Conditions: Neoplasms, Breast
Keywords: Neoadjuvant Breast Cancer Pazopanib (GW786034) NSABP Foundation, Inc. cyclophosphamide Paclitaxel Doxorubicin
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 101
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether the treatment of a doxorubicin in combination with cyclophosphamide followed by a combination of pazopanib in combination with paclitaxel prior to surgery results in a pathological complete response in females with breast cancer.

Detailed description:
This is a phase II non-randomized, multi-center study aimed to evaluate the efficacy and safety of the combination of pazopanib and paclitaxel following treatment with cyclophosphamide and doxorubicin for the treatment of neoadjuvant breast cancer.

Patients will receive standard doses of AC every 21 days for 4 cycles. This will be followed by weekly paclitaxel 80 mg/m2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with pazopanib 800 mg PO daily starting with the first paclitaxel dose and continuing until 7 days before surgery. Clinical complete response rate will be determined by tumor assessments performed by palpation at two time points: following AC (before paclitaxel/pazopanib begins) and 2-4 weeks following the last dose of paclitaxel (before surgery). Following recovery from preoperative therapy, patients will undergo the clinically-indicated surgery. Pazopanib will resume 4-6 weeks after surgery and continue daily for 6 months of postoperative pazopanib therapy.

Arms:
arm 1: Preoperative

Cycles 1-4 Doxorubicin 60 mg/m2 IV over 15 minutes + Cyclophosphamide 600 mg/m2 IV over 30 minutes of Day 1 every 21 days

followed by:

Cycles 5-8 Paclitaxel 80 mg/m2 IV over 60 minutes (Days 1, 8, and 15) every 28 days in combination with pazopanib (800 mg) PO once daily (2 tablets taken at the same time each day either 1 hour before or 2 hours after a meal) Daily beginning on Day 1 of the first paclitaxel cycle Until 7 days before surgery

Followed by Surgery

Postoperative Pazopanib 800 mg PO once daily (2 tablets taken at the same time each day either 1 hour before or 2 hours after a meal) Daily beginning 4-6 weeks after surgery 6 months from first postoperative dose

Interventions: intervention 1: doxorubicin + cyclophosphamide intervention 2: paclitaxel + pazopanib intervention 3: surgery intervention 4: pazopanib monotherapy
Intervention descriptions: intervention 1: 4 cycles of doxorubicin + cyclophosphamide followed by 4 cycles of paclitaxel + pazopanib. intervention 2: 4 cycles of paclitaxel + pazopanib intervention 3: neoadjuvant surgery for breast cancer intervention 4: 6 months of treatment with pazopanib monotherapy

Protocol document: