Cádiz, Spain
• ¹⁷Hospital Universitario Costa del Sol, Marbella, Spain
• ¹⁸Hospital Universitario Juan Ramon Jimenez, Huelva, Spain
• ¹⁹Hospital Universitario Virgen del Rocio, Seville, Spain
• ²⁰Hospital Universitario Insular de Gran Canaria, Las Palmas de Gran Canaria, Spain
• ²¹Universidad de Jaen, Jaén, Spain

Background: Sacituzumab govitecan (SG) has demonstrated efficacy in metastatic triple-negative breast cancer (mTNBC) in clinical trials, but real-world data from routine clinical practice remains limited. This study aimed to evaluate the effectiveness and safety of SG in mTNBC patients in Southern Spain. Methods: This observational, multicenter, retrospective study included 159 mTNBC patients who received at least one cycle of SG between January 2022 and December 2023. Primary endpoints included real-world progression-free survival (rwPFS), overall survival (rwOS), and safety. Secondary endpoints explored treatment tolerability and management of adverse events. A pre-specified subset analysis focused on patients with central nervous system (CNS) metastases. Results: The median age of patients at diagnosis was 50 years (46.5% premenopausal). Median rwPFS was 4.6 months (95% CI 3.7-6.3) and rwOS was 10.9 months (95% CI 7.6-14.2). The objective response rate was 31.2%, with a disease control rate of 68.9%. Patients with CNS metastases (13.8%) had a median rwPFS of 2.3 months (95% CI 1.3-3.2). The most common adverse events were neutropenia (59.4%, grade 3-4: 30.4%) and diarrhea (49%, grade 3-4: 8.2%). Granulocyte colony-stimulating factor was administered as primary prophylaxis in 29.6% of patients and as secondary prophylaxis in 17.6%. Treatment discontinuation due to adverse events occurred in 5.7% of patients, while 43.4% required at least one dose reduction. Conclusion: SG demonstrated effectiveness and tolerability in mTNBC patients treated in routine practice, including those with CNS metastases, consistent with ASCENT trial results. These findings support the use of SG in clinical practice for mTNBC patients and suggest clinically meaningful activity and a manageable safety profile in patients with CNS involvement, despite the clinical challenges presented by this subgroup.