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| Tracking Information | |||||
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| First Received Date ICMJE | November 9, 2004 | ||||
| Last Updated Date | April 14, 2009 | ||||
| Start Date ICMJE | September 2004 | ||||
| Estimated Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00096109 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | 17-N-Allylamino-17-Demethoxygeldanamycin (17-AAG) in Treating Women With Refractory Locally Advanced or Metastatic Breast Cancer | ||||
| Official Title ICMJE | A Phase II Clinical Trial Of 17-Allylamino-17-Demethoxygeldanamycin (17-AAG) In Chemotherapy Refractory Metastatic Breast Cancer | ||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin (17-AAG), work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well 17-AAG works in treating women with refractory locally advanced or metastatic breast cancer. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study. Patients receive 17-N-allylamino-17-demethoxygeldanamycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed at day 30, every 10-12 weeks until disease progression, and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 14 months. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE | Breast Cancer | ||||
| Intervention ICMJE | Drug: tanespimycin | ||||
| 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 | 37 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Sex
Menopausal status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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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 | NCT00096109 | ||||
| Responsible Party | Patricia M. LoRusso, Barbara Ann Karmanos Cancer Institute | ||||
| Study ID Numbers ICMJE | CDR0000391198, WSU-C-2803, NCI-6552 | ||||
| Study Sponsor ICMJE | Barbara Ann Karmanos Cancer Institute | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | October 2008 | ||||
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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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