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Sponsors and Collaborators: |
Emory University Sanofi-Aventis |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00832338 |
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.
Condition | Intervention | Phase |
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Breast Neoplasms Breast Cancer Cancer of the Breast |
Drug: Docetaxel and Cytoxan |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Trial of Pre-Operative Docetaxel-Cytoxan (TC) in Patients With Hormone Receptor-Positive Cancers With Recurrence Scores ≥ 25 |
Estimated Enrollment: | 40 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Baseline measurements of the indicator lesions must be recorded on the Patient Registration Form. To be valid for baseline, the measurements must have been made within the 14 days (28 days for x-rays and scans) immediately preceding patient's entry in study.
Adequate organ function within 14 days of study entry:
Exclusion Criteria:
Contact: Ruth O'Regan, MD | 1-88-946-7447 | ruth.oregan@emoryhealthcare.org |
United States, Georgia | |
Emory University Winship Cancer Institute | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Principal Investigator: Ruth O'Regan, MD |
Principal Investigator: | Ruth O'Regan, MD | Emory University Winship Cancer Institute |
Responsible Party: | Winship Cancer Institute ( Ruth O'Regan, MD ) |
Study ID Numbers: | WCI1505-08 |
Study First Received: | January 29, 2009 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00832338 History of Changes |
Health Authority: | United States: Institutional Review Board |
Breast cancer Tumors, Breast Cancer of the breast |
Docetaxel Immunologic Factors Skin Diseases Breast Neoplasms Antineoplastic Agents, Alkylating Cyclophosphamide |
Antirheumatic Agents Alkylating Agents Immunosuppressive Agents Hormones Breast Diseases Recurrence |
Molecular Mechanisms of Pharmacological Action Skin Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Cyclophosphamide Immunosuppressive Agents Pharmacologic Actions |
Docetaxel Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |