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Pembrolizumab And Tamoxifen Among Women With Advanced Hormone Receptor Positive Breast Cancer And Esr1 Mutation

NCT03879174 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-03-18

No results posted yet for this study

Summary

Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) designed to directly block the interaction between PD-1 and its ligands and enable the T cell to remain active and co-ordinate an attack on tumor cells.

We hypothesise that the Clinical Benefit Rate (CBR) and progression free survival (PFS) of metastatic breast cancer patients who have ESR1 mutation will improve following administration of a combination of pembrolizumab and tamoxifen.

Conditions

  • Breast Cancer Female

Interventions

DRUG

Pembrolizumab + Tamoxifen

The choice of the 200 mg Q3W as an appropriate dose for the switch to fixed dosing is based on simulations performed using the population PK model of pembrolizumab showing that the fixed dose of 200 mg every 3 weeks will provide exposures that 1) are optimally consistent with those obtained with the 2 mg/kg dose every 3 weeks, 2) will maintain individual patient exposures in the exposure range established in melanoma as associated with maximal efficacy response and 3) will maintain individual patients exposure in the exposure range established in melanoma that are well tolerated and safe. A fixed dose regimen will simplify the dosing regimen to be more convenient for physicians and to reduce potential for dosing errors. A fixed dosing scheme will also reduce complexity in the logistical chain at treatment facilities and reduce wastage.

Sponsors & Collaborators

  • Mediclinic Middle East

    lead INDUSTRY

Principal Investigators

  • Matthew Dronsfield · Hospital Director- Mediclinic City Hospital

  • Shaheenah Dawood · Consultant Oncologist

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2022-08-01
Completion
2022-08-01
FDA Drug
Yes

Countries

  • United Arab Emirates

Study Locations

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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 NCT03879174 on ClinicalTrials.gov