Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer
Tracking Information | |||||
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First Received Date ICMJE | April 7, 2004 | ||||
Last Updated Date | January 18, 2012 | ||||
Start Date ICMJE | July 2003 | ||||
Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Correlation between change in apoptosis and proliferation with response after definitive surgery [ Time Frame: Definitive surgery ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
Correlation between change in apoptosis and proliferation with response after definitive surgery | ||||
Change History | Complete list of historical versions of study NCT00080626 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Correlation between change in fludeoxyglucose F 18 positron emission tomography uptake with response after definitive surgery [ Time Frame: Definitive surgery ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures ICMJE |
Correlation between change in fludeoxyglucose F 18 positron emission tomagraphy uptake with response after definitive surgery | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer | ||||
Official Title ICMJE | A Pilot Study Assessing Patterns of Response or Resistance to Preoperative Dose Dense Docetaxel in Women With Newly Diagnosed Breast Cancer | ||||
Brief Summary | RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed. PURPOSE: This phase II trial is studying how well neoadjuvant docetaxel works in treating women who are undergoing surgery for breast cancer. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a pilot study.
Patients are followed every 6 months. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | ||||
Intervention ICMJE |
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Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Enrollment ICMJE | 19 | ||||
Completion Date | |||||
Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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Gender | Female | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00080626 | ||||
Other Study ID Numbers ICMJE | J0266 CDR0000346460, P50CA088843, P30CA006973, JHOC-J0266, JHOC-03012301 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Sidney Kimmel Comprehensive Cancer Center | ||||
Study Sponsor ICMJE | Sidney Kimmel Comprehensive Cancer Center | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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Information Provided By | Sidney Kimmel Comprehensive Cancer Center | ||||
Verification Date | January 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |