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Could a leukemia drug help fight breast cancer? new trial investigates

NCT ID NCT04113863

Disease control Sponsor: Mario Negri Institute for Pharmacological Research Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding a drug called ATRA (all-trans retinoic acid) to the standard hormone therapy anastrozole could shrink tumors more effectively in postmenopausal women with a common type of early breast cancer (HR-positive/HER2-negative). The trial was planned for 76 participants and took place before their scheduled surgery. The study was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

76 people

The number who actually took part.

Started

Jun 2019

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast neoplasm female

Contacts and locations

Locations

  • ASST Papa Giovanni XXIII

    Bergamo, 24127, Italy

  • Ospedale Santa Maria della Misericordia di Udine

    Udine, UD, 33100, Italy

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