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This study investigated the effect of the drug Mifepristone in breast cancer patients whose tumors had higher levels of progesterone receptor isoform A than isoform B. It enrolled postmenopausal women with a confirmed diagnosis of breast cancer. It was conducted as a non-phase study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Inclusion criteria 1. Postmenopausal women (one year after menses stop) 2. Confirmed diagnosis of breast cancer 3. Tumors with higher expression PR \> 50 % measured by IHC and PRA/RPB ratio equal or higher than 1.5 measured by WB 4. All clinical stages with tumor size greater than 1.5 cm to allow obtaining material from biopsy cores 5. OMS condition: 1 Adequate function of organs and systems Hematopoietic parameters: * Hemoglobin: 10 gr/mL * Neutrophil counting: 1.500/mm3 * CD4 counting: 400/mm3 * Platelets counting: 100.000/mm3 Liver parameters * Total albumin: 1.5 fold normal limit * AST/ALT: 1.5 fold normal limit Renal * Creatinine: 1.5 fold normal limit 6. Absence of other controlled disease 7. Patients willing to sign consent Exclusion Criteria: * Exclusion criteria 1. Patients with no recommended surgery 2. Patients which have received any other treatment for this cancer 3. Patients expressing ER but expressing PRA/PRB levels lower than 1.5 4. Hepatitis infection (HBV o HCV) 5. HIV infection. 6. Cognitive alterations which limit the understanding of the protocol or compliance to the protocol 7. Prolonged QT/QTc basal interval