Trial to Evaluate Efficacy and Safety of Pembrolizumab and Gemcitabine in HER2-negative ABC

Summary

Study Design and Treatment: This is a multicenter phase II trial, with an initial exploratory run-in-phase, to evaluate the efficacy and safety of pembrolizumab in combination with gemcitabine in patients with HER2-negative ABC that have previously received anthracyclines and taxanes (unless clinically contraindicated). In hormone receptor positive patients, previous treatment with 2 or more lines of hormone therapy will also be required. Patients must have at least one measurable lesion that can be accurately assessed at baseline and is suitable for repeated assessment by CT, MRI or plan X-ray. Approximately 53 patients (up to a maximum of 65 patients depending on the results of the run-in-phase) will be included in this trial.

Timeline

Start

2017-06-28

Primary completion

2019-06-03

Completion

2021-07-22

Outcome

Missed primary endpoint

paper The objective of ORR was not met PMID 36463104 ↗

Publications

• Results de la Cruz-Merino L, Gion M, Cruz J, Alonso-Romero JL, Quiroga V, Moreno F, Andres R, Santisteban M, Ramos M, Holgado E, Cortes J, Lopez-Miranda E, Cortes A, Henao F, Palazon-Carrion N, Rodriguez LM, Ceballos I, Soto A, Puertes A, Casas M, Benito S, Chiesa M, Bezares S, Caballero R, Jimenez-Cortegana C, Sanchez-Margalet V, Rojo F. Pembrolizumab in combination with gemcitabine for patients with HER2-negative advanced breast cancer: GEICAM/2015-04 (PANGEA-Breast) study. BMC Cancer. 2022 Dec 3;22(1):1258. doi: 10.1186/s12885-022-10363-3.
• Results de la Cruz-Merino L, Gion M, Cruz-Jurado J, Quiroga V, Andres R, Moreno F, Alonso-Romero JL, Ramos M, Holgado E, Cortes J, Lopez-Miranda E, Henao-Carrasco F, Palazon-Carrion N, Rodriguez LM, Ceballos I, Casas M, Benito S, Chiesa M, Bezares S, Caballero R, Jimenez-Cortegana C, Sanchez-Margalet V, Rojo F. Pembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) Study. Cancers (Basel). 2021 Oct 29;13(21):5432. doi: 10.3390/cancers13215432.

Drugs

Indications