NCT04113863 (ATRA) is a Phase 2 clinical trial of all-trans retinoic acid in Breast Neoplasm Female, sponsored by Mario Negri Institute for Pharmacological Research.

Who is sponsoring NCT04113863?

NCT04113863 is sponsored by Mario Negri Institute for Pharmacological Research.

What drugs are being tested in NCT04113863?

Interventions in NCT04113863: all-trans retinoic acid, Anastrozole 1mg.

What condition does NCT04113863 study?

NCT04113863 studies Breast Neoplasm Female.

Is NCT04113863 still recruiting?

NCT04113863 is currently terminated. Last updated 18 December 2025.

Last reviewed 2025-12-18 · How we verify

NCT04113863: ATRA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 2 Last updated 18 December 2025

What this trial tests

Phase 2 trial testing all-trans retinoic acid in Breast Neoplasm Female in 76 participants. Terminated before completion.

Timeline

18 June 2019

Primary endpoint
30 January 2025

30 January 2025

Quick facts

Lead sponsor	Mario Negri Institute for Pharmacological Research
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	76
Start date	18 June 2019
Primary completion	30 January 2025
Estimated completion	30 January 2025
Sites	2 locations across Italy

Drugs / interventions tested

all-trans retinoic acid
Anastrozole 1mg — full drug profile →

Conditions studied

Breast Neoplasm Female — all drugs for Breast Neoplasm Female →

Sponsor

Mario Negri Institute for Pharmacological Research

Who can join

Adults 18 to 75, female only, with Breast Neoplasm Female. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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, differentiating and apoptotic effects through the nuclear retinoic acid receptors, including RARα (retinoic acid receptor alpha). Although the clinical use of ATRA in haematological malignancies (Acute Promyelocytic Leukemia, APL) is well established, its use in solid tumors is limited. However, some recent pre-clinical evidence suggests a possible role of ATRA in the treatment of specific subtypes of HR-positive (Hormonal Receptor)/HER2-negative early breast cancer (eBC). Moving from pre-clinical evidence and given the well-known retinoid mechanism of action, The hypotheses is that ATRA contributes to tumor regression in a specific sub-population of eBCs. Using a preoperative "window-of-opportunity" model, aimed at testing the activity of ATRA in combination with anastrozole in postmenopausal women with newly diagnosed, resectable, HR+/HER2- eBCs.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of all-trans retinoic acid

Trials testing the same drug.

NCT06528769 — Study of All-Trans Retinoic Acid (ATRA) and Cemiplimab in Patients With Advanced Leiomyosarcoma · Phase 2 · recruiting
NCT05438875 — The Combination of ATRA and Eltrombopag as the Treatment of Steroid-resistant/Relapse ITP Based on MSC-C5b-9 · Phase 3 · completed
NCT05497310 — Effectiveness and Safety of Therapy Based on Attenuated ATO Plus Low-Dose ATRA in Patients With APL · Phase 1, PHASE2 · unknown
NCT03031249 — Efficacy and Safety of ATO Plus ATRA in Nucleophosmin-1 Mutated Acute Myeloid Leukemia · Phase 1, PHASE2 · enrolling by invitation
NCT02899169 — Treatment of Non-high-risk Acute Promyelocytic Leukemia (APL) With Realgar-Indigo Naturalis Formula (RIF) · Phase 3 · unknown

Other recruiting trials for Breast Neoplasm Female

Currently open trials in the same condition.

NCT07465523 — A Novel Approach in the Evaluation of Breast Masses With Doppler US · recruiting
NCT06711523 — Study Evaluating PEG-G-CSF Injectionin Preventing Neutropenia After Chemotherapy · Phase 3 · active not recruiting
NCT05277935 — Wearable Enhanced Fitness Tracking for Metastatic Breast Cancer Patients Using Endocrine Treatment and Palbociclib · NA · recruiting
NCT06234137 — A Prospective, Open, Multicenter Single-arm Clinical Studie of Docetaxel, Carboplatin Combined With Inetetamab and Pyrot · NA · recruiting
NCT04812652 — Digitally Distributed Yoga for Women Treated for Breast Cancer · NA · active not recruiting

Other Mario Negri Institute for Pharmacological Research trials

Trials by the same sponsor.

NCT07428018 — Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Onco · Phase 2 · not yet recruiting
NCT07331103 — RESOLving INflammation Through Diet for Health (RESOLVIN) · NA · recruiting
NCT06994468 — Effect of B-cell Depleting Therapies on PLA2R-specific B Cells in Patients With Membranous Nephropathy · NA · completed
NCT07111624 — A New Crowding Indicator in the Emergency Department · not yet recruiting
NCT07021118 — Mild TBI in the Emergency Department · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04113863 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mario Negri Institute for Pharmacological Research
Last refreshed: 18 December 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04113863.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing