Conditions: Breast Cancer
Keywords: invasive breast cancer HER2 primary breast cancer neo-adjuvant therapy Trastuzumab Nab-paclitaxel
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 32
Healthy volunteers: no

Brief summary:
The purpose of this study is to find out if there is a benefit of adding Herceptin (trastuzumab) to standard chemotherapy in this type of breast cancer.

Detailed description:
Neoadjuvant (primary) chemotherapy refers to chemotherapy given before surgery. Neoadjuvant chemotherapy has a number of potential advantages including increasing the chances for breast preservation at the time of surgery as well as it may improve the local control of the cancer. Several national breast cancer studies have shown that neoadjuvant chemotherapy was equal to chemotherapy given following surgery.

A standard treatment for stage II or Stage III invasive breast cancer with low HER2 expression is combination chemotherapyAdriamycin, Cytoxan,followed by a Taxane: given either before or after surgery), followed by surgery +/- radiation therapy.

The main purpose of chemotherapy however is to reduce the risk of recurrence of cancer and also make surgery more successful. HER2 is a receptor located on the surface of some cells. This receptor plays a role in regulating the growth of the cell, in addition to the growth of tumors. High levels of the HER2 receptor may predict those women who benefit from treatment with agents such as Herceptin that target HER2. Herceptin (Trastuzumab) is a drug that is effective both alone and in combination with standard chemotherapy. There is some data to suggest that patients whose tumors have low expression of the HER2 protein and are normal by FISH may also receive benefit from Herceptin.

Arms:
arm 1: Nab-paclitaxel, trastuzumab, doxorubicin, cyclophosphamide, Growth Factor Support, Surgery

Interventions: intervention 1: nab-paclitaxel intervention 2: trastuzumab intervention 3: Doxorubicin intervention 4: cyclophosphamide intervention 5: Growth Factor Support intervention 6: Surgery
Intervention descriptions: intervention 1: 100 MG/M2 IV over 30 minutes once a week for 12 weeks intervention 2: 4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks intervention 3: 60 MG/M2 every two weeks for a total of 4 cycles intervention 4: 600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above) intervention 5: * All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle.
* Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician. intervention 6: * After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy.
* All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection.

Protocol document: