Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/24/2018 |
| Start Date: | August 21, 2009 |
| End Date: | June 28, 2018 |
A Randomized, Open-Label, Two-Arm Study Of Neratinib Plus Paclitaxel Versus Trastuzumab Plus Paclitaxel As First-Line Treatment For ErbB-2-Positive Locally Recurrent Or Metastatic Breast Cancer
This study is investigating the effects of an experimental drug (neratinib) in combination
with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women
who have not received previous treatment for erbB-2-positive locally recurrent or metastatic
breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors
and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will
also compare the safety of the two regimens and as well as the quality of life of subjects
receiving either regimen.
with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women
who have not received previous treatment for erbB-2-positive locally recurrent or metastatic
breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors
and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will
also compare the safety of the two regimens and as well as the quality of life of subjects
receiving either regimen.
Inclusion Criteria:
- ErbB-2 positive locally recurrent or metastatic breast cancer
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Measurable disease
- Availability of tumor tissue for HER2 status confirmation
Exclusion Criteria:
- Prior systemic anti-cancer therapy other than endocrine therapy for locally recurrent
or metastatic disease
- Prior erbB-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or
adjuvant setting
- Progression/recurrence within 12 months after completion of adjuvant or neoadjuvant
therapy
- History of heart disease
- History of gastrointestinal disease
We found this trial at
37
sites
1 Valley Health Plz
Paramus, New Jersey 07652
Paramus, New Jersey 07652
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2320 S Seacrest Blvd # 300
Boynton Beach, Florida 33435
Boynton Beach, Florida 33435
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1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
Port Saint Lucie, Florida 34952
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Charleston, West Virginia 25304
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