Exemestane or Docetaxel-Cytoxan in Low Recurrence Score Cancers
The patients are being asked to take part in this study because they have a hormone receptor-positive breast cancer (contains estrogen and/or progesterone receptors) and their doctor has told them that they have an option to receive chemotherapy or hormonal therapy before surgery. The purpose of this study is to assess if chemotherapy using docetaxel and cytoxan (TC) or hormonal therapy using exemestane can shrink the size of their breast tumor and allow them to preserve the breast or have less extensive surgery on their breast.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Phase II Trial of Pre-Operative Docetaxel-Cytoxan (TC) or Exemestane in Patients With Hormone Receptor-Positive Breast Cancers With Recurrence Scores Greater Than 10 (≥ 11) and Less Than 25 (≤ 24)|
- Pathologic complete response. [ Time Frame: After surgery ] [ Designated as safety issue: No ]
- Clinical response rate, response rate by imaging, correlative studies [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Experimental: A: Exemestane
ARM A: Patients will be treated with exemestane.
25 mg daily by mouth for 6 to 12 months
Active Comparator: B: Docetaxel and Cytoxan
ARM B: Patients will be treated with docetaxel and cytoxan.
Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
Other Name: TaxotereDrug: Cytoxan
Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
Other Name: Cyclophosphamide
The purpose of this study is to assess if chemotherapy using docetaxel and cytoxan (TC) or hormonal therapy using exemestane 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 or hormonal therapy before surgery, we will be able to determine if the treatment you receive is effective in treating your cancer. 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 and hormonal therapy. You will only be eligible to enter this study if the recurrence score of your cancer determined using the Oncotype DX assay is less than or equal to 24. Patients with hormone receptor-positive breast cancers with recurrence scores less than or equal to 24 have been previously demonstrated to obtain a larger benefit from hormonal therapy, compared to chemotherapy, when these agents are given after surgery. The ability of hormonal agents and chemotherapy to shrink cancers prior to surgery has not been specifically examined in hormone receptor-positive cancers with recurrence scores less than or equal to 24.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941330
|United States, Georgia|
|Emory University Hospital Midtown|
|Atlanta, Georgia, United States, 30308|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Grady Memorial Hospital|
|Atlanta, Georgia, United States, 30303|
|Principal Investigator:||Elisavet Paplomata, MD||Emory University Winship Cancer Institute|