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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 March 2013 |
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Main ID: |
NCT00080626 |
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Date of registration:
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07/04/2004 |
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Primary sponsor: |
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Public title:
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Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer
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Scientific title:
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A Pilot Study Assessing Patterns of Response or Resistance to Preoperative Dose Dense Docetaxel in Women With Newly Diagnosed Breast Cancer |
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Date of first enrolment:
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July 2003 |
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Target sample size:
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19 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00080626 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Vered Stearns, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sidney Kimmel Comprehensive Cancer Center |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Histologically confirmed infiltrating carcinoma of the breast
- Unresected clinical stage T1c, T2, T3, or T4 lesion, any N
- Newly diagnosed disease
- Diagnostic mammogram and an ultrasound of the affected breast within 3 months
before study entry
- Mammogram of the contralateral breast within 6 months before study entry
- Clinically measurable disease
- Hormone receptor status:
- Immunohistochemical staining for estrogen and progesterone and HER2/neu
receptors must be obtained on initial diagnostic material
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Female
Menopausal status
- Not specified
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 8 g/dL
Hepatic
- Bilirubin no greater than 1.5 times normal
Renal
- Creatinine no greater than 1.5 times normal
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No medical condition that would put the patient at unnecessary risk of potentially
serious complications during study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for current breast cancer
Endocrine therapy
- At least 1 month since prior tamoxifen or raloxifene for breast cancer prevention
- No prior endocrine therapy for current breast cancer
Radiotherapy
- No prior radiotherapy for current breast cancer
Surgery
- Not specified
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Biological: pegfilgrastim
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Drug: docetaxel
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Procedure: conventional surgery
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Procedure: neoadjuvant therapy
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Primary Outcome(s)
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Correlation between change in apoptosis and proliferation with response after definitive surgery
[Time Frame: Definitive surgery]
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Secondary Outcome(s)
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Correlation between change in fludeoxyglucose F 18 positron emission tomography uptake with response after definitive surgery
[Time Frame: Definitive surgery]
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Secondary ID(s)
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J0266 CDR0000346460
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JHOC-03012301
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JHOC-J0266
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P30CA006973
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P50CA088843
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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