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New pill shows promise in slowing advanced breast cancer

NCT ID NCT06301438

Disease control Sponsor: RenJi Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a drug called dalpiciclib in people with a specific type of advanced breast cancer (HR-positive, HER2-negative). The goal is to see how long the drug can keep the cancer from growing and what side effects it causes. About 103 participants will take dalpiciclib as a pill for 21 days on, 7 days off. Researchers will track disease progression and any adverse events.

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 taken as a pill)
What this could lead to
If successful, this study could show that dalpiciclib helps control advanced breast cancer for longer, offering a new treatment option for people with this type of cancer.
What could go wrong
This is a real-world study, not a controlled trial, so results may be less reliable. The drug may not work for everyone and can cause side effects like low blood cell counts or fatigue.

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.

Participants

About 103 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

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.

Who is studied

Hormone receptor-positive and human epidermal growth factor receptor 2-negative advanced breast cancer

Ages

18 years and older

Sex

Anyone

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: * Histologically confirmed advanced breast cancer * Hormone receptor-positive and human epidermal growth factor receptor 2-negative * ECOG 0-1 Exclusion Criteria: * Pregnant or breastfeeding * History of immunodeficiency

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Conditions

The condition(s) this trial relates to.

breast cancer hormone receptor-positive breast cancer

As listed by the trial registrant

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

Advanced breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Renji Hospital, School of Medicine, Shanghai Jiaotong University

    RECRUITING

    Shanghai, 200127, China

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