Clinical trial · Interventional
Docetaxel, Carboplatin, and Pegfilgrastim in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer
Phase II Trial of Docetaxel and Carboplatin Administered Every Two Weeks as Induction Therapy for Stage II or III Breast Cancer
NCT00107510CI-TRIAL-00022883completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| docetaxel | Drug | Docetaxel | ALIAS |
| pegfilgrastim | Biological | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- docetaxel + carboplatin + pegfilgrastim + surgery
- description
- 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.
- interventionNames
- Biological: pegfilgrastim
- Drug: carboplatin
- Drug: docetaxel
- Procedure: conventional surgery
Primary outcomes (1)
- measure
- Pathological complete response rate by histologic evaluation at definitive surgery
- timeFrame
- Up to 5.5 years
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 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: Surgery * No prior surgical resection for invasive breast cancer Other * No other prior therapy for invasive breast cancer
References
Publications (4)
- BACKGROUNDReinholz MM, Kitzmann KK, Hillman D, et al.: Differential gene expression in circulating tumor cells between primary and metastatic breast cancer patients. [Abstract] Breast Cancer Res Treat 106 (1): A-5022, S213-4, 2007.
- RESULTRoy V, Pockaj BA, Allred JB, Apsey H, Northfelt DW, Nikcevich D, Mattar B, Perez EA. A Phase II trial of docetaxel and carboplatin administered every 2 weeks as preoperative therapy for stage II or III breast cancer: NCCTG study N0338. Am J Clin Oncol. 2013 Dec;36(6):540-4. doi: 10.1097/COC.0b013e318256f619. PMID 22868240
- RESULTApsey H, Roy V, Pockaj B, et al.: Surgical practice patterns following NCCTG N0338 "Phase II trial of docetaxel and darboplatin administered every two weeks as induction therapy for stage II and stage III breast cancer". [Abstract] J Clin Oncol 27 (Suppl 15): A-623, 2009.
- RESULTPockaj BA, Mukherjee P, Tinder TL, et al.: NCCTG N0338: effect of docetaxel and carboplatin on VEGF, PGE2, and immune cells in patients with stage II or III breast cancer. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-5110, 2008.