Status:
TERMINATED
Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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...
Detailed Description
OBJECTIVES: Primary * Correlate baseline and change in apoptosis and proliferation with clinical and pathological response to neoadjuvant docetaxel followed by surgery in women with newly diagnosed ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 11 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00080626
Start Date
August 11 2003
End Date
May 1 2006
Last Update
March 21 2019
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410