New drug combo aims to keep early breast cancer from returning

NCT ID NCT07581834

Recruiting now Disease control Sponsor: Fujian Cancer Hospital Source: ClinicalTrials.gov ↗

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

Summary

This study is testing whether adding the drug dalpiciclib to standard hormone therapy can help prevent breast cancer from coming back in women with early-stage HR+/HER2- breast cancer. About 2,000 women will receive either a higher dose for 2 years or a lower dose for 3 years, along with hormone therapy. Researchers will track how long women live without their cancer returning and monitor side effects.

What this could mean

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

Active substance: Dalpiciclib (a CDK4/6 inhibitor) combined with endocrine therapy (letrozole, anastrozole, or exemestane)
What this could lead to: If successful, this could offer a new adjuvant treatment option that lowers the risk of breast cancer returning in women with early-stage HR+/HER2- disease.
What could go wrong: This is a phase 2 trial, so results are still preliminary. The two different doses and durations are being compared, and side effects like low blood cell counts may occur. It is not yet proven to be better than current standard care.

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

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Conditions

The condition(s) this trial relates to.

breast disorder 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 DISEASES BREAST NEOPLASMS CDK4/6 INHIBITOR DALPICICLIB ENDOCRINE BREAST DISEASES HR+/HER2- BREAST CANCER

Contacts and locations

Locations

Fujian Cancer Hosptial
RECRUITING

Fuzhou, Fujian, 350001, China
West China Hospital of Sichuan University
NOT_YET_RECRUITING

Chengdu, Sichuan, 618099, China

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