A Study of Vinflunine Plus Gemcitabine Versus Paclitaxel Plus Gemcitabine in Patients With Advanced Breast Cancer (VICTORIA)
- Conditions
- -C50 Malignant neoplasm of breastMalignant neoplasm of breastC50
- Registration Number
- PER-057-07
- Lead Sponsor
- PIERRE FABRE MEDICAMENT,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 49
1. Patients must give written informed consent before performing any procedure related to the study.
2. Women suffering from carcinoma of the breast with histological or cytological confirmation.
3. Locally recurrent or documented metastatic disease not amenable to surgery or radiotherapy with curative intent.
4. Patients with: A) Negative HER-2 disease, assessed by IHC 0-1 + or FISH / CISH negative, in the primary tumor or in the metastatic location. B) Unknown status HER-2. as long as a tumor sample is available for retrospective evaluation.
5. Patients will have received prior adjuvant chemotherapy based on anthracycline with or without a taxane.
6. Previous hormonal treatment is allowed in neoadjuvant and / or adjuvant and in the metastatic setting.
7. Previous radiation therapy is allowed in <25% of the bone marrow and must have been completed at least 4 weeks before randomization.
8. Patients with measurable or non-measurable lesion according to the RECIST criteria.
9. Estimated life expectancy ≥ 12 weeks.
10. Kamofsky´s functional status score ≥ 70%.
11. Age ≥ 18 years and ≤ 75 years.
12. Adequate haematological function.
13. Adequate liver function.
14. Adequate renal function.
15. ECG without clinically important alterations.
16. Women of childbearing potential must use a medically accepted method of contraception during the two months prior to the start of study treatment, during the study period and for up to three months after the last dose of study treatment.
1. Patients who have received prior chemotherapy for metastatic disease or who have progressed while receiving chemotherapy.
2. Patients with cerebral metastases or leptomeningeal involvement.
3. Inflammatory breast cancer without evidence of metastatic disease.
4. Patients who have received any other experimental treatment or antineoplastic treatment in the 30 days prior to randomization.
5. Concomitant treatment with any other experimental treatment or antineoplastic treatment.
6. History of the second primary malignant tumor.
7. Patients presenting as only tumor lesions any of the following: malignant effusion, lymphangitis, cystic lesions, bone lesions.
8. Patients with a previous existence of peripheral motor or sensory neuropathy of grade> 1 according to the CTCAE criteria version 3.0.
9. Previous therapy with gemcitabine and / or vinca alkaloids.
10. History of serious hypersensitivity to vinca alkaloids and / or gemcitabine and / or taxanes or any contraindication to any of the drugs under study.
11. Pregnant women or breastfeeding women.
12. Patients who present a serious uncontrolled concurrent medical disorder.
13. Previous bone marrow transplant or autologous stem cell infusion after high-dose chemotherapy.
14. Patients in any psychological, family, sociological or geographical situation that may hinder compliance with the study protocol and the follow-up program.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Determination of the time from randomization to the progression of the disease, which is defined as: A) A 20% increase in the sum of the larger diameters of the target lesions or the appearance of one or more new target lesions. B) Appearance of one or more new lesions and / or the unequivocal progression of existing non-target lesions.<br>Measure:Progression Free Survival.<br>Timepoints:Every 6 weeks until the progression of the disease.<br>
- Secondary Outcome Measures
Name Time Method