The purpose of this study is to see if a combination of drugs can help to treat breast cancer. This is a Phase II study which will test whether this combination of drugs is effective and will provide further information on side effects and safety. A standard chemotherapy, gemcitabine, will be combined with 2 other drugs that target the HER2 receptor. The HER2 receptor is a growth protein on the surface of some breast cancer cells that provides messages telling the breast cancer cell to grow. The standard chemotherapy will be gemcitabine.. The other two drugs work against HER2. One is called trastuzumab (Herceptin) and it is commonly given to women with advanced and early HER2 positive breast cancer. The other drug, pertuzumab (Perjeta), is also given to women with advanced HER2 positive breast cancer. The drugs in this study are each individually approved for the treatment of metastatic breast cancer. However, this study is looking at the effectiveness of gemcitabine with trastuzumab and pertuzumab when given to women who have advanced HER2 positive breast cancer who have had prior trastuzumab + pertuzumab or pertuzumab-based therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Hartford Healthcare Cancer Institute @ Hartford Hospital
Hartford, Connecticut, United States
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Progression Free
Progression-free survival (PFS) is defined from time from treatment assignment to disease progression or death, whichever comes first. The primary endpoint is PFS and secondary endpoint will include the response rate using the RECIST criteria (version 1.1).
Time frame: 3 months
Progression-free Survival
Progression-free survival (PFS) is defined from time from treatment assignment to disease progression or death, whichever comes first.
Time frame: 2 years
Response
Response to treatment will be determined using both RECIST and PRC ( PET Response Criteria criteria).
Time frame: 3 months
Overall Survival
Progression-free survival and median overall survival will also be estimated by the Kaplan-Meier method.
Time frame: 3 months
Number of Participants With Grade 3+ Adverse Events
This study will use the NCI Common Toxicity Criteria (CTC) AE version 4.0 for toxicity. Grade 3 or higher AEs
Time frame: 2 years
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