Status:
COMPLETED
Epirubicin and Paclitaxel, Alone or Together With Capecitabine as First Line Treatment in Metastatic Breast Cancer
Lead Sponsor:
Thomas Hatschek
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Anthracycline-taxane regimens are effective means of postponing progression in metastatic breast cancer. It is yet unclear whether addition of capecitabine to this combination improves the treatment o...
Eligibility Criteria
Inclusion
- Morphologically proven breast carcinoma
- Written patient consent must be obtained
- Measurable disease (i.e. at least one lesion that can be accurately measured in at least one dimension as ≥20 mm by conventional techniques, or as ≥10 mm by spiral CT scan) as defined in section 8.
- Lytic and blastic bone metastases as only site of recurrence are allowed
- Age 18 years or older
- ECOG performance status 0-2
- Life expectancy of at least three months
- Adequate cardiac functions
- Adequate hematological, renal and hepatic functions
- Patient must be accessible for treatment and follow-up.
Exclusion
- Treatment-free interval less than one year, if previous adjuvant, neoadjuvant or after radically treated locoregional recurrence given regimen contained anthracycline, taxane or capecitabine. This limitation does not apply for regimens containing other than the drugs mentioned
- During adjuvant treatment obtained cumulative doses exceeding 375 mg/m2 for doxorubicin, or 550 mg/m2 for epirubicin, abnormal ECG or reduced cardiac function measured by left ventricular ejection fraction (LVEF).
- Indication for the use of trastuzumab (Herceptin) as first-line treatment in patients with tumor overexpressing c-erbB2.
- Any previous chemotherapy for metastatic disease, except for radically treated locoregional relapse
- Neoplasm other than breast carcinoma, except for non-melanoma skin cancer or curatively treated carcinoma in situ of the cervix, diagnosed during the past five years
- Pregnancy or lactation
- Known brain metastases
- History of atrial or ventricular arrhythmias and/or congestive heart failure, even if medically controlled. History of clinical and electrocardiographically documented myocardial infarction
- Preexisting motor or sensory neuropathy ≥ grade 2 according to NCI CTC 2.0 criteria (severe paresthesia and/or mild weakness, or worse)
- Severe hepatic or renal impairment (for capecitabine: calculated creatinine clearance below 30 ml/min; for calculation, see p. 5.1.4) not allowing for adequate use of the proposed regimens
- History of known dihydropyrimidine dehydrogenase (DPD) deficiency (severe reaction on previous treatment with fluorouracil, e.g experience of mucositis, hand-foot syndrome, or diarrhea)
- Active infection or other serious underlying medical condition which would impair the ability of the patient to receive protocol treatment, including prior allergic reactions to drugs containing cremophor, such as teniposide, cyclosporin or vitamin K
- Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent.
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT01433614
Start Date
December 1 2002
End Date
December 1 2013
Last Update
September 17 2015
Active Locations (9)
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1
Sahlgrenska University Hospital
Gothenburg, Sweden
2
Helsingborg Gen. Hospital
Helsingborg, Sweden
3
Kalmar Central Hospital
Kalmar, Sweden
4
Karlstad Gen. Hospital
Karlstad, Sweden