Durvalumab in Patients With HER-2 Positive Metastatic Breast Cancer Receiving Trastuzumab
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|ClinicalTrials.gov Identifier: NCT02649686|
Recruitment Status : Completed
First Posted : January 7, 2016
Last Update Posted : April 9, 2020
The purpose of this study is to find the highest dose of durvalumab that can be tolerated without causing very severe side effects when receiving standard treatment and to see what effects the study drug has on this type of cancer.
The researchers doing this study are also interested in looking for markers that will help predict which patients are most likely to be helped by durvalumab when receiving standard treatment and what effects durvalumab has on this type of cancer.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: Durvalumab Drug: Trastuzumab||Phase 1|
The standard or usual treatment for this type of disease at this point is to receive a drug called trastuzumab that targets the HER-2 receptor. Durvalumab is a new type of drug for many types of cancer. This drug is an antibody and laboratory tests show that it works by allowing the immune system to detect your cancer and reactivating the immune response. This may help to slow down the growth of cancer or may cause cancer cells to die. Durvalumab has been shown to shrink tumours in animals and has been studied in a few people and seems promising but it is not clear if it can offer better results than standard treatment alone.
The use of durvalumab when receiving standard treatment is being studied because it is thought that one way of over-coming resistance to the standard therapy is to add a drug that activates the immune system, as durvalumab has been shown to do, thus "re-sensitizing" immune function to kill cancer cells.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b Pharmacodynamic Study of Durvalumab (MEDI4736) in Patients With HER-2 Positive Metastatic Breast Cancer (MBC) Receiving Trastuzumab|
|Actual Study Start Date :||April 21, 2016|
|Actual Primary Completion Date :||September 25, 2017|
|Actual Study Completion Date :||November 12, 2019|
Experimental: Durvalumab plus Trastuzumab
Durvalumab q3w until PD Trastuzumab q3w x 6
- Confirm the recommended phase II dose of durvalumab given to patients with advanced/recurrent HER-2 positive metastatic breast cancer (MBC) who are receiving treatment with trastuzumab [ Time Frame: 18 months ]
- Number of participants with treatment related adverse events as assessed by CTCAE V 4.0 [ Time Frame: 18 month ]
- Measure response rate of durvalumab measured by RECIST 1.1/Immune Response Criteria) in patients receiving trastuzumab [ Time Frame: 18 months ]
- Measure clinical benefit rate of durvalumab measured by RECIST 1.1/Immune Response Criteria) in patients receiving trastuzumab [ Time Frame: 18 months ]
- Assess PD-L1 expression in paired biopsies pre and post treatment with durvalumab as a marker of response/benefit [ Time Frame: 18 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): NCT02649686
|Canada, British Columbia|
|BCCA - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Ottawa Hospital Research Institute|
|Ottawa, Ontario, Canada, K1H 8L6|
|University Health Network|
|Toronto, Ontario, Canada, M5G 2M9|
|Study Chair:||Stephen Chia||BCCA-Vancouver Cancer Centre, Vancouver BC, Canada|