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Study of Safety and Efficacy of Durvalumab in Combination With Paclitaxel in Metastatic Triple Negative Breast Cancer Patients

NCT02628132 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2020-07-07

No results posted yet for this study

Summary

The expression of PD-L1 in breast cancer has been previously demonstrated (Ghebeh et al 2006). In addition, PD-L1 has been shown to work as a "molecular shield", by protecting cancer cells from cytotoxic T-cells and chemotherapy induced apoptosis (Ghebeh et al 2008) suggesting to combine PD-L1 blockade with chemotherapy.

This trial will test Durvalumab in combination with Paclitaxel on metastatic triple-negative breast cancer patients. The safety profile of Durvalumab as a monotherapy has been previously established (lu et al 2015). In this trial the safety profile and tolerability of Durvalumab given in combination of Paclitaxel will be tested. In addition, the efficacy of this combination on metastatic breast cancer will be monitored.

Conditions

Interventions

DRUG

Paclitaxel

Paclitaxel will be given weekly for 6 cycles

DRUG

Durvalumab

Durvalumab will be given q2 wks concurrently with paclitaxel.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • King Faisal Specialist Hospital & Research Center

    lead OTHER

Principal Investigators

  • Hazem Ghebeh, B.Pharm, Ph.D. · Research Center, King Faisal Specialist Hospital & Research Center

  • Taher Al-Tweigeri, M.D. · Oncology Center, King Faisal Specialist Hospital & Research Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2019-12-31
Completion
2020-03-24

Countries

  • Saudi Arabia

Study Locations

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Entities

Drugs
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 NCT02628132 on ClinicalTrials.gov