Status:
TERMINATED
Evaluation of ATRA Activity in Combination With Anastrozole in Pre-operative Phase of Operable Early Breast Cancer
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Conditions:
Breast Neoplasm Female
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
This is an Italian, single center, randomized, phase II study. ATRA (all-trans retinoic acid) and derivatives (retinoids) are promising anticancer agents and exert their anti-proliferative, differenti...
Detailed Description
This is an Italian, single center, randomized, phase II study. ATRA (all-trans retinoic acid) and derivatives (retinoids) are promising anticancer agents and exert their anti-proliferative, differenti...
Eligibility Criteria
Inclusion
- Signed, informed consent
- Histologically confirmed non-metastatic operable primary invasive HR-positive breast cancer subjected to diagnostic core biopsy
- Menopausal status
- 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
- Available paraffin-embedded tumor block (FFPE) taken at diagnostic biopsy for Ki67 determination (IHC)
- Adequate bone marrow, hepatic and renal function including the following:
- Hb ≥ 9.0 g/dL, absolute neutrophil count ≥ 1.5 x 109/L, platelets ≥100 x 109/L
- Total bilirubin ≤ 1.5 x upper normal limit, excluding cases where elevated bilirubin can be attributed to Gilberts Syndrome
- AST (SGOT), ALT (SGPT) ≤ 2.5 x upper normal limit (or 5x UNL in the presence of liver metastases)
- Creatinine ≤ 1.5 x upper normal limit
- Age ≥ 18 years
- Performance status (PS) ≤ 1 (ECOG scale)
Exclusion
- Presence of metastatic disease
- Pre-menopausal status
- Previous investigational treatment for any condition within 4 weeks of randomization date
- Treatment including radiation therapy, chemotherapy, biotherapy and/or hormonal therapy for the currently diagnosed breast cancer prior to study entry
- Co-existing active infection or serious concurrent illness
- Any medical or other condition that in the Investigator's opinion renders the patient unsuitable for this study due to unacceptable risk
- Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
- Gastrointestinal disorders that may interfere with absorption of the study drug.
Key Trial Info
Start Date :
June 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2025
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT04113863
Start Date
June 18 2019
End Date
January 30 2025
Last Update
December 18 2025
Active Locations (2)
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1
Ospedale Santa Maria della Misericordia di Udine
Udine, UD, Italy, 33100
2
ASST Papa Giovanni XXIII
Bergamo, Italy, 24127