Phase 2
Completed N=27
A Study to Determine the Activity of Caelyx With Trastuzumab and Docetaxel in the Treatment of Metastatic Breast Cancer (Study P03679)
Breast Neoplasm
Source: ClinicalTrials.gov NCT00687440 ↗
Enrolled (actual)
27
Serious AEs
22.2%
Results posted
Feb 2010
Primary outcomePrimary: Number of Participants Who Had a Tumor Response, According to Standard RECIST (Response Evaluation Criteria in Solid Tumors) Criteria — 2; 13; 11 Participants
Summary
The purpose of this study is to evaluate, in a first stage, the safety (incidence of cardiac toxicity) of Caelyx in combination with Trastuzumab and Docetaxel; and in a second stage, the tumor response rate of this regimen. This study will be conducted in approximately 30 centers. A total of approximately 70 to 95 subjects will be enrolled.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Had a Tumor Response, According to Standard RECIST (Response Evaluation Criteria in Solid Tumors) Criteria |
2; 13; 11 | — |
Eligibility Criteria
Inclusion Criteria
Patients must fulfill all the following criteria:
- Females aged 18 to 70 years-old.
- Willingness to participate in the study and comply with its procedures.
- Documented diagnosis of metastatic breast carcinoma (stage IV) Human Epidermal Growth Factor Receptor 2 (HER2) overexpressing (Immunohistochemistry (IHC) 3+ or Fluorescence In Situ Hybridization(FISH) +).
- No prior chemotherapy for metastatic breast cancer.
- Adjuvant or neo-adjuvant chemotherapy is allowed according to the following rules:
- patients treated with anthracyclines if all the following conditions are met:
- Doxorubicin total dose 12 months
- no taxane-based adjuvant or neo-adjuvant chemotherapy is allowed;
- patients treated with non-anthracycline/taxane adjuvant or neo-adjuvant chemotherapy regimens are freely eligible (i.e. cyclophosphamide/methotrexate/fluorouracil (CMF) or similar regimens).
- At least one measurable lesion according to RECIST criteria.
- Complete hematologic and biologic baseline evaluation within 2 weeks prior to start of treatment.
- Complete Tumor baseline evaluation including a total body computed tomography (CT) scan within 4 weeks prior to start of treatment.
- Left ventricular ejection fraction (LVEF) >= 50% as determined by echocardiogram or Multi Gated Acquisition (MUGA) scan.
- World Health Organization (WHO) performance status 0,1.
- Life expectancy > 3 months.
- Laboratory requirements :
- Hematology :
- Neutrophils > 1.5 x 10^9/L
- Platelets > 100 x 10^9/L
- Hemoglobin > 10 g/dL
- Hepatic function:
- Total bilirubin grade 2 according to the National Cancer Institute (NCI) Common Toxicity Criteria.
- Other serious illness or medical condition.
- LVEF 6 months) at low dose (< 20 mg of methylprednisolone or equivalent dose of other corticosteroids) for whichever reason are eligible.
- Taxane-based adjuvant or neo-adjuvant chemotherapy < 12 months.
- Other concurrent chemotherapy, immunotherapy, radiotherapy or any other investigational medication, for the treatment of the tumor.
- Pregnant or breast-feeding women.
Data sourced from ClinicalTrials.gov (NCT00687440). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.