Clinical trial · Interventional
Combination Chemotherapy and Trastuzumab in Treating Women With Metastatic Breast Cancer
Randomized Phase II Trial of Paclitaxel, Carboplatin and rhuMAb Her-2 (Herceptin) as First-Line Chemotherapy in Patients With Metastatic Breast Cancer Who Overexpress Her-2
NCT00003612CI-TRIAL-00041041completedPhase 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 use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, carboplatin, and trastuzumab in treating women who have metastatic breast cancer that overexpresses HER2.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| trastuzumab | Biological | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Schedule A: paclitaxel + carboplatin + trastuzumab
- description
- Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes and then trastuzumab (Herceptin) IV over 90 minutes on day 1 of week 1. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30 minutes every 3 weeks until disease progression. Patients are followed every 3 months for 2 years and then every 6 months thereafter.
- interventionNames
- Biological: trastuzumab
- Drug: carboplatin
- Drug: paclitaxel
- type
- EXPERIMENTAL
- label
- Schedule B: paclitaxel + carboplatin + trastuzumab
- description
- Patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 15 minutes on day 1 of weeks 1-3 and trastuzumab IV over 90 minutes immediately after carboplatin on day 1. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30 minutes every 3 weeks until disease progression. Patients are followed every 3 months for 2 years and then every 6 months thereafter.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic adenocarcinoma of the breast * Strong overexpression of HER-2 by immunohistochemistry (3+) * 0-2+ tumors allowed if demonstrate amplification by FISH * Bidimensionally measurable disease * Brain metastasis must not represent sole site of disease * No untreated brain metastasis receiving radiotherapy * Previously treated brain metastases in continued response to radiotherapy and/or surgery for at least 2 months allowed * Hormone receptor status: * Positive or negative PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * No myocardial infarction within the past 6 months * No congestive heart failure or unstable angina * No clinically significant pericardial effusion or arrhythmia Other: * 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 * No active uncontrolled infection * No prior allergic reaction to Cremophor EL, anesthetics, or muscle relaxants * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent filgrastim (G-CSF) Chemotherapy: * Prior adjuvant chemotherapy allowed * Prior taxane therapy allowed * No prior cisplatin or carboplatin * No prior chemotherapy for metastatic disease Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * No prior radiotherapy to more than 25% of marrow * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * See Disease Characteristics * At least 4 weeks since prior surgery and recovered Other: * At least 7 days since prior parenteral antibiotics
References
Publications (4)
- RESULTPerez EA, Suman VJ, Rowland KM, Ingle JN, Salim M, Loprinzi CL, Flynn PJ, Mailliard JA, Kardinal CG, Krook JE, Thrower AR, Visscher DW, Jenkins RB. Two concurrent phase II trials of paclitaxel/carboplatin/trastuzumab (weekly or every-3-week schedule) as first-line therapy in women with HER2-overexpressing metastatic breast cancer: NCCTG study 983252. Clin Breast Cancer. 2005 Dec;6(5):425-32. doi: 10.3816/CBC.2005.n.047. PMID 16381626
- RESULTPerez EA, Rowland KM, Suman VJ, et al.: N98-32-52: efficacy and tolerability of two schedules of paclitaxel, carboplatin and trastuzumab in women with HER2 positive metastatic breast cancer: a North Central Cancer Treatment Group randomized phase II trial. [Abstract] Breast Cancer Res Treat 82 (Suppl 1): A-216, S47, 2003.
- RESULTRowland KM, Suman VJ, Ingle JN, et al.: NCCTG 98-32-52: randomized phase II trial of weekly versus every 3-week administration of paclitaxel, carboplatin and trastuzumab in women with HER2 positive metastatic breast cancer (MBC). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-31, 2003.
- DERIVEDChumsri S, Sperinde J, Liu H, Gligorov J, Spano JP, Antoine M, Moreno Aspitia A, Tan W, Winslow J, Petropoulos CJ, Chenna A, Bates M, Weidler JM, Huang W, Dueck A, Perez EA. High p95HER2/HER2 Ratio Associated With Poor Outcome in Trastuzumab-Treated HER2-Positive Metastatic Breast Cancer NCCTG N0337 and NCCTG 98-32-52 (Alliance). Clin Cancer Res. 2018 Jul 1;24(13):3053-3058. doi: 10.1158/1078-0432.CCR-17-1864. Epub 2018 Mar 12. PMID 29530935