Metastatic HER2-Positive Breast Cancer
Conditions
Keywords
Gemcitabine,, Trastuzumab, Pertuzumab, 14-124
Brief summary
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.
Interventions
DRUGGemcitabine
DRUGTrastuzumab
DRUGPertuzumab
Sponsors
Memorial Sloan Kettering Cancer Center
Genentech, Inc.
Hoffmann-La Roche
Hartford HealthCare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ to 18 * Stage IV HER2 (+) breast cancer * Histologically documented HER2 (+) breast cancer as defined as IHC 3+ or FISH amplification of ≥ 2.0 of primary or metastatic site; results from the local lab are acceptable. * lECOG performance status 0 -1 * Prior treatment with trastuzumab + pertuzumab (HP)-based therapy or pertuzumab-based in the neoadjuvantadjuvant, unresectable, locally advanced, or metastatic setting. * ≤ 3 prior chemotherapies in the metastatic setting. Prior anthracycline, taxane, gemcitabine, and anti-HER2 agents (i.e. trastuzumab, pertuzumab, lapatinib, neratinib, TDM-1, etc.) are allowed. If patients received prior gemcitabine, it could not have been combined with pertuzumab. Patients should have progression of disease on current therapy. * Measurable or non-measurable disease. * LVEF ≥ 50% * Hematologic parameters: white blood cell (WBC) count of ≥ 3000/ul, absolute neutrophil count (ANC) ≥ 1000/ul, platelets ≥ 100,000/ul, hemoglobin ≥10.0 g/dl * Non-hematologic parameters: bilirubin ≤ 1.5 mg/dl, AST/ALT≤ 2.5 x upper limit of normal (ULN), alkaline phosphatase ≤ 5 x ULN. * Creatinine ≤ 1.5 mg/dl * Patients with "treated and stable" brain lesions of a duration of ≥ 2 months may be enrolled.
Exclusion criteria
* History of prior unstable angina, myocardial infarction, CHF, uncontrolled ventricular arrhythmias within 12 months * History of prior ≥ G 3 hypersensitivity (HSR) or any toxicity to trastuzumab or pertuzumab that warranted permanent cessation of this agent * History of hepatitis B or C * Pregnant patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free | 3 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | 2 years | Progression-free survival (PFS) is defined from time from treatment assignment to disease progression or death, whichever comes first. |
| Response | 3 months | Response to treatment will be determined using both RECIST and PRC ( PET Response Criteria criteria). |
| Overall Survival | 3 months | Progression-free survival and median overall survival will also be estimated by the Kaplan-Meier method. |
| Number of Participants With Grade 3+ Adverse Events | 2 years | This study will use the NCI Common Toxicity Criteria (CTC) AE version 4.0 for toxicity. Grade 3 or higher AEs |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChau Dang, MD
Memorial Sloan Kettering Cancer Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 57.1 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 32 Participants |
| Region of Enrollment United States | 45 Participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 20 / 45 |
| other Total, other adverse events | 45 / 45 |
| serious Total, serious adverse events | 8 / 45 |
Outcome results
None listed