New combo therapy shows promise for premenopausal breast cancer patients
NCT ID NCT06009627
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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119 people
The number who actually took part.
- Started
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Apr 2023
- Finished
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Sep 2025
- Lead sponsor
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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
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18 to 100 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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
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Jie Ge
Tianjin, Tianjin Municipality, 300000, China
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