Study of Safety and Efficacy of Durvalumab in Combination With Paclitaxel in Metastatic Triple Negative Breast Cancer Patients
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|ClinicalTrials.gov Identifier: NCT02628132|
Recruitment Status : Recruiting
First Posted : December 11, 2015
Last Update Posted : March 30, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Paclitaxel Drug: Durvalumab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of the Safety, Tolerability and Efficacy of the Investigational Anti PD-L1 Monoclonal Antibody Durvalumab in Combination With Paclitaxel in Patients With Metastatic Triple Negative PD-L1 Positive Breast Cancer|
|Actual Study Start Date :||November 2016|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Durvalumab and Paclitaxel
After one cycle of paclitaxel, durvalumab will be given concurrently with paclitaxel. Once paclitaxel cycles are completed, durvalumab will be continued alone until disease progression or unacceptable toxicity.
Paclitaxel will be given weekly for 6 cycles
Durvalumab will be given q2 wks concurrently with paclitaxel.
Other Name: MEDI4736
- Number of patients with adverse events (severe and non-severe) [ Time Frame: 12 months ]
- Objective response rate (ORR) [ Time Frame: 24 months ]
- Progression free survival [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02628132
|Contact: Taher Al-Tweigeri, M.D.||+firstname.lastname@example.org|
|Contact: Hazem Ghebeh, B.Pharm, Ph.D.||+email@example.com|
|King Faisal Specialist Hospital and Research Center||Recruiting|
|Riyadh, Saudi Arabia, 11211|
|Contact: Taher Al-Tweigeri, M.D. +966550484144 firstname.lastname@example.org|
|Principal Investigator:||Hazem Ghebeh, B.Pharm, Ph.D.||Research Center, King Faisal Specialist Hospital & Research Center|
|Principal Investigator:||Taher Al-Tweigeri, M.D.||Oncology Center, King Faisal Specialist Hospital & Research Center|