Trial Using Docetaxel Cytoxan in Breast Cancers With High Recurrence Scores
|Breast Neoplasms Breast Cancer Cancer of the Breast||Drug: Docetaxel with Cytoxan Drug: Dexamethasone||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
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 after surgery ]
Patients were assessed for surgery after 6 cycles of TC (18 weeks). The primary method of response determination was clinical examination, but mammography, breast ultrasound and breast MRI were also used to confirm response or non-response at the discretion of the investigator. Response determination was gauged as follows:
- Clinical: as per investigator, if breast mass was larger after treatment, patient was considered upstaged (worse outcome); if stable, downstaged; and if smaller/less extensive, downstaged (better outcome).
- Radiographic: analyzed by breast radiologist who looked at preoperative/postoperative imaging. Similarly, if breast mass was larger after treatment, patient was considered upstaged; if stable, downstaged; and if smaller/less extensive, downstaged.
- Pathologic: if pathologic stage was the same as clinical stage, patient was stable; if higher, upstaged; if lower, downstaged. Pathologic stage was determined by Emory board-certified pathologists.
|Study Start Date:||April 2009|
|Study Completion Date:||October 2015|
|Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Experimental: Docetaxel with Cytoxan
Patients will be treated with docetaxel at 75 mg/m² concomitantly with cytoxan 600 mg/m² (TC) IV D1 every 3 weeks for 6 cycles. Due to known toxicity of docetaxel, all patients require dexamethasone 4 mg twice daily (BID) PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.
Drug: Docetaxel with Cytoxan
Docetaxel 75 mg/m² plus cytoxan 600 mg/m² every 3 weeks for 6 cycles.
Other Names:Drug: Dexamethasone
Dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel.
Other Name: Decadron
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832338
|United States, Georgia|
|Grady Memorial Hospital|
|Atlanta, Georgia, United States, 30303|
|Emory University Hospital Midtown|
|Atlanta, Georgia, United States, 30308|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Elisavet Paplomata, MD||Emory University Winship Cancer Institute|