Status:
COMPLETED
Trastuzumab and Pertuzumab in Treating Patients With Unresectable Locally Advanced or Metastatic Breast Cancer That Did Not Respond to Previous Trastuzumab
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as trastuzumab and pertuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and he...
Detailed Description
OBJECTIVES: Primary * Determine the objective response rate in patients with HER2/neu-overexpressing, inoperable locally advanced or metastatic breast cancer refractory to trastuzumab (Herceptin®)-b...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed invasive breast cancer of 1 of the following stages:
- Metastatic disease (stage IV)
- Inoperable locally advanced disease
- Disease progression after prior neoadjuvant chemotherapy required
- Disease progression on or after trastuzumab (Herceptin®) based-therapy
- Received 1-3 prior trastuzumab-based regimens
- HER2/neu-positive tumor, defined as 3+ by fluorescent in situ hybridization
- Measurable disease, defined as at least 1 lesion that can be measured in at least one dimension
- No clinical signs or symptoms of brain and/or leptomeningeal metastases confirmed by CT scan or MRI
- Brain and/or leptomeningeal metastases allowed if patient has stable lesions after standard treatment (surgery or radiotherapy), is asymptomatic on neurological exam, and is not receiving corticosteroid therapy to control symptoms
- Hormone receptor status:
- Not specified
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Male or female
- Menopausal status not specified
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 75,000/mm\^3
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- Alkaline phosphatase \< 5 times ULN
- AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
- LVEF above lower limit of normal by echocardiogram or MRI
- No clinical signs or symptoms of heart failure
- No uncontrolled hypertension (i.e., blood pressure ≥ 180/100 mm Hg)
- No significant valvular disease (i.e., aortic or mitral regurgitation of 3 or 4+/4+ severity or stenosis of either valve)
- No history of uncontrolled cardiac arrhythmia
- No symptomatic or asymptomatic myocardial infarction
- No angina pectoris requiring medication
- No other documented significant cardiac event
- No poorly controlled diabetes mellitus (i.e., fasting blood sugar ≥ 200 mg/dL)
- No history of hypersensitivity reaction to trastuzumab
- No AIDS
- No nonmalignant condition requiring ≥ 20 mg of prednisone (or equivalent)
- No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
- No ongoing liver disease, including viral or other hepatitis, alcohol abuse, or cirrhosis
- No other serious medical illness
- No medical or psychiatric condition that would preclude study participation
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior therapy
- More than 3 weeks since prior investigational anticancer agents
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C), major surgery, or immunotherapy
- More than 4 weeks since prior radiotherapy except short-course palliative radiotherapy for bone pain
- More than 2 weeks since prior and no concurrent oral hormonal therapy
- More than 4 weeks since prior fulvestrant
- No prior doxorubicin hydrochloride or doxorubicin HCl liposome at a cumulative dose of \> 360 mg/m\^2
- No prior mitoxantrone hydrochloride at a cumulative dose of \> 120 mg/m\^2
- No prior epirubicin hydrochloride at a cumulative dose of \> 600 mg/m\^2
- No prior idarubicin at a cumulative dose of \> 90 mg/m\^2
- No concurrent radiation therapy, including for symptomatic bone metastases
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2007
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00301899
Start Date
December 1 2005
End Date
October 1 2007
Last Update
March 8 2012
Active Locations (1)
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1
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182