Evaluation of ATRA Activity in Combination With Anastrozole in Pre-operative Phase of Operable Early Breast Cancer

Launched by MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH · Oct 1, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of a medication called all-trans retinoic acid (ATRA) when used alongside another drug, anastrozole, in women who have early-stage breast cancer that is hormone receptor-positive and HER2-negative. The goal is to see if this combination can help shrink tumors before surgery in postmenopausal women diagnosed with this specific type of breast cancer. This study is taking place in Italy and is currently recruiting participants.

To be eligible for this trial, women must be at least 18 years old, have a confirmed diagnosis of operable breast cancer, and be postmenopausal. They should not have any signs of cancer that has spread, and must meet certain health criteria to ensure they can safely participate. Participants will receive the study drugs before their scheduled surgery and will be closely monitored throughout the process. It's important for potential participants to understand that this study aims to explore new treatment options and may help improve future care for breast cancer patients.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed, informed consent
• • 2. Histologically confirmed non-metastatic operable primary invasive HR-positive breast cancer subjected to diagnostic core biopsy
• • 3. Menopausal status
• • 4. HR-positive/HER2-negative eBC defined as
• • ER\>1% on immunohistochemistry (IHC) staining
• • HER2 score equal to 0, 1+, 2+ (if FISH neg) on IHC staining
• • 5. Available paraffin-embedded tumor block (FFPE) taken at diagnostic biopsy for Ki67 determination (IHC)
• 6. Adequate bone marrow, hepatic and renal function including the following:
• • 1. Hb ≥ 9.0 g/dL, absolute neutrophil count ≥ 1.5 x 109/L, platelets ≥100 x 109/L
• • 2. Total bilirubin ≤ 1.5 x upper normal limit, excluding cases where elevated bilirubin can be attributed to Gilberts Syndrome
• • 3. AST (SGOT), ALT (SGPT) ≤ 2.5 x upper normal limit (or 5x UNL in the presence of liver metastases)
• • 4. Creatinine ≤ 1.5 x upper normal limit
• • 7. Age ≥ 18 years
• • 8. Performance status (PS) ≤ 1 (ECOG scale)
• Exclusion Criteria:
• • 1. Presence of metastatic disease
• • 2. Pre-menopausal status
• • 3. Previous investigational treatment for any condition within 4 weeks of randomization date
• • 4. Treatment including radiation therapy, chemotherapy, biotherapy and/or hormonal therapy for the currently diagnosed breast cancer prior to study entry
• • 5. Co-existing active infection or serious concurrent illness
• • 6. Any medical or other condition that in the Investigator's opinion renders the patient unsuitable for this study due to unacceptable risk
• • 7. Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
• • 8. Gastrointestinal disorders that may interfere with absorption of the study drug.