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Crizotinib in Lobular Breast, Diffuse Gastric and Triple Negative Lobular Breast Cancer or CDH1-mutated Solid Tumours

NCT03620643 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-10-30

Study results available
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Summary

The purpose of this study was to find out how effective the combination of crizotinib and fulvestrant was in shrinking lobular breast cancer tumours. The investigators also assessed the side effects of the combination of crizotinib tablets and fulvestrant injections. The side effects and the doses of crizotinib and fulvestrant had already been evaluated in large clinical trials, but this was the first time these two drugs had been combined together.

Conditions

Interventions

DRUG

Crizotinib Oral Capsule [Xalkori]

Crizotinib 250 mg Crizotinib 200mg

DRUG

Fulvestrant 50 MG/ML Prefilled Syringe [Faslodex or generic]

Fulvestrant (Faslodex or generic) is supplied as two 5-mL clear neutral glass (Type 1) barrels, each containing 250mg/5mL of fulvestrant solution for intramuscular injection and fitted with a tamper evident closure.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Breast Cancer Now

    collaborator OTHER

  • Royal Marsden NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Professor Peter Schmid · St Bart's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-09
Primary Completion
2024-08-30
Completion
2024-08-30
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03620643 on ClinicalTrials.gov