Clinical Trial: NCT01026142
A Study of a Combination of Trastuzumab and Capecitabine With or Without Pertuzumab in Patients With HER2-positive Metastatic Breast Cancer (PHEREXA)
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Hoffmann-La Roche |
| Information Provided By: | Hoffmann-La Roche |
| Last Update Posted: | 2018-08-14 |
Study Overview
Brief Summary
This randomized, two-arm study evaluated the efficacy and safety of a combination of trastuzumab and capecitabine with or without pertuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. The study population consisted of female patients, whose disease had progressed during or following previous trastuzumab therapy for metastatic disease. All patients in Arm A and Arm B received trastuzumab (8 mg/kg iv as loading dose and then 6 mg/kg iv every 3 weeks thereafter) and capecitabine oral twice daily for 14 days every 3 weeks (1250 mg/m2 twice daily in Arm A and 1000 mg/m2 twice daily in Arm B). In addition, patients in Arm B received pertuzumab (840 mg iv as loading dose and then 420 mg iv thereafter) every 3 weeks. Study treatment continued until disease progression or unacceptable toxicity.
Official Title
Conditions
Intervention / Treatment
- Drug: Capecitabine
- Drug: Capecitabine
- Drug: Pertuzumab
- Drug: Trastuzumab
Other Study ID Numbers
- MO22324
- 2008-006801-17
- 2008
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Hoffmann-La Roche |
| Information Provided By: | Hoffmann-La Roche |
| Last Update Posted: | 2018-08-14 |
Study Overview
Brief Summary
This randomized, two-arm study evaluated the efficacy and safety of a combination of trastuzumab and capecitabine with or without pertuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. The study population consisted of female patients, whose disease had progressed during or following previous trastuzumab therapy for metastatic disease. All patients in Arm A and Arm B received trastuzumab (8 mg/kg iv as loading dose and then 6 mg/kg iv every 3 weeks thereafter) and capecitabine oral twice daily for 14 days every 3 weeks (1250 mg/m2 twice daily in Arm A and 1000 mg/m2 twice daily in Arm B). In addition, patients in Arm B received pertuzumab (840 mg iv as loading dose and then 420 mg iv thereafter) every 3 weeks. Study treatment continued until disease progression or unacceptable toxicity.
Official Title
Conditions
Intervention / Treatment
- Drug: Capecitabine
- Drug: Capecitabine
- Drug: Pertuzumab
- Drug: Trastuzumab
Other Study ID Numbers
- MO22324
- 2008-006801-17
- 2008