CISPLATIN + AZD-1775 In Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03012477|
Recruitment Status : Active, not recruiting
First Posted : January 6, 2017
Last Update Posted : August 14, 2020
This research study is studying a combination of drugs as a possible treatment for triple-negative breast cancer that has spread to other areas of the body. The names of the study interventions involved in this study are:
|Condition or disease||Intervention/treatment||Phase|
|Triple-negative Metastatic Breast Cancer||Drug: Cisplatin Drug: AZD1775||Phase 2|
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved AZD1775 as a treatment for any type of cancer. Cisplatin is FDA approved for other cancers and has been shown to be an active treatment for breast cancer.
AZD1775 is a drug that is designed to block a protein called Wee-1 which may control the ability of certain cancer cells to grow or divide. Cisplatin works by damaging the DNA inside the cancer cells which prevents them from dividing. By combining AZD1775 and Cisplatin, cancer cells may potentially be more effectively killed.
In this research study, the investigators are looking to determine whether the combination of AZD1775 and cisplatin is an effective treatment for triple negative breast cancer that has spread to other parts of the body.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Cisplatin + AZD1775 in Metastatic Triple-negative Breast Cancer and Evaluation of pCDC2 as a Biomarker of Target Response|
|Actual Study Start Date :||January 18, 2017|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||December 2024|
Treatment will consist of one cycle of cisplatin monotherapy (cisplatinIV x1) followed by combination therapy of AZD1775 plus cisplatin starting 21 days later.
- AZD1775 will be administered as twice daily oral dosing predetermined dosing schedule, in combination with Cisplatin predetermined dosage every 21 days.
At least 10 patients will undergo a research biopsy within 5-48 hours after beginning cisplatin (Cycle 1 Day 1) and then again within 5-8 hours after the last dose of AZD1775 in cycle 2 (Cycle 2 Day 3).
Cisplatin will be given on the first day of every cycle. Each cycle is 21 days long.
Other Name: Platinol
The first dose of AZD1775 will be administered in clinic on the first day of the second cycle. Subsequent doses will be taken approximately 12 hours apart for a total of five doses. Each cycle is 21 days long.
- Objective response rate [ Time Frame: 6 weeks ]RECIST 1.1.
- Progression Free Survival [ Time Frame: From date of initiation of study treatment until the date of first documented progression or date of death from any cause, whichever came first (approximately 5 years ). ]PFS will be estimated by the method of Kaplan and Meier.
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): NCT03012477
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Sara Tolaney, MD, MPH||Dana-Farber Cancer Institute|