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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 7, 2004 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | July 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Correlation between change in apoptosis and proliferation with response after 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 tomagraphy uptake with response after 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 | ||||
| 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 Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Breast Cancer | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| 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 ID ICMJE | NCT00080626 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000346460, JHOC-J0266, JHOC-03012301 | ||||
| Study Sponsor ICMJE | Sidney Kimmel Comprehensive Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | May 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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