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Study of Neoadjuvant Endocrine Therapy in HR Positive and HER2 Negative Premenopausal Breast Cancer Patients

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Dalcelli、Exemestane、Gosserine
Docetaxel for injection、Epirubicin hydrochloride for injection、Cyclophosphamide for injection
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Jie GeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dalcelli+Goserelin+Exemestane

Docetaxel, epirubicin hydrochloride, Cyclophosphamide

Arm Description

SD patients undergoing 2 cycles of preoperative treatment were randomly assigned to Group A and received darcelli, Exemestane, and Goserelin

SD patients undergoing 2 cycles of preoperative treatment were randomly assigned to Group B and received TAC chemotherapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Tumor residual load
The number of cancer cells, tumor size, or total number of cancer lesions in the human body after surgery

Full Information

First Posted
July 18, 2023
Last Updated
August 20, 2023
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06009627
Brief Title
Study of Neoadjuvant Endocrine Therapy in HR Positive and HER2 Negative Premenopausal Breast Cancer Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2023 (Actual)
Primary Completion Date
March 11, 2025 (Anticipated)
Study Completion Date
September 11, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
119 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dalcelli+Goserelin+Exemestane
Arm Type
Experimental
Arm Description
SD patients undergoing 2 cycles of preoperative treatment were randomly assigned to Group A and received darcelli, Exemestane, and Goserelin
Arm Title
Docetaxel, epirubicin hydrochloride, Cyclophosphamide
Arm Type
Active Comparator
Arm Description
SD patients undergoing 2 cycles of preoperative treatment were randomly assigned to Group B and received TAC chemotherapy
Intervention Type
Drug
Intervention Name(s)
Dalcelli、Exemestane、Gosserine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Docetaxel for injection、Epirubicin hydrochloride for injection、Cyclophosphamide for injection
Intervention Description
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
Primary Outcome Measure Information:
Title
Objective response rate (ORR) for treatment
Description
The proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit requirement
Time Frame
At the end of the second cycle (each cycle is 21 or 28 days)
Secondary Outcome Measure Information:
Title
Tumor residual load
Description
The number of cancer cells, tumor size, or total number of cancer lesions in the human body after surgery
Time Frame
At the end of the 6 cycle (each cycle is 21 or 28 days)
Other Pre-specified Outcome Measures:
Title
Breast retention rate
Description
Postoperative breast preservation ratio
Time Frame
At the end of the 6 cycle (each cycle is 21 or 28 days)
Title
Event free lifetime
Description
The time from the start of randomized clinical trials to the progression of tumors (in any aspect) or death from any cause
Time Frame
At the end of the 6 cycle (each cycle is 21 or 28 days)
Title
Overall survival (OS)
Description
Time from randomization to death from any cause
Time Frame
2years

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xuejing 1 liu, 1
Phone
19502151516
Email
lxj8109@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jie 1 ge, 1
Organizational Affiliation
yes
Official's Role
Study Director
Facility Information:
Facility Name
Jie Ge
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xuejing 1 liu, 1
Phone
19502151516
Email
lxj8109@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Neoadjuvant Endocrine Therapy in HR Positive and HER2 Negative Premenopausal Breast Cancer Patients

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