Status:
COMPLETED
Eribulin Plus Gemcitabine (EG) vs Paclitaxel Plus Gemcitabine (PG) in HER2-Negative Metastatic Breast Cancer
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Eisai Inc.
Dong-A ST Co., Ltd.
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
Metastatic breast cancer (MBC) is an incurable disease and is needed to improve effective chemotherapy. Paclitaxel plus Gemcitabine (PG) combination chemotherapy is one of the preferred chemotherapeut...
Detailed Description
A total of enrolled 118 patients in EG and PG groups, will be provided chemotherapy regimen: Paclitaxel/Gemcitabine (PG) : every 3 weeks D1 Paclitaxel 175mg/m2 + D5W 500mL MIV over 3hrs before gemcit...
Eligibility Criteria
Inclusion
- Histologically confirmed metastatic, or recurrent breast cancer
- HER2-negative breast cancer
- age \> 18 years
- ECOG performance status 0 - 2
- Pre- or postmenopausal breast cancer patients with measurable or non-measurable lesions, who are candidates for chemotherapy
- Life expectancy ≥ 3 months
- No prior history of chemotherapy for metastatic, recurrent breast cancer
- Patients may have received prior neoadjuvant or adjuvant taxane regimen as long as it has been 12 months since completion of regimen.
- Patients either may or may not have a prior anthracycline containing regimen.
- Prior hormonal therapy as a treatment of metastatic disease is allowed. But antitumoral hormonal therapy must be terminated prior to enrollment(up to the date of randomization)
- Prior radiation therapy allowed as long as \< 25% of the bone marrow has been treated, and the patients must have recovered from the acute toxic effects of the treatment prior to study enrollment. Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed 2 weeks before study entry.
- Bisphosphonates for the treatment of bone metastases should not be initiated following the first dose of randomized therapy. It must be initiated prior to day of treatment (cycle 1, day 1). Patients may continue on bisphosphonates who already established on bisphosphonate therapy for bone metastases
- Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
- Adequate renal function (≤ serum creatinine 1.5 mg/dl or CCr ≥ 50 ml/min)
- Adequate liver function (≤ serum bilirubin 1.5 mg/dl, ≤ AST \& ALTX3 upper normal limit or AST and ALT ≤ 5.0XULN if judged by the investigator to be related to liver metastases)
- Written informed consent
Exclusion
- Serious uncontrolled intercurrent infections
- Serious intercurrent medical or psychiatric illness, including active cardiac disease
- Pregnancy or breast feeding
- Second primary malignancy(except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence)
- Documented parenchymal or leptomeningeal brain metastasis
- Peripheral neuropathy ≥ grade 2
- Prior treatment with gemcitabine will not be allowed.
- HER-2 overexpressing breast cancer and concomitant trastuzumab treatment is not allowed
- Women of childbearing potential, unwilling to use a medically acceptable method of contraception during the trial
Key Trial Info
Start Date :
December 19 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2019
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT02263495
Start Date
December 19 2014
End Date
June 17 2019
Last Update
July 14 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Samsung Medical Center
Seoul, South Korea, 135-710
2
Asan Medical Center
Seoul, South Korea, 138-736