Evaluate Trastuzumab Plus Standard Chemotherapy Given Before Surgery in Breast Cancer Patients With Low HER 2 Expression
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Abraxane and Trastuzumab Followed by Dose Dense Doxorubicin and Cyclophosphamide as Neoadjuvant Therapy in Invasive Breast Cancer With Low HER2 Expression (1+ or 2+ by IHC)|
- Pathologic Complete Response [ Time Frame: 22 weeks ] [ Designated as safety issue: Yes ]
- Assessment of cardiac safety by comparing left ventricular ejection fraction by echocardiogram from baseline to completion of treatment and assessment of reduction in primary tumor size response after first two cycles of chemotherapy with pCR rate. [ Time Frame: 22 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2009|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Nab-paclitaxel, trastuzumab, doxorubicin, cyclophosphamide
100 MG/M2 IV over 30 minutes once a week for 12 weeks
Other Name: AbraxaneDrug: trastuzumab
4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks
Other Name: HerceptinDrug: Doxorubicin
60 MG/M2 every two weeks for a total of 4 cycles
Other Name: AdriamycinDrug: cyclophosphamide
600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)
Other Name: Cytoxan
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944047
|United States, Kansas|
|Hays Medical Center|
|Hays, Kansas, United States, 67601|
|University of Kansas Medical Center Cancer Center|
|Kansas City, Kansas, United States, 66205|
|Principal Investigator:||Qamar Khan, MD||University of Kansas Medical Center Cancer Center|