Tablets of Mifepristone 200 mg p.o. once a day during 14 days between biopsy and surgery after confirming inclusion criteria

Breast Cancer

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.

Mifepristone

HospitalPMVM

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

Mifepristone Treatment for Breast Cancer Patients Expressing Levels of Progesterone Receptor Isoform A (PRA) Higher Than Those of Isoform B (PRB): Neoadjuvant Therapy.

Treatment efficacy will be assessed by comparing tissue samples from the baseline biopsy and tissue samples collected from the day of surgery, evaluating if there is a decrease in the proliferating index (Ki-67 expression by immunohistochemistry). Positive response: differences higher than 30%.

Treatment efficacy will be assessed by comparing tissue samples from the baseline biopsy and tissue samples collected from the day of surgery, evaluating if there is an increase in apoptotic cells measuring TUNNEL and caspase 3 expression. Positive response: difference higher than 30%.

MFP action will be measured evaluating the expression of downstream markers related to PR activation such as CCND1, MYC, pSTAT5 and other proteins by immunohistochemistry. Positive response: differences higher than 30%

Measured by ecographic imaging. Twenty per cent of decrease in overall tumor size will be considered as a significant change.

Differences in gene expression between biopsy core and surgery sample higher than 20 % will be considered as an effective drug response.

Levels of Mifepristone will be measured by HPLC in the blood sample after treatment and correlate these levels with response to treatment (outcome 1).

Hospital Provincial Magdalena V. de Martínez

National Agency for Scientific and Technological Promotion, Argentina

Instituto de Biología y Medicina Experimental (IBYME-CONICET)

Clinical follow-up, no active intervention.

Lipotransplantation in general anaesthesia to the mastectomy site.

Chronic Pain

Lipotransplantation in general anaesthesia to the mastectomy site

Lipotransplantation

The Danish Cancer Society: Incidence of breast cancer in Denmark

The Danish Breast Cancer Group: Responsible for developing national guidelines for the treatment of breast cancer in Denmark

Aarhus University Hospital

Investigation of the Pain Relieving Properties of Lipotransplantation After Treatment for Breast Cancer

A Prospective, Randomized Study of the Possible Pain Relieving and Scar Tissue Modifying Properties of Lipotransplantation in a "Post Breast Therapy Pain Syndrome" Setting

The pain in the area around the mastectomy will be measured using visual analog scales (DoloTest), at inclusion of the patient, and at three follow-up visits 3, 6 and 12 months after inclusion.

Changes in the proportions of collagen type I and III in the mastectomy scar.

Changes in the elastin content of the mastectomy scar.

Changes in the number of free nerve endings crossing the border between the dermis and the epidermis per millimeter in the skin of the pain afflicted area around the mastectomy scar.

Changes in the mastectomy scar quality, measured using the Patient and Observer Scar Assessment Scale.

Changes in the analgesic consumption of the patients included in the study.

Alexander Juhl Andersen

M.D.

University of Aarhus

Breast Neoplasms

Lung Neoplasms

Ovarian Neoplasms

Sarcoma, Soft Tissue

Laboratory Assay

Chemotherapy doctor determined from results

formaldehyde/breast neoplasms

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

Investigation of the Pain Relieving Properties of Lipotransplantation After Treatment for Breast Cancer

Chemotherapy Drug Sensitivity Microculture (MiCK) Assay for Apoptosis

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