5-Fluorouracil Combined With CoFactor (5-10 Methylenetetrahydrofolate) in Treating Advanced Breast Cancer Patients

Not Applicable

• Conditions: -C509 Breast, unspecified; Breast, unspecified; C509

• Registration Number: PER-118-06
• Lead Sponsor: ADVENTRIX PHARMACEUTICALS U.S.A,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-05-29
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Signed informed consent.
2. Women with a histologically / cytologically proven diagnosis of breast adenocarcinoma.
3. Measurable disease. At least one non-bone lesion measurable in a one-dimensional form, with a diameter> 10 mm using computed helical computed tomography or magnetic resonance imaging according to the RECIST criteria.
4. Patients who have failed with both previous chemotherapy regimens with anthracycline and taxane derivatives.

Exclusion Criteria

1. Positive tumor Her2 / neu 2+ or 3+.
2. Pregnancy or lactation.
3. Systemic cytotoxic anticancer therapy, within ≤ 4 weeks of enrollment or 6 weeks if systemic therapy contains a nitrosourea or mitomycin.
4. Previous chemotherapy with 5-FU- and / or palliative chemotherapy based on capecitabine.
5. Extensive prior radiation therapy that affects more than 30% of the bone marrow reserves, or bone marrow / stem cell transplant.
6. Participation in clinical studies of non-approved experimental substances or procedures within ≤ 4 weeks of study enrollment.
7. History of another malignancy, unless the patient is cured and has been free of disease for ≥ 2 years.
8. Previous unforeseen reaction to fluoropyrimidines with or without documented deficiency of dihydropyrimidine dehydrogenase, or a history of hypersensitivity to 5-FU.
9. Psychological, family, sociological or geographical states that do not allow compliance with the protocol of the study and / or the study.
10. Significant heart disease, including symptomatic ventricular arrhythmia, congestive heart failure, myocardial infarction within 12 months prior to enrollment.
11. Concomitant treatment with any experimental drug or anticancer drug.

Study & Design

• Study Type: Interventional
• Study Design: Not specified