Targeted pill combo could spare some breast cancer patients from chemo

NCT ID NCT04158362

Ongoing Disease control Sponsor: UNICANCER Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jul 23, 2026 · Updated 3 times

Summary

This phase 3 trial tests whether a combination of the targeted drug abemaciclib plus hormone therapy works as well as standard chemotherapy for women with ER+ HER2- breast cancer that has spread to the liver, lungs, or other organs. About 180 participants will be randomly assigned to one of the two approaches. The main goal is to see how long the cancer stays under control, while also tracking quality of life.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Abemaciclib (a targeted cancer pill) combined with hormone therapy (letrozole or anastrozole)
What this could lead to: If successful, this could show that a targeted pill plus hormone therapy works as well as or better than chemotherapy for people with advanced ER+ HER2- breast cancer that has spread to organs, potentially offering a less toxic first treatment option.
What could go wrong: This is a phase 3 trial, but it is still experimental. The combination may not improve progression-free survival compared to chemo, and side effects like diarrhea, fatigue, or blood clots are possible. Results may not apply to all patients.

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Conditions

The condition(s) this trial relates to.

breast carcinoma breast neoplasm estrogen-receptor positive breast cancer hormone receptor-positive breast cancer metastatic malignant neoplasm Neoplasm Metastasis

As listed by the trial registrant

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

CANCER METASTATIC

Contacts and locations

Locations

Centre Eugène Marquis

Rennes, France
Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

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