Phase II Trial of Neoadjuvant Chemotherapy [NCT] With Weekly Nanoparticle Albumin-bound Paclitaxel [Nab-paclitaxel; Abraxane®] in Combination With Carboplatin and Bevacizumab in Women With Clinical Stages I-III Breast Cancer
- To determine the complete pathological response (pCR) in the breast/axillary lymph
nodes in women with stage II or III breast cancer treated with neoadjuvant therapy
comprising paclitaxel albumin-stabilized nanoparticle formulation, carboplatin, and
bevacizumab followed by surgery and adjuvant bevacizumab.
- To determine the side effects of this regimen in these patients.
- To evaluate dynamic contrast-enhanced magnetic resonance imaging in assessing pCR.
- To measure LZTS1 gene expression before and after neoadjuvant therapy to evaluate
whether LZTS1 gene expression correlates with pCR.
- To evaluate the feasibility and toxicity of adjuvant bevacizumab when administered for
- Neoadjuvant therapy: Patients receive paclitaxel albumin-stabilized nanoparticle
formulation IV over 30 minutes and carboplatin IV over 30 minutes on days 1, 8, and 15
and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days
for 5 courses. After completion of course 5, patients receive paclitaxel
albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over
30 minutes on days 1, 8, and 15. Patients then proceed to surgery.
- Surgery: Approximately 4-5 weeks after completion of neoadjuvant therapy, patients
undergo definitive surgery (either lumpectomy or mastectomy). Patients with
node-positive disease or inflammatory breast cancer at baseline also undergo axillary
lymph node dissection. Patients then proceed to adjuvant therapy.
- Adjuvant therapy: Beginning approximately 6 weeks after surgery, patients receive
bevacizumab IV over 30-90 minutes once every 3 weeks for 6 months. Patients with
hormone receptor-positive disease also receive endocrine therapy. Patients may also
receive additional adjuvant chemotherapy or radiotherapy at the discretion of the
Patients undergo dynamic contrast-enhanced magnetic resonance imaging at baseline, after
course 2 of neoadjuvant therapy, and after completion of neoadjuvant therapy (prior to
definitive surgery) for assessment of tumor response. Tumor tissue is collected at baseline
and during surgery for correlative laboratory studies. LZST1 gene expression is assessed by
immunohistochemistry before and after neoadjuvant therapy.
Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathologic complete response (pCR) and side effects of weekly nab-paclitaxel, carboplatin and bevacizumab.
every 4 weeks
Ewa Mrozek, MD
Ohio State University
United States: Food and Drug Administration
|Ohio State University Medical Center||Columbus, Ohio 43210|