Docetaxel, Carboplatin, and Pegfilgrastim in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer
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Purpose
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving docetaxel and carboplatin together with pegfilgrastim before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well giving docetaxel and carboplatin together with pegfilgrastim works in treating patients who are undergoing surgery for stage II or stage III breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: pegfilgrastim Drug: carboplatin Drug: docetaxel Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Docetaxel and Carboplatin Administered Every Two Weeks as Induction Therapy for Stage II or III Breast Cancer |
- Pathological complete response rate by histologic evaluation at definitive surgery [ Designated as safety issue: No ]
- Toxicity profile by CTCAE v3.0 at baseline and each subsequent evaluation [ Designated as safety issue: Yes ]
- Rate of breast conserving surgery at definitive surgery after neoadjuvant chemotherapy [ Designated as safety issue: No ]
- Clinical response rate by clinical examination prior to definitive surgery [ Designated as safety issue: No ]
| Estimated Enrollment: | 58 |
| Study Start Date: | August 2005 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Determine the pathological complete response rate in patients with stage II or III breast cancer treated with neoadjuvant docetaxel, carboplatin, and pegfilgrastim.
Secondary
- Determine the toxicity profile of this regimen in these patients.
- Determine the rate of breast-conserving surgery in patients treated with this regimen.
- Determine the clinical response rate in patients treated with this regimen.
- Determine the feasibility of drug administration, in terms of the percent of planned dose actually administered per course, in patients treated with this regimen.
- Determine the proportion of patients with negative pathologic lymph node status after treatment with this regimen.
- Determine the proportion of patients with residual ductal carcinoma in situ after treatment with this regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Patients also receive pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
No more than 6 weeks after completion of chemotherapy, patients undergo definitive surgery.
After completion of study therapy, patients are followed every 6 months until disease progression and then annually for up to 5 years. Patients who do not complete all 4 courses of chemotherapy or do not undergo surgery are followed every 6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 25-58 patients will be accrued for this study within 21-23 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of breast cancer
- Clinical stage II or III disease (including T2-4, N0-3)
No clinical or radiological evidence of distant metastases
- Isolated supraclavicular lymph node involvement allowed
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Male or female
Menopausal status
- Not specified
Performance status
- ECOG 0-1
Life expectancy
- At least 3 months
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10.0 g/dL
Hepatic
- Bilirubin normal
Meets 1 of the following criteria:
- AST or ALT ≤ 5 times upper limit of normal (ULN) AND alkaline phosphatase normal
- AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN
- AST or ALT normal AND alkaline phosphatase ≤ 5 times ULN
Renal
- Creatinine clearance ≥ 30 mL/min
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 30 days after study treatment
- No active unresolved infection
- No history of severe hypersensitivity reaction to docetaxel, carboplatin, or any other drug formulated with polysorbate 80
- No known hypersensitivity to E. coli-derived proteins, filgrastim (G-CSF), or pegfilgrastim
- No peripheral neuropathy ≥ grade 2
- No other invasive malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- No prior surgical resection for invasive breast cancer
Other
- No other prior therapy for invasive breast cancer
Contacts and Locations
Show 120 Study Locations| Study Chair: | Vivek Roy, MD, FACP | Mayo Clinic |
| Investigator: | Edith A. Perez, MD | Mayo Clinic |
| Investigator: | Robert T. Chambers, MD, FRCSC, FACS | MeritCare Wahpeton |
| Investigator: | Judith E. Hurley, MD | University of Miami Sylvester Comprehensive Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00107510 History of Changes |
| Other Study ID Numbers: | CDR0000420834, NCCTG-N0338 |
| Study First Received: | April 5, 2005 |
| Last Updated: | August 18, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer male breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Docetaxel Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013