BIG 18-03

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A Randomized Phase II Study to Evaluate the Incidence of Discontinuations due to Diarrhoea at 3 Cycles in patients with Early-stage HER2-positive (HER2+), Hormone Receptor-positive (HR+) Breast Cancer treated with Neratinib plus Loperamide prophylaxis versus Neratinib with Initial Dose Escalation plus PRN Loperamide prophylaxis versus Neratinib plus Loperamide plus Colesevelam prophylaxis.

Phase II study to evaluate diarrhoea discontinuations at 3 cycles in patients with early-stage HER2 positive, hormone receptor positive breast cancer treated with neratinib plus loperamide versus neratinib dose escalation plus loperamide administered as needed versus neratinib plus loperamide plus colesevelam

To evaluate the incidence of neratinib discontinuations due to diarrhoea within the first 3C (1C = 28 days) in patients with early-stage HER2 overexpressed/amplified (HER2+), hormone receptor-positive (HR+) breast cancer who have completed adjuvant trastuzumab-based therapy.

– Incidence and time of neratinib discontinuations due to any treatment-emergent adverse event (TEAE).
– Diarrhoea due to neratinib: incidence, duration, severity, and treatment interventions.
– Incidence of neratinib discontinuation due to any reason.
– Incidence of hospitalisations (overall and for diarrhoea).
– Incidence of TEAEs and serious adverse events (SAEs) and adverse events of special interest (AESIs, ie, hepatic, cardiac, pulmonary, reproductive and developmental).
– Neratinib exposure assessment.
– Determine the effect of study treatment on quality of life, as measured by patient reported outcomes, in all treatment arms.

Aim: 315 patients in the whole clinical trial, from 55 study locations.


Actual Study Start Date:August 31, 2022
Estimated Primary Completion Date:March 25, 2025
Estimated Study Completion Date:

January 2030

55 study locations are involved in Spain and other EU countries.

Sponsor: GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)


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