Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Sidney Kimmel Comprehensive Cancer Center
Collaborator:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00080626
First received: April 7, 2004
Last updated: March 18, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: pegfilgrastim Drug: docetaxel Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study Assessing Patterns of Response or Resistance to Preoperative Dose Dense Docetaxel in Women With Newly Diagnosed Breast Cancer |
Resource links provided by NLM:
Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:
Primary Outcome Measures:
- Correlation between change in apoptosis and proliferation with response after definitive surgery [ Time Frame: Definitive surgery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 19 |
| Study Start Date: | July 2003 |
| Estimated Study Completion Date: | December 2015 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Docetaxel
Neoadjuvant therapy with docetaxel (IV, 100 mg/m2, every 14 days with growth factor support with pegfilgrastim) for a total of 4 cycles prior to conventional surgery for breast cancer
|
Biological: pegfilgrastim
6 mg injection on day 1 of each cycle
Other Name: Neulasta
Drug: docetaxel
100 mg per meter-squared, every 14 days for 4 cycles
Other Name: Taxotere
Procedure: conventional surgery
lumpectomy or mastectomy at end of treatment
Other Name: definitive surgery
Procedure: neoadjuvant therapy
treatment prior to definitive breast surgery
|
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 breast cancer.
Secondary
- Correlate baseline and change in fludeoxyglucose F 18 positron emission tomography uptake with clinical and pathological response in patients treated with this regimen.
- Correlate baseline and change in gene expression profiles with clinical and pathological response in patients treated with this regimen.
- Correlate baseline and change in tumor and serum proteomic patterns with clinical and pathological response in patients treated with this regimen.
OUTLINE: This is a pilot study.
- Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour on day 1 and pegfilgrastim subcutaneously (SC) on day 2. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
- Surgery: Within 2-4 weeks after the completion of 4 courses of docetaxel, patients undergo breast-conserving surgery or a mastectomy at the discretion of the treating surgeon. Patients may receive additional chemotherapy prior to surgery at the discretion of the treating physician.
- Adjuvant chemotherapy: Patients receive adjuvant chemotherapy at the discretion of the treating physician.
- Radiotherapy: Patients undergo radiotherapy after the completion of all chemotherapy at the discretion of the treating physician.
- Hormonal therapy: Patients with estrogen- and/or progesterone-positive tumors receive hormonal therapy after the completion of chemotherapy and all local therapies at the discretion of the treating physician.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00080626
Locations
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
| Principal Investigator: | Vered Stearns, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00080626 History of Changes |
| Other Study ID Numbers: | J0266 CDR0000346460, P50CA088843, P30CA006973, JHOC-J0266, JHOC-03012301 |
| Study First Received: | April 7, 2004 |
| Last Updated: | March 18, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
|
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Docetaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013