Clinical Trials List
Protocol NumberL00070 IN 311 B0
2012-11-01 - 2014-12-31
Phase III
Terminated3
Study ended1
A multicentre, randomised, phase III study of vinflunine plus capecitabine versus capecitabine alone in patients with advanced breast cancer previously treated with an anthracycline and a taxane
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Trial Applicant
Orient EuroPharma Co., Ltd.
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Sponsor
Orient EuroPharma
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/19
Investigators and Locations
Co-Principal Investigator
- 曾信順 Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 甘蓉瑜 Division of Gastroenterological Surgery
- Chieh-Han Chuang Division of Gastroenterological Surgery
- Fu Ouyang Division of Gastroenterological Surgery
- Fang-Ming Chen Division of Gastroenterological Surgery
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 蘇智銘 Division of General Surgery
- CHIH-MING SU 未分科
- Tsu-Yi Chao Division of Hematology & Oncology
- Yao-Yu Hsieh Division of Hematology & Oncology
- 蘇勇誠 Division of Hematology & Oncology
- 吳志雄 Division of General Surgery
- 林漢斌 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 葉名焮 Division of General Surgery
- 林柏翰 Division of Hematology & Oncology
- Liang-Chih Liu Division of General Surgery
- Chih-Jung Chen Division of General Surgery
Condition/Disease
advanced breast cancer
Objectives
Objectives
- Primary objective:
• to compare in patients with advanced breast cancer pretreated with anthracycline and taxane the efficacy of the
combination of vinflunine and capecitabine with capecitabine alone, in terms of progression-free survival.
- Secondary objectives:
• to evaluate the response rate, the time to response and the duration of response in both arms
• to compare the disease control rate between arms
• to evaluate the duration of disease control in both arms
• to evaluate the overall survival in both arms
• to evaluate safety
Test Drug
JAVLOR
Active Ingredient
VINFLUNINE
Dosage Form
IV injection
Dosage
50mg/ 2ml; 250mg/ 10ml
Endpoints
The main endpoint of this study is to compare the progression-free survival in both treatment arms
on a superiority basis.
Secondary objectives are to determine the response rate, the time to response, the duration of
response, the disease control rate, the duration of disease control, and the overall survival in the 2
treatment arms.
on a superiority basis.
Secondary objectives are to determine the response rate, the time to response, the duration of
response, the disease control rate, the duration of disease control, and the overall survival in the 2
treatment arms.
Inclution Criteria
1. Patients must give written informed consent
2. Women with histologically or cytologically confirmed Her-2 negative carcinoma of the breast.
3. Documented locally recurrent or metastatic disease not amenable to curative surgery or radiotherapy.
4. Patients must have received either one, two or three prior chemotherapy regimens including those administered in
the neoadjuvant or adjuvant setting (neoadjuvant chemotherapy followed by adjuvant chemotherapy will count for
one line). At least one of the regimens must have been given for the treatment of advanced breast cancer.
5. Prior treatment must have included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e.,
paclitaxel or docetaxel) in any combination or order whatever the setting.
Note that the patients must have received a minimum cumulative dose of 240 mg/m² of doxorubicin or 300 mg/m²
of epirubicin.
6. Documented progression on or within 12 months of the most recent chemotherapy.
7. Prior hormone therapy is allowed either in the neoadjuvant and/or adjuvant setting and in the advanced setting
provided that the treatment is terminated 2 weeks prior to randomisation.
8. Prior radiation therapy is allowed to < 30% of the bone marrow and must be completed at least 3 weeks before
randomisation.
9. Must have measurable or non measurable disease according to RECIST (version 1.1). In patients who present with
a single lesion, a biopsy is required.
10. Adequate recovery from recent surgery. At least one week must have elapsed from the time of minor surgery, at
least 3 weeks for major surgery.
11. Estimated life expectancy ≥ 12 weeks.
12. Karnofsky performance score ≥ 70%.
13. Age ≥ 21 years and < 80 years.
14. Adequate haematological function defined by absolute neutrophil count > 1.5 x 109
/L, platelet count > 100 x 109
/L
and haemoglobin > 10 g/dL.
15. Adequate hepatic function defined by total bilirubin < 1.5 x upper limit of normal (ULN) ; aspartate
aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN (or < 5 x ULN in case of liver
metastases) ; alkaline phosphatase < 5 x ULN
16. Adequate renal function defined as calculated creatinine clearance > 50 ml/min according to Cockroft-Gault
formula
17. ECG without clinically relevant abnormality
18. Patients on coumadin or warfarin must be on stable doses and have an International Normalized Ratio (INR) ≤ 3 at
the time of screening.
19. Women of childbearing potential must be using a medically accepted method of contraception (i.e. intrauterine
devices, condom) to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the
study period and for up to 3 months after the last dose of study treatment in such a manner that the risk of
pregnancy is minimised. Women of childbearing potential must have a negative serum or urine pregnancy test
within 72 hours prior to first treatment administration.
20. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance
with the study protocol and follow-up schedule; those conditions should be assessed with the patient before
registration in the trial.
2. Women with histologically or cytologically confirmed Her-2 negative carcinoma of the breast.
3. Documented locally recurrent or metastatic disease not amenable to curative surgery or radiotherapy.
4. Patients must have received either one, two or three prior chemotherapy regimens including those administered in
the neoadjuvant or adjuvant setting (neoadjuvant chemotherapy followed by adjuvant chemotherapy will count for
one line). At least one of the regimens must have been given for the treatment of advanced breast cancer.
5. Prior treatment must have included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e.,
paclitaxel or docetaxel) in any combination or order whatever the setting.
Note that the patients must have received a minimum cumulative dose of 240 mg/m² of doxorubicin or 300 mg/m²
of epirubicin.
6. Documented progression on or within 12 months of the most recent chemotherapy.
7. Prior hormone therapy is allowed either in the neoadjuvant and/or adjuvant setting and in the advanced setting
provided that the treatment is terminated 2 weeks prior to randomisation.
8. Prior radiation therapy is allowed to < 30% of the bone marrow and must be completed at least 3 weeks before
randomisation.
9. Must have measurable or non measurable disease according to RECIST (version 1.1). In patients who present with
a single lesion, a biopsy is required.
10. Adequate recovery from recent surgery. At least one week must have elapsed from the time of minor surgery, at
least 3 weeks for major surgery.
11. Estimated life expectancy ≥ 12 weeks.
12. Karnofsky performance score ≥ 70%.
13. Age ≥ 21 years and < 80 years.
14. Adequate haematological function defined by absolute neutrophil count > 1.5 x 109
/L, platelet count > 100 x 109
/L
and haemoglobin > 10 g/dL.
15. Adequate hepatic function defined by total bilirubin < 1.5 x upper limit of normal (ULN) ; aspartate
aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN (or < 5 x ULN in case of liver
metastases) ; alkaline phosphatase < 5 x ULN
16. Adequate renal function defined as calculated creatinine clearance > 50 ml/min according to Cockroft-Gault
formula
17. ECG without clinically relevant abnormality
18. Patients on coumadin or warfarin must be on stable doses and have an International Normalized Ratio (INR) ≤ 3 at
the time of screening.
19. Women of childbearing potential must be using a medically accepted method of contraception (i.e. intrauterine
devices, condom) to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the
study period and for up to 3 months after the last dose of study treatment in such a manner that the risk of
pregnancy is minimised. Women of childbearing potential must have a negative serum or urine pregnancy test
within 72 hours prior to first treatment administration.
20. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance
with the study protocol and follow-up schedule; those conditions should be assessed with the patient before
registration in the trial.
Exclusion Criteria
1. Patients with known or with clinical evidence of brain metastasis or leptomeningeal involvement
2. Patients with pulmonary lymphangitis or symptomatic pleural effusion (grade > 2) that results in pulmonary
dysfunction requiring active treatment.
3. Patients having received any other experimental drug or chemotherapy within 30 days before randomisation.
4. History of second primary malignancy, except: bilateral breast carcinoma, in situ carcinoma of the cervix,
adequately treated non melanomatous carcinoma of the skin, and other malignancy treated at least 5 years
previously with no evidence of recurrence.
5. Patients with pre-existing motor/sensory peripheral neuropathy of NCI CTCAE version 3.0 grade > 1.
6. Patients having received > 3 regimens of chemotherapy
7. Prior therapy with capecitabine and/or vinca alkaloids (including vinflunine)
8. History of severe hypersensitivity to vinca alkaloids and/or to fluoropyrimidine or any contra indication to any of
the study drugs.
9. Known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency.
10. A female is not eligible to enter the study if: pregnant or lactating or with positive pregnancy test at inclusion.
11. Female of childbearing potential who is unwilling or unable to use a medically accepted method to avoid pregnancy
during the 2 months preceding the start of study treatment, throughout the study period and at least 3 months
following the last dose of study treatment.
12. Known history of HIV infection.
13. Inability to take and/or absorb oral medication including previous gastric surgery or any evidence of partial
oesophageal, gastric, small or large bowel obstruction; gastrointestinal disorder that affect the absorption of
capecitabine (malabsorption syndrome, 2/3 gastric resection and bowel resection).
14. Patients who have any serious, concurrent uncontrolled medical disorder especially uncontrolled hypercalcaemia,
congestive heart failure, uncontrolled high-risk hypertension, arrhythmia, angina pectoris or previous history of
myocardial infarction within 6 months prior to randomisation
15. Prior bone marrow transplantation or autologous stem cell infusion following high-dose chemotherapy.
2. Patients with pulmonary lymphangitis or symptomatic pleural effusion (grade > 2) that results in pulmonary
dysfunction requiring active treatment.
3. Patients having received any other experimental drug or chemotherapy within 30 days before randomisation.
4. History of second primary malignancy, except: bilateral breast carcinoma, in situ carcinoma of the cervix,
adequately treated non melanomatous carcinoma of the skin, and other malignancy treated at least 5 years
previously with no evidence of recurrence.
5. Patients with pre-existing motor/sensory peripheral neuropathy of NCI CTCAE version 3.0 grade > 1.
6. Patients having received > 3 regimens of chemotherapy
7. Prior therapy with capecitabine and/or vinca alkaloids (including vinflunine)
8. History of severe hypersensitivity to vinca alkaloids and/or to fluoropyrimidine or any contra indication to any of
the study drugs.
9. Known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency.
10. A female is not eligible to enter the study if: pregnant or lactating or with positive pregnancy test at inclusion.
11. Female of childbearing potential who is unwilling or unable to use a medically accepted method to avoid pregnancy
during the 2 months preceding the start of study treatment, throughout the study period and at least 3 months
following the last dose of study treatment.
12. Known history of HIV infection.
13. Inability to take and/or absorb oral medication including previous gastric surgery or any evidence of partial
oesophageal, gastric, small or large bowel obstruction; gastrointestinal disorder that affect the absorption of
capecitabine (malabsorption syndrome, 2/3 gastric resection and bowel resection).
14. Patients who have any serious, concurrent uncontrolled medical disorder especially uncontrolled hypercalcaemia,
congestive heart failure, uncontrolled high-risk hypertension, arrhythmia, angina pectoris or previous history of
myocardial infarction within 6 months prior to randomisation
15. Prior bone marrow transplantation or autologous stem cell infusion following high-dose chemotherapy.
The Estimated Number of Participants
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Taiwan
30 participants
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Global
334 participants
