None listed
Conditions
Brief summary
Phase 3 This is a trial of the drug E7389 (eribulin) versus oral capecitabine in advanced breast cancer which has been treated with an anthracycline drug and a taxane drug. Who is it for? You can join this study if you are a woman with breast cancer which is locally advanced or has spread to secondary distant sites (metastases), and this has been treated previously with an anthracycline drug and a taxane drug. Trial details Capecitabine given orally twice daily for 14 days followed by a week's rest is widely-used treatment for people with breast cancer with progressive disease after anthracycline and taxane treatments. E7389 (eribulin) is a new drug derived from a marine sponge which stops cancer cells growing in the laboratory and has slowed cancer growth in some cancer people. Participants will be randomly divided into two groups. One group receives oral capecitabine (standard treatment). The other receives E7389 (eribulin) given intravenously on Days 1 and 8 every 21 days. The study aims to look at the effectiveness of the new treatment compared with capecitabine, and measures patient survival, whether the tumour responds and for how long.
Interventions
E7389 versus Capecitabine in Patients with Locally Advanced or Metastatic
Breast Cancer Previously Treated with Anthracyclines and Taxanes and
Refractory to the Most Recent Chemotherapy. The intervention group E7389. E7389 will be administered 1.4mg/m2 as an infusion or as an injection into the vein on days 1 and 8 of a 21 day cycle.
Patients will continue on the study until they meet one of the following:
- progressive disease
- loss of benefit due to side effects of treatment
- patient withd
E7389 versus Capecitabine in Patients with Locally Advanced or Metastatic Breast Cancer Previously Treated with Anthracyclines and Taxanes and Refractory to the Most Recent Chemotherapy. The intervention group E7389. E7389 will be administered 1.4mg/m2 as an infusion or as an injection into the vein on days 1 and 8 of a 21 day cycle. Patients will continue on the study until they meet one of the following: - progressive disease - loss of benefit due to side effects of treatment - patient withdraws consent -investigator decision in the best interests of the patient
Sponsors
Eisai
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with histologically or cytologically confirmed carcinoma of the breast. Patients with locally advanced or metastatic disease who have received either one anthracycline-taxane combination chemotherapy, or two prior therapies, including an anthracycline-based regimen without a taxane, and a taxane-based regimen. The order in which the regimens were received is unimportant. The treatments may have been administered as adjuvant or neoadjuvant chemotherapy and/or for the treatment of advanced or metastatic disease.If the treatment has been administered as adjuvant or neoadjuvant disease (no both), the patient must have progressed during the treatment or within one year of the last dose of the most recent chemotherapy treatment If the treatment has been administered for advanced or metastatic disease, the patient must have progressed during the last treatment or within six months of the last dose of the most recent chemotherapy treatment.
Exclusion criteria
Patients who have received more than two prior chemotherapy regimens for their disease, including adjuvant therapies (other therapies are allowed eg anti-estrogens, trastuzumab and radiotherapy).Patients who have received capecitabine as prior therapy for their disease.Patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment with E7389. Any signs (eg radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks.
Outcome results
None listed