AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer (GELATO)

Netherlands Cancer Institute (NKI)

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Atezolizumab; Drug: Carboplatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03147040

M17GEL

Details and patient eligibility

About

This is a single arm multicenter non-randomized phase II trial testing the efficacy of the combination of carboplatin plus atezolizumab in metastatic ILC

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed and written informed consent
• Age 18 year or older
• Metastatic or incurable locally advanced lobular breast cancer with confirmation of the lobular histology and E-cadherin loss on a biopsy of a metastatic lesion.
• Metastatic lesion accessible for histological biopsies
• Evidence of progression of disease
• A maximum of two lines of palliative chemotherapy
• WHO performance status of 0 or 1
• Evaluable disease or measurable according to RECIST 1.1

Exclusion criteria

• Leptomeningeal disease localization
• History of having received other anticancer therapies within 2 weeks of start of the study drug
• History of immunodeficiency, autoimmune disease, conditions requiring immunosuppression
• Prior treatment with immune checkpoint blockade
• Live vaccine within 2 weeks prior to start of study
• Active other cancer
• Active hepatitis B

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

23 participants in 1 patient group

Carboplatin/Atezolizumab

Experimental group

Description:

Carboplatin AUC=1.5, weekly schedule, maximum 12 administrations Atezolizumab, 1200 mg flat dose, 3-weekly schedule, starting after two administrations of carboplatin

Treatment:

Drug: Atezolizumab

Drug: Carboplatin