MedTrace Logo

Mifepristone for Breast Cancer Patients With Higher Levels of Progesterone Receptor Isoform A Than Isoform B.

NCT02651844 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-05-06

No results posted yet for this study

Summary

* Seventy per cent of breast cancers express estrogen (ER) and progesterone receptors (PR) and respond to endocrine treatment.
* Actual therapy targets ER.
* There is enough evidence that progestins participate regulating breast cancer growth.
* Antiprogestins block cell proliferation and increase apoptosis in breast cancer models which express high levels of PRA.
* Antiprogestins have been used to treat breast cancer patients that failed to other treatments; benefits were seen in selected patients.
* Mifepristone (MFP) is currently used for medical abortion and for the treatment of Cushing disease.
* MFP might exert agonistic effects when PRB isoform is activated by cAMP. This makes mandatory the evaluation of the PR isoform ratio in breast cancer patients in which MFP is a therapeutic possibility.

Main Goal To evaluate if therapeutic doses of MFP exert beneficial effects on breast cancers expressing levels of PRA higher than those of PRB, evaluated as an inhibition in proliferation markers and/or an increase in apoptotic markers.

* Eligibility

* Postmenopausal women (one year after menses stop).
* Women with tumors showing ratios of PRA/PRB higher than 1.5 and PR higher than 50%.
* Women without previous treatment.
* All clinical stages with tumors larger than 1.5 cm.
* Patients without autoimmune diseases and/or asthma.
* Study design

* Open Interventional.
* Twenty women will take MFP (200 mg) p.o. once /day during 14 days. As for preliminary studies, to reach this number the investigators will have to evaluate 80-100 patients.
* Surgery is performed 14 days after treatment initiation, 24 hs after last dose.
* PR isoform ratio will be evaluated by western blots (WB) in one core biopsy. Additional cores will be used for diagnosis, immunohistochemistry (IHC) of PR, Ki-67 and other markers.
* At surgery samples will be frozen for molecular studies and fixed and processed for pathological evaluation.
* Wilcoxon signed rank test will be used to evaluate differences in biomarker expression between core biopsy and surgical samples of each patient.
* Blood will be collected before treatment initiation and prior to final surgery.
* Mammographic and echographic studies will be carried out before and after treatment.

Conditions

Interventions

DRUG

Mifepristone

At the time a patient enters the protocol, 14 pills will be given to the personnel responsible of giving the patient the medicine at her home (This was a special requirement from the Argentine Authorities). Patients and personnel will sign the form each then she gets the medication and after that the signed form will be kept at the CRF file.

Sponsors & Collaborators

  • National Agency for Scientific and Technological Promotion, Argentina

    collaborator OTHER

  • Instituto de Biología y Medicina Experimental (IBYME-CONICET)

    collaborator UNKNOWN

  • Hospital Provincial Magdalena V. de Martínez

    lead OTHER

Principal Investigators

  • Claudia Lanari, PhD · IBYME-CONICET

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2019-10-31
Completion
2019-10-31

Countries

  • Argentina

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02651844 on ClinicalTrials.gov