Atezolizumab + Pertuzumab + Trastuzumab In CNS Mets In BC
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03417544|
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : December 13, 2019
This research study is studying a drug called atezolizumab as a possible treatment HER2-positive metastatic breast cancer (MBC) that has spread to the brain.
The names of the study drugs involved in this study are:
|Condition or disease||Intervention/treatment||Phase|
|HER2-positive Metastatic Breast Cancer Central Nervous System Metastases||Drug: ATEZOLIZUMAB Drug: PERTUZUMAB Drug: TRASTUZUMAB||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. It also means that the FDA (U.S. Food and Drug Administration) has not approved the combination of atezolizumab, trastuzumab, and pertuzumab for use in humans. The FDA has not approved atezolizumab for this specific disease but it has been approved for other uses.
- Atezolizumab is a protein that affects the immune system by blocking the PD-L1 pathway. The PD-L1 pathway controls the body's natural immune response, but for some types of cancer the immune system does not work as it should and is prevented from attacking tumors. Atezolizumab works by blocking the PD-L1 pathway, which may help the immune system identify and catch tumor cells.
- Pertuzumab and trastuzumab are targeted therapies approved by the FDA to be used alone or in combination with a chemotherapy drug to treat HER2-positive metastatic breast cancer that hasn't been treated with either trastuzumab or chemotherapy yet.
- Pertuzumab and trastuzumab are called "targeted therapies" because they work by attaching themselves to specific receptors on the surface of breast cancer cells, known as HER2 receptors. When these targeted therapies attach to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by your immune system. This process allows pertuzumab and trastuzumab to help slow or stop the growth of the breast cancer. Pertuzumab and trastuzumab target different areas of the HER2 cell, so they are believed to work together more effectively.
In this research study, investigators are looking to see how well the cancer responds to the combination of atezolizumab in combination with pertuzumab and trastuzumab.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Atezolizumab in Combination With Pertuzumab Plus High-dose Trastuzumab for the Treatment of Central Nervous System Metastases in Patients With Her2-positive Breast Cancer|
|Actual Study Start Date :||February 21, 2018|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||February 2025|
Experimental: ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB
Patients will receive the following treatment:
(IV) every 3 weeks
Other Name: Tecentriq
Loading dose, followed every 3 weeks thereafter by a predetermined dose in the protocol via IV
Other Name: Perjeta
Predetermined dose per protocol via IV, weekly for 24 weeks and after every 3 weeks
Other Name: Herceptin
- Overall Response Rate in CNS [ Time Frame: 24 Weeks ]Assessed using RANO-BM criteria
- Progression Free Survival [ Time Frame: 24 Weeks ]Assessed using RANO-BM criteria
- Objective non-CNS response rates [ Time Frame: 24 weeks ]According to RECIST 1.1 and irRC criteria
- Duration Response Rate [ Time Frame: 5 Years ]RANO-BM criteria and descriptive statistics will be used to summarize DOR intervals
- Clinical Benefit Rate [ Time Frame: 18 and 24 weeks ]Incidence of SD, PR, or CR in non-CNS by RECIST 1.1 and in CNS by RANO-BM
- Overall Survival [ Time Frame: 2 years ]Estimate the efficacy as measured by overall survival (OS) of Atezolizumab in combination with High-dose Trastuzumab and Pertuzumab
- Dose Limiting Toxicity [ Time Frame: baseline within 21 days of C1D1 treatment ]Toxicity will be graded according to NCI CTCAE, Version 4.0. Toxicities will be summarized by maximum grade. Kaplan-Meier product-limit estimates and 90% confidence bands
- Patient Reported Outcomes by MDASI-BT [ Time Frame: 2 years ]Evaluated by M.D. Anderson Symptom Inventory Brain Tumor (MDASI-BT)
- Patient Reported Outcomes by EQ-5D [ Time Frame: 2 years ]Evaluated by EQ-5D evaluations assessments
- Investigator-Assessed Neurological Evaluation [ Time Frame: 2 years ]Evaluated by physician assessed Neurological Assessment in Neuro-Oncology (NANO) scale
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): NCT03417544
|Contact: Nancy Lin, MDfirstname.lastname@example.org|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Priya Kumthekar, MD Priya.Kumthekar@nm.org|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Nancy Lin, MD 617-632-3800 email@example.com|
|Contact: Kelly Silvestri 617-632-2403 KellyM_Silvestri@DFCI.HARVARD.EDU|
|Principal Investigator: Nancy Lin, MD|
|Principal Investigator:||Nancy Lin, MD||Dana-Farber Cancer Institute|