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New combo therapy shows promise for premenopausal breast cancer patients

NCT ID NCT06009627

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested whether adding the drug darsilide to standard hormone therapy (exemestane and goserelin) can shrink tumors in premenopausal women with HR-positive, HER2-negative breast cancer. The 119 participants had not responded fully to initial chemotherapy. The main goal was to see how many patients had a significant reduction in tumor size before surgery.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

119 people

The number who actually took part.

Started

Apr 2023

Finished

Sep 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 100 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: * All patients were operable estrogen receptor (ER) positive (\>1%), regardless of PR expression level, HER2 receptor negative invasive breast cancer. Follow the 2018 ASCO-CAP HER2 negative interpretation guideline standard. Confirmed by the pathological laboratory that the immunohistochemical (IHC) score is 0 or 1-2+and the in situ hybridization (ISH) test is negative (ISH amplification rate\<2.0); * Stage II-III initial treatment patients whose tumor staging meets the AJCC 8th edition standards; * At least one measurable breast and/or axillary disease; * ECOG 0-1, with an estimated lifespan of at least 12 months; * The functional level of the main organs must meet the following requirements: Blood routine: ANC ≥ 1.5 × ten9/L; PLT ≥ 90 × ten9/L; Hb ≥ 90 g/L;Blood biochemistry: TBIL ≤ 2.5 × ULN; ALT and AST ≤ 2.5 × ULN; BUN and Cr≤ 1.5 × ULN; * Lead ECG: QT interval (QTcF) corrected by Fridericia method\<470 ms for women; * Able to accept all puncture biopsies required by the protocol; * Volunteer to join this study, sign informed consent, have good compliance, and be willing to cooperate with follow-up; * Women with fertility potential must have a negative Pregnancy test (urine or serum) within 7 days after administration, And agree to use acceptable birth control methods during the study period to avoid pregnancy. Exclusion Criteria: * Received any form of anti-tumor treatment within 28 days prior to the start of the study; * Simultaneously receiving any anti-tumor treatment beyond the provisions of other protocols; * Bilateral breast cancer, inflammatory breast cancer or occult breast; * Stage IV breast cancer; * Severe dysfunction of important organs such as heart, liver, and kidney; * Unable to swallow, chronic diarrhea and Bowel obstruction, there are many factors that affect drug taking and absorption; * Participated in other drug clinical trials within 4 weeks prior to enrollment; * Those with a known history of allergies to the drug components of this protocol; Have a history of immunodeficiency, including positive Diagnosis of HIV/AIDS test Sex, HCV, active hepatitis B, or other acquired or congenital immunodeficiency diseases Illness or a history of organ transplantation; * Have ever suffered from any heart disease, including: (1) arrhythmia that requires medication or has clinical significance

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Jie Ge

    Tianjin, Tianjin Municipality, 300000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.