Study In Women And Men With Metastatic Breast Cancer That Have Overexpression Of ErbB2
- Conditions
- -C50 Malignant neoplasm of breastMalignant neoplasm of breastC50
- Registration Number
- PER-022-06
- Lead Sponsor
- GLAXOSMITHKLINE PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 18
1. Male or female ≥18 years.
2. Histologically confirmed invasive breast cancer with stage IV disease.
3. Documented amplification of ErbB2 by fluorescence in situ hybridization (FISH) in primary or metastatic tumor tissue.
4. If a taxane was administered in a neoadjuvant or adjuvant setting, the progression must have occurred> 12 months after completing this treatment and the patient recovering from all associated toxicities.
5. Measurable lesions according to RECIST.
6. Radiation therapy as a palliative treatment for painful metastatic disease is allowed but must have stopped within 2 weeks before starting any investigational treatment.
7. Patients with visceral disease requiring chemotherapy.
8. Disease that progresses rapidly or threatens life.
9. Patients who received hormone therapy and who are no longer benefiting from this therapy, and hormonal treatment must have stopped before the first dose of the investigational treatment.
10. Fraction of cardiac ejection within the normal institutional range as measured by an echocardiogram.
11. Stored tumor tissue available for testing.
12. Adequate function of the organs.
1. Women who are pregnant or breast-feeding at any time during the study.
2. They received chemotherapy, immunotherapy, biological therapy or previous anti-ErbBl / ErbB2 therapy for metastatic disease.
3. Previous therapy with an ErbBl and / or ErbB2 inhibitor, in addition to trastuzumab in a coadjuvant setting. If trastuzumab was administered in a coadjuvant setting, then the end of therapy with trastuzumab must have passed> 12 months later.
4. Serious toxicity unresolved or unstable from previous administration of another investigational drug and / or previous cancer treatment.
5. Peripheral neuropathy of Grade 2 or higher.
6. Known history of uncontrolled or symptomatic angina, arrhythmias or congestive heart failure.
7. Known history or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Evaluation of the disease / tumor measurements (CT, MRI, bone scan): Of the Complete Response (CR) defined as the disappearance of all white lesions. and of the Partial Response (RP), defined as a reduction of at least 30% in the sum of the largest diameter of the white lesions.<br>Measure:Benefit rate: Percentage of subjects who achieved a complete or partial response to the confirmed tumor or a stable disease for at least 24 weeks.<br>Timepoints:CT, MRI: Every 8 weeks, at the end of the treatment or withdrawal from the study and during the follow-up every 12 weeks.<br>Bone scan: Every 6 months, at the end of the treatment or withdrawal from the study and during the follow-up every 12 weeks.<br>
- Secondary Outcome Measures
Name Time Method