Clinical trial · Interventional
Docetaxel and Carboplatin in Treating Women With Metastatic Breast Cancer
Phase II Trial of Docetaxel and Carboplatin as First-Line Therapy for Metastatic Breast Cancer
NCT00005963CI-TRIAL-00025041completedPhase 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 chemotherapy drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and carboplatin in treating women who have metastatic 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- docetaxel + carboplatin
- description
- This is a multicenter study. Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease (SD), partial response (PR), or complete response (CR) may receive 4 additional courses past SD, PR, or CR. Patients are followed every 6 months for 2 years and then annually for 3 years.
- interventionNames
- Drug: carboplatin
- Drug: docetaxel
Primary outcomes (1)
- measure
- objective response rate
- timeFrame
- Up to 5 years
Secondary outcomes (2)
- measure
- time to progression
- timeFrame
- Up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically proven metastatic adenocarcinoma of the breast Measurable disease At least 20 mm in at least 1 dimension Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT/SGPT no greater than 2.5 times ULN Alkaline phosphatase no greater than ULN OR SGOT/SGPT no greater than ULN Alkaline phosphatase no greater than 4 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No myocardial infarction within the past 6 months No congestive heart failure No 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 unresolved infection No prior hypersensitivity reaction to docetaxel No grade 2 or greater sensory or motor neuropathy Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent prophylactic filgrastim (G-CSF) during the first course of study therapy Chemotherapy: No prior chemotherapy for metastatic disease Prior adjuvant chemotherapy allowed More than 1 year since prior paclitaxel, docetaxel, cisplatin, or carboplatin No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy to breast, chest wall, or axilla No prior radiotherapy to greater than 30% of bone marrow No concurrent radiotherapy Surgery: At least 4 weeks since prior major surgery and recovered Other: More than 7 days since prior IV antibiotics No concurrent experimental drugs
References
Publications (1)
- RESULTPerez EA, Suman VJ, Fitch TR, Mailliard JA, Ingle JN, Cole JT, Veeder MH, Flynn PJ, Walsh DJ, Addo FK. A phase II trial of docetaxel and carboplatin as first-line chemotherapy for metastatic breast cancer: NCCTG study N9932. Oncology. 2005;69(2):117-21. doi: 10.1159/000087813. Epub 2005 Aug 23. PMID 16118507