Trial Using Docetaxel Cytoxan in Breast Cancers With High Recurrence Scores
The purpose of this study is to assess if docetaxel and cytoxan can shrink the size of your breast tumor and allow you to preserve your breast or have less extensive surgery on your breast. Additionally, by receiving chemotherapy before surgery, the investigators will be able to determine if your cancer is responsive to chemotherapy.
Cancer of the Breast
Drug: Docetaxel and Cytoxan
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Pre-Operative Docetaxel-Cytoxan (TC) in Patients With Hormone Receptor-Positive Cancers With Recurrence Scores ≥ 25|
- Response to pre-operative docetaxel and Cytoxan (TC) [ Time Frame: approximately 18 weeks ] [ Designated as safety issue: Yes ]
Patients will be assessed for surgery after 6 cycles of TC (18 weeks).
The primary method of response determination will be by clinical examination, but mammography, breast ultrasound and breast MRI can be used to confirm response or non-response at the discretion of the investigator.
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Experimental: Docetaxel with Cytoxan
Patients will be treated with docetaxel at 75mg/m2 concomitantly with cytoxan 600 mg/m2 (TC) IV D1 every 3 weeks for 6 cycles
Drug: Docetaxel and Cytoxan
Docetaxel 75mg/m2 plus cytoxan 600mg/m2 every 3 weeks for 6 cycles
Other Names:Drug: Dexamethasone
Due to known toxicity of docetaxel, all patients require dexamethasone 4mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.
Previous studies have shown that chemotherapy has the same effect on treating breast cancer whether you receive it before or after surgery. Receiving chemotherapy before surgery, rather than after surgery, may allow you to have less extensive surgery by shrinking the size of your cancer. The purpose of this study is to assess if docetaxel and cytoxan can shrink the size of your breast tumor and allow you to preserve your breast or have less extensive surgery on your breast. Additionally, by receiving chemotherapy before surgery, we will be able to determine if your cancer is responsive to chemotherapy. Prior to entering this study, a special test, called the Oncotype DX assay, will be performed on a small amount of your cancer from the biopsy you had at the time you were diagnosed with breast cancer, to determine the likelihood that your cancer will benefit from and shrink with chemotherapy. You will only be eligible to enter this study if the recurrence score determined using the Oncotype DX assay is 25 or greater. Patients with hormone receptor-positive breast cancers with recurrence scores greater than or equal to 25 have been previously demonstrated to obtain a significant benefit from chemotherapy given after surgery.
In addition, researchers would like to examine proteins present in your blood and proteins present in your breast tissue. These additional parts of the study are voluntary and are NOT required to participate in this study. This consent form will describe these parts of the study later, in Addendums I and II.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832338
|Contact: Amelia Zelnak, MDfirstname.lastname@example.org|
|United States, Georgia|
|Emory University Winship Cancer Institute||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator: Ruth O'Regan, MD|
|Principal Investigator:||Amelia Zelnak, MD||Emory University Winship Cancer Institute|