Trastuzumab or Observation After Combination Chemotherapy and Trastuzumab in Treating Patients Undergoing Surgery for Stage II or Stage III Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00533936|
Recruitment Status : Unknown
Verified March 2008 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : September 24, 2007
Last Update Posted : August 26, 2013
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy together with trastuzumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving trastuzumab after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether trastuzumab is more effective than observation when given after combination chemotherapy and trastuzumab in treating patients with breast cancer.
PURPOSE: This randomized phase II trial is studying trastuzumab to see how well it works compared with observation when given after combination chemotherapy and trastuzumab in treating patients undergoing surgery for stage II or stage III breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: trastuzumab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: fluorouracil Drug: paclitaxel Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Masking:||None (Open Label)|
|Official Title:||Adjuvant Trastuzumab vs Observation in Locally Advanced Breast Cancer Treated With Neoadjuvant Trastuzumab|
|Study Start Date :||September 2006|
|Estimated Primary Completion Date :||December 2009|
- Percentage of pathological responses
- Disease-free survival
- Overall survival at 3 years
- Cardiac toxicity
- Percentage of patients that become negative on the fluorescence in situ hybridization (FISH) test at the end of neoadjuvant therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00533936
|Instituto Nacional de Cancerologia||Recruiting|
|Mexico City, Distrito Federal, Mexico, 14000|
|Contact: Claudia Arce-Salinas, MD 52-55-5628-0400|
|Hospital General de Mexico||Recruiting|
|Mexico City, Distrito Federal, Mexico, C.P. 06726|
|Contact: Contact Person 52-55-5999-6133|
|Principal Investigator:||Claudia Arce-Salinas, MD||Instituto Nacional de Cancerologia, Columbia|