Description:
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.
Title
- Brief Title: Gemcitabine, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer After Prior Trastuzumab/Pertuzumab, or Pertuzumab Based Therapy
- Official Title: Phase II Study of Gemcitabine, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer After Prior Trastuzumab/Pertuzumab- or Pertuzumab-Based Therapy
Clinical Trial IDs
- ORG STUDY ID:
14-124
- NCT ID:
NCT02252887
Conditions
- Metastatic HER2-Positive Breast Cancer
Interventions
Drug | Synonyms | Arms |
---|
Gemcitabine | | Gemcitabine, Trastuzumab, and Pertuzuma |
Trastuzumab | | Gemcitabine, Trastuzumab, and Pertuzuma |
Pertuzumab | | Gemcitabine, Trastuzumab, and Pertuzuma |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Gemcitabine, Trastuzumab, and Pertuzuma | Experimental | The regimen will consist of gemcitabine at 1000mg/m^2 IV weekly days 1 + 8 q 3 weeks + trastuzumab every 3 weeks (8 mg/kg loading dose followed by 6 mg/kg every 3 weeks) + pertuzumab every 3 weeks (840 mg as a loading dose followed by 420 mg every 3 weeks), all given intravenously (IV). Trastuzumab may be given IV weekly (4 mg/kg loading dose followed by 2 mg/kg weekly) in lieu of the every 3 week schedule. A loading dose of trastuzumab will not be required for patients who have received it < 6 weeks prior to Cycle 1 Day 1. | - Gemcitabine
- Trastuzumab
- Pertuzumab
|
Eligibility Criteria
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | progression free |
Time Frame: | 3 months |
Safety Issue: | |
Description: | 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 Outcome Measures
Measure: | progression-free survival |
Time Frame: | 2 years |
Safety Issue: | |
Description: | Progression-free survival (PFS) is defined from time from treatment assignment to disease progression or death, whichever comes first. |
Measure: | response |
Time Frame: | 2 years |
Safety Issue: | |
Description: | Response to treatment will be determined using both RECIST and PRC ( PET Response Criteria criteria). |
Measure: | overall survival |
Time Frame: | 2 years |
Safety Issue: | |
Description: | Progression-free survival and median overall survival will also be estimated by the Kaplan-Meier method. |
Measure: | safety |
Time Frame: | 2 years |
Safety Issue: | |
Description: | This study will use the NCI Common Toxicity Criteria (CTC) AE version 4.0 for toxicity. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Memorial Sloan Kettering Cancer Center |
Trial Keywords
- Gemcitabine,
- Trastuzumab
- Pertuzumab
- 14-124
Last Updated
February 24, 2021