- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06009627
Study of Neoadjuvant Endocrine Therapy in HR Positive and HER2 Negative Premenopausal Breast Cancer Patients
Phase II Clinical Study of Darsilide Combined With Exemestane+Goserelin Neoadjuvant Endocrine Therapy in HR Positive and HER2 Negative Premenopausal Breast Cancer Patients
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: xuejing 1 liu, 1
- Phone Number: 19502151516
- Email: lxj8109@126.com
Study Locations
-
-
Tianjin
-
Tianjin, Tianjin, China, 300000
- Recruiting
- Jie Ge
-
Contact:
- xuejing 1 liu, 1
- Phone Number: 19502151516
- Email: lxj8109@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dalcelli+Goserelin+Exemestane
SD patients undergoing 2 cycles of preoperative treatment were randomly assigned to Group A and received darcelli, Exemestane, and Goserelin
|
Dalcelli: 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 |
Active Comparator: Docetaxel, epirubicin hydrochloride, Cyclophosphamide
SD patients undergoing 2 cycles of preoperative treatment were randomly assigned to Group B and received TAC chemotherapy
|
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. 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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
At the end of the second cycle (each cycle is 21 or 28 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor residual load
Time Frame: At the end of the 6 cycle (each cycle is 21 or 28 days)
|
The number of cancer cells, tumor size, or total number of cancer lesions in the human body after surgery
|
At the end of the 6 cycle (each cycle is 21 or 28 days)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breast retention rate
Time Frame: At the end of the 6 cycle (each cycle is 21 or 28 days)
|
Postoperative breast preservation ratio
|
At the end of the 6 cycle (each cycle is 21 or 28 days)
|
Event free lifetime
Time Frame: At the end of the 6 cycle (each cycle is 21 or 28 days)
|
The time from the start of randomized clinical trials to the progression of tumors (in any aspect) or death from any cause
|
At the end of the 6 cycle (each cycle is 21 or 28 days)
|
Overall survival (OS)
Time Frame: 2years
|
Time from randomization to death from any cause
|
2years
|
Collaborators and Investigators
Investigators
- Study Director: jie 1 ge, 1, Yes
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Docetaxel
- Cyclophosphamide
- Epirubicin
- Exemestane
Other Study ID Numbers
- Tianjin Hospital Cancer
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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