A Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer
Status: | Completed |
---|---|
Conditions: | Breast Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | August 2011 |
End Date: | June 2014 |
A Randomized, Phase 2 Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer
To demonstrate whether addition of MM-121 to paclitaxel is more effective than treatment
with paclitaxel alone, when administered as part of the neoadjuvant treatment in Her2
negative locally advanced operable breast cancer patients.
with paclitaxel alone, when administered as part of the neoadjuvant treatment in Her2
negative locally advanced operable breast cancer patients.
This is a multicenter, open-label, randomized, Phase II study of preoperative MM-121 with
paclitaxel in HER2-negative breast cancer. Patients will be randomized to receive paclitaxel
with or without MM-121 for 12 weeks followed by 4 cycles of doxorubicin plus
cyclophosphamide and subsequent surgery.
paclitaxel in HER2-negative breast cancer. Patients will be randomized to receive paclitaxel
with or without MM-121 for 12 weeks followed by 4 cycles of doxorubicin plus
cyclophosphamide and subsequent surgery.
Inclusion Criteria:
- Histological confirmation of ER positive, HER2 negative invasive breast cancer (Group
1) or invasive triple-negative breast cancer (Group 2)
- Free of metastatic disease
- ≥ 18 years old
- Female
- Had no prior treatment for any cancer
- Eligible for treatment with paclitaxel, doxorubicin and cyclophosphamide
Exclusion Criteria:
- Have a history of severe allergic reactions to paclitaxel or other drugs formulated
in Cremaphor® EL
- Are pregnant or breastfeeding
We found this trial at
37
sites
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Piedmont Fayette Hospital Piedmont Fayette Hospital, a 172-bed community hospital, is among the most highly-ranked...
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Cancer Care Centers of South Texas At Cancer Care Centers of South Texas, we are...
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