Phase II Trial of Pertuzumab plus Trastuzumab plus Docetaxel for HER2-Positive Metastatic Breast Cancer that Progressed During Prior Trastuzumab Therapy
- Conditions
- HER2-Positive Metastatic Breast Cancer
- Registration Number
- JPRN-UMIN000012452
- Lead Sponsor
- Chiba Youth Breast Oncology Research Group (CYBORG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 35
Not provided
1. Patients who have an active infection or high fever with suspicious infection. 2. Patients who have a history of cardiac disease, including known symptomatic decreases in LVEF to less than 50% absolute value during prior trastuzumab therapy or congestive heart failure. 3. Patients with pulmonary fibrosis or interstitial pneumonia that is clear from the chest X-ray 4. Patients with previous exposure to a cumulative dose of doxorubicin of more than 360 mg/m2 5. Patients with a decline in LVEF to less than 50% during or after former trastuzumab treatment 6. Patients suspected of being pregnant or pregnant women 7. Patients with another malignancy within the last 5 years 8. Patients with uncontrollable brain metastases 9. Patients who were considered by the primary care physician to be inappropriate as subjects of this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate
- Secondary Outcome Measures
Name Time Method Progression free survival Clinical benefit rate Overall survival Safety