Conditions: Breast Cancer
Keywords: newly diagnosed breast cancer neoadjuvant therapy
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 23
Healthy volunteers: no

Brief summary:
The combination of paclitaxel, doxorubicin, and cyclophosphamide is a standard neoadjuvant (given before surgery) treatment for patients that have either inoperable or operable breast cancer. This treatment can help shrink the tumors so they can be removed to help prevent the cancer from spreading to other parts of the body. This study is being done to test the impact of adding sunitinib as a single-agent (Segment 1), followed by sunitinib plus paclitaxel (Segment 2), followed by doxorubicin and cyclophosphamide (Segment 3). We hope the addition of sunitinib will make the treatment more effective, but we don't know if this is true.

Detailed description:

Arms:
arm 1: The study will be conducted in 3 sequential treatment segments.

Interventions: intervention 1: sunitinib alone intervention 2: sunitinib plus paclitaxel intervention 3: doxorubicin and cyclophosphamide
Intervention descriptions: intervention 1: sunitinib alone (segment 1): During the first segment, patients will receive single-agent sunitinib for 2 weeks. intervention 2: sunitinib plus paclitaxel (Segment 2): Following Segment 1, patients will begin the second segment, 4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel. intervention 3: doxorubicin and cyclophosphamide (Segment 3): Following Segment 2, patients will receive 4 cycles (8 weeks) of neoadjuvant treatment with AC.

Protocol document: