Breast CancerPhase 2/3NCT06009627
Study of Neoadjuvant Endocrine Therapy in HR Positive and HER2 Negative Premenopausal Breast Cancer Patients
A Phase 2/3 study testing dalpiciclib、Exemestane、Gosserine and Docetaxel for injection、Epirubicin hydrochloride for injection、Cyclophosphamide for injection in people with Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
A multicenter, prospective, open, randomized cohort, non controlled phase II clinical study to evaluate the effectiveness and safety of Darxil combined with Exemestane+goserelin neoadjuvant endocrine therapy in HR positive and HER2 negative premenopausal breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- dalpiciclib、Exemestane、Gosserine and Docetaxel for injection、Epirubicin hydrochloride for injection、Cyclophosphamide for injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2023to 11 Sep 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Clinical Study of Darsilide Combined With Exemestane+Goserelin Neoadjuvant Endocrine Therapy in HR Positive and HER2 Negative Premenopausal Breast Cancer Patients
A multicenter, prospective, open, randomized cohort, non controlled phase II clinical study to evaluate the effectiveness and safety of Darxil combined with Exemestane+goserelin neoadjuvant endocrine therapy in HR positive and HER2 negative premenopausal breast cancer patients. The study object was to evaluate the HR positive and HER2 negative premenopausal breast cancer patients with SD after 2 cycles of neoadjuvant chemotherapy. The main endpoint was the objective response rate (ORR) of treatment
Read the detailed description
A multicenter, prospective, open, randomized cohort, non controlled phase II clinical study to evaluate the effectiveness and safety of Darxil combined with Exemestane+goserelin neoadjuvant endocrine therapy in HR positive and HER2 negative premenopausal breast cancer patients. The study object was to evaluate the HR positive and HER2 negative premenopausal breast cancer patients with SD after 2 cycles of neoadjuvant chemotherapy. The main endpoint was the objective response rate (ORR) of treatment。Objective: To evaluate the efficacy and safety of darsilide combined with endocrine therapy in SD patients with HR positive and HER2 negative premenopausal breast cancer after 2 cycles of neoadjuvant chemotherapy. It is planned to recruit 119 HR positive and HER2 negative premenopausal breast cancer patients in Group A to conduct the trial with Simon's two-stage design. The null hypothesis is a true response rate of 0.2, while the alternative hypothesis is a true response rate of 0.4. The experiment was conducted in two stages. In the first stage, 13 patients were enrolled. If there are ≤ 3 responses in 13 patients, the study will be stopped Early stopping. Otherwise, continue30 patients were enrolled, with a total sample size of 43. If there are ≥ 13 patients responding, the treatment is effective. Group B was randomly assigned in a 1:1 ratio, with the same number of participants as Group A, resulting in 43 final participants. Calculated based on the proportion of SD patients in 2 cycles of neoadjuvant chemotherapy accounting for 80%, and considering a 10% dropout rate, the final enrollment was made The sample size is 119 cases. The actual samples for molecular testing can be randomly selected based on clinical efficacy, with a statistically significant number.
- Conditions
- Breast Cancer
- Being tested
- dalpiciclib、Exemestane、Gosserine, Docetaxel for injection、Epirubicin hydrochloride for injection、Cyclophosphamide for injection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dalpiciclib、Exemestane、GosserineDrug
dalpiciclib: once a day, 125 mg each time, taken for 3 weeks, stopped for 1 week, 1 for 4 weeks
Period. It is recommended to take the medication at approximately the same time every day, delivered in warm water, on an empty stomach, at least before taking the medication
Fasting for 1 hour before and after.
Exemestane: 25mg, oral, once a day, continuous administration.
Gosserine: 3.6mg, subcutaneous injection, once every four weeks, continuous administration
Docetaxel for injection、Epirubicin hydrochloride for injection、Cyclophosphamide for injectionDrug
Docetaxel for injection: 75mg/m2, intravenous drip, approximately 30 minutes. Dose reduction and delayed administration are allowed every three weeks, with a maximum of three weeks of delayed administration allowed since the last administration time
Calculate, otherwise terminate treatment.
- Epirubicin hydrochloride for injection: 75mg/m2, intravenous drip. Once every three weeks, allowing for dose reduction
And delayed administration, with a maximum allowable delay of 3 weeks, calculated from the last administration time. Otherwise
Stop treatment.
- Cyclophosphamide for injection: 500mg/m2, intravenous drip. Once every three weeks, allowing for dose reduction and
Delayed administration, allowed up to 3 weeks, calculated from the last administration time, otherwise terminated treat
| Study group | Role | What they receive |
|---|---|---|
| dalpiciclib+Goserelin+Exemestane | Experimental | SD patients undergoing 2 cycles of preoperative treatment were randomly assigned to Group A and received darcelli, Exemestane, and Goserelin Receives: Drug: dalpiciclib、Exemestane、Gosserine |
| Docetaxel, epirubicin hydrochloride, Cyclophosphamide | Active comparator | SD patients undergoing 2 cycles of preoperative treatment were randomly assigned to Group B and received TAC chemotherapy Receives: Drug: Docetaxel for injection、Epirubicin hydrochloride for injection、Cyclophosphamide for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) for treatment
The proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit requirement
Measured: At the end of the second cycle (each cycle is 21 or 28 days)
Secondary outcomes (1)
Tumor residual load
The number of cancer cells, tumor size, or total number of cancer lesions in the human body after surgery
Measured: At the end of the 6 cycle (each cycle is 21 or 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start11 Apr 2023
- Primary completion11 Mar 2025
- Study completion11 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jie 1 ge, 1, Study director, yes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009627
- Sponsor's protocol ID
- Tianjin Hospital Cancer
- Status last verified
- Jul 2023
- First submitted
- 18 Jul 2023
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of Darsilide Combined With Exemestane+Goserelin Neoadjuvant Endocrine Therapy in HR Positive and HER2 Negative Premenopausal Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06009627
- Acronym / sponsor ID
- Tianjin Hospital Cancer
- Conditions
- Breast Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 11 Mar 2025 (actual)
- Study completion
- 11 Sep 2025 (actual)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, prospective, open, randomized cohort, non controlled phase II clinical study to evaluate the effectiveness and safety of Darxil combined with Exemestane+goserelin neoadjuvant endocrine therapy in HR positive and HER2 negative premenopausal breast cancer patients. The study object was to evaluate the HR positive and HER2 negative premenopausal breast cancer patients with SD after 2 cycles of neoadjuvant chemotherapy. The main endpoint was the objective response rate (ORR) of treatment
Detailed description
A multicenter, prospective, open, randomized cohort, non controlled phase II clinical study to evaluate the effectiveness and safety of Darxil combined with Exemestane+goserelin neoadjuvant endocrine therapy in HR positive and HER2 negative premenopausal breast cancer patients. The study object was to evaluate the HR positive and HER2 negative premenopausal breast cancer patients with SD after 2 cycles of neoadjuvant chemotherapy. The main endpoint was the objective response rate (ORR) of treatment。Objective: To evaluate the efficacy and safety of darsilide combined with endocrine therapy in SD patients with HR positive and HER2 negative premenopausal breast cancer after 2 cycles of neoadjuvant chemotherapy. It is planned to recruit 119 HR positive and HER2 negative premenopausal breast cancer patients in Group A to conduct the trial with Simon's two-stage design. The null hypothesis is a true response rate of 0.2, while the alternative hypothesis is a true response rate of 0.4. The experiment was conducted in two stages. In the first stage, 13 patients were enrolled. If there are ≤ 3 responses in 13 patients, the study will be stopped Early stopping. Otherwise, continue30 patients were enrolled, with a total sample size of 43. If there are ≥ 13 patients responding, the treatment is effective. Group B was randomly assigned in a 1:1 ratio, with the same number of participants as Group A, resulting in 43 final participants. Calculated based on the proportion of SD patients in 2 cycles of neoadjuvant chemotherapy accounting for 80%, and considering a 10% dropout rate, the final enrollment was made The sample size is 119 cases. The actual samples for molecular testing can be randomly selected based on clinical efficacy, with a statistically significant number.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dalpiciclib+Goserelin+Exemestane | Experimental | Drug: dalpiciclib、Exemestane、GosserineSD patients undergoing 2 cycles of preoperative treatment were randomly assigned to Group A and received darcelli, Exemestane, and Goserelin |
| Docetaxel, epirubicin hydrochloride, Cyclophosphamide | Active comparator | Drug: Docetaxel for injection、Epirubicin hydrochloride for injection、Cyclophosphamide for injectionSD patients undergoing 2 cycles of preoperative treatment were randomly assigned to Group B and received TAC chemotherapy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dalpiciclib、Exemestane、Gosserinedalpiciclib: once a day, 125 mg each time, taken for 3 weeks, stopped for 1 week, 1 for 4 weeks Period. It is recommended to take the medication at approximately the same time every day, delivered in warm water, on an empty stomach, at least before taking the medication Fasting for 1 hour before and after. Exemestane: 25mg, oral, once a day, continuous administration. Gosserine: 3.6mg, subcutaneous injection, once every four weeks, continuous administration | Drug | dalpiciclib+Goserelin+Exemestane |
| Docetaxel for injection、Epirubicin hydrochloride for injection、Cyclophosphamide for injectionDocetaxel for injection: 75mg/m2, intravenous drip, approximately 30 minutes. Dose reduction and delayed administration are allowed every three weeks, with a maximum of three weeks of delayed administration allowed since the last administration time Calculate, otherwise terminate treatment. 5. Epirubicin hydrochloride for injection: 75mg/m2, intravenous drip. Once every three weeks, allowing for dose reduction And delayed administration, with a maximum allowable delay of 3 weeks, calculated from the last administration time. Otherwise Stop treatment. 6. Cyclophosphamide for injection: 500mg/m2, intravenous drip. Once every three weeks, allowing for dose reduction and Delayed administration, allowed up to 3 weeks, calculated from the last administration time, otherwise terminated treat | Drug | Docetaxel, epirubicin hydrochloride, Cyclophosphamide |
Primary outcome
Objective response rate (ORR) for treatment
Time frame: At the end of the second cycle (each cycle is 21 or 28 days)
The proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit requirement
1 secondary outcome
Tumor residual load
Time frame: At the end of the 6 cycle (each cycle is 21 or 28 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jie 1 ge, 1 study director
yes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing dalpiciclib、Exemestane、Gosserine and Docetaxel for injection、Epirubicin hydrochloride for injection、Cyclophosphamide for injection in people with Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) for treatment (time frame: At the end of the second cycle (each cycle is 21 or 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.