PER-059-09
Completed
未知
A Randomized Open-Label, Phase II Study of Lapatinib-capecitabine or Lapatinib-vinorelbine or Lapatinib/Gemcitabine in Subjects With Her2/Neu Amplified Metastatic Breast Cancer Patients Progression After Taxanes Treatment
Grupo Latinoamericano de Investigaciones Clinicas en Oncologica (GLICO),0 sites0 target enrollmentNovember 6, 2009
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- -C50 Malignant neoplasm of breast
- Sponsor
- Grupo Latinoamericano de Investigaciones Clinicas en Oncologica (GLICO),
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The signed informed consent must be obtained in accordance with the requirements of the ethics committee.
- •Subjects must be over 18 years.
- •Histologically confirmed invasive adenocarcinoma of the breast with metastatic or locally advanced disease defined as stage IIIb, lile stage with T4 lesion, or stage IV \[according to the 6th AJCC edition].
- •Documented progression after taxane\-based treatment for patients with ErbB2 positive metastatic breast cancer for first\-line or locally advanced or documented progression after taxane\-based regimens as adjuvant therapy. Patients may have had a maximum prior treatment with a chemotherapy regimen for metastatic disease.
- •Patients must have at least 1 definite lesion measurable by RECIST as follows: X\-ray, physical examination\> 20 mm, Conventional CT scan\> 20 mm, Spiral CT scan\> 10 mm. Measurable lesions should be outside the field of prior radiotherapy if they are in one place of disease.
- •Disease with over\-expression and / or amplification of HER2 / neu confirmed in the local laboratory in the invasive component of the primary or metastatic lesion
- •Previous therapy should include taxane regime.
- •In regions where trastuzumab is available without access barriers, patients must also have received trastuzumab alone or in combination with chemotherapy
- •Previous treatment with anthracyclines in adjuvant / neoadjuvant or metastatic first\-line scenarios is allowed if therapy has been discontinued at least 4 weeks before randomization, and all adverse events related to treatment are • Prior treatment with endocrine therapy is allowed if the therapy has been discontinued before randomization, and all adverse events related to treatment are • Previous treatments with radiotherapy for palliative management of metastatic disease, to a limited area (eg, palliative treatment for painful disease) at a different site than the measurable disease and the disease evaluated, it is allowed, however, the subjects must have Treatment completed at least 4 weeks after the last dose of radiotherapy prior to starting the study drugs, and must have recovered from treatment\-related toxicities before day 1\.11\. The life expectancy is at least 6 months.
- •ECOGPSO\-2\.
Exclusion Criteria
- •Pregnant or nursing women.
- •Previous therapy with another antiErbb1 or antiErbB2 white agent instead of Trastuzumab only limited by the treatment of V line of metastatic or locally advanced disease OR as adjuvant therapy.
- •Previous exposure to gemcitabine, Vinorelbine and capecitabine for treatment of 1st line of metastatic\-recurrent disease OR as adjuvant / neoadjuvant therapy.
- •Treatment in the 14 days prior to randomization with anti\-cancer therapy (tumor embolization, chemotherapy, immunotherapy, biological therapy, or hormonal therapy) or mitomycin treatment in the 6 weeks prior to randomization. Such treatment may or may not be resumed after admission to the study. Note: Patients receiving bisphosphonate therapy prior to randomization may continue during their participation in the study, however, bisphosphonates should be initiated following study entry. Prophylactic use of bisphosphonates in subjects without bone disease is not allowed, except for the treatment of osteoporosis.
- •Metastasis in active CNS.
- •Uncontrolled intercurrent disease including, but not limited to, an infection at that time or active, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, serious wound / ulcer / bone fracture that is not cured, or social situations / psychiatric illnesses that may limit the study requirements.
- •Patients with Gi tract disease who are unable to take oral medication, malabsorption syndrome, require EV feeding, previous surgical procedures that affect absorption, uncontrolled inflammatory GI disease (eg, Crohn, ulcerative colitis).
- •Have active liver or biliary disease (with the exception of patients with Gilbert´s syndrome, asymptomatic gallbladder stones, liver metastases or chronic stable liver disease in the investigator´s evaluation).
- •History of another cancer. Subjects who have been disease free for 5 years, or subjects with a history of skin cancer without completely resected melanoma or successfully treated carcinoma in situ are eligible.
- •Dementia, altered mental state, or any physical condition that could prohibit the understanding or signing of informed consent.
Outcomes
Primary Outcomes
Not specified
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