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

NCT06009627 | Completed Phase 2

• 1 other identifier: Tianjin Hospital Cancer
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  At the end of the second cycle (each cycle is 21 or 28 days)

Secondary Outcomes (1)

• Tumor residual load

  At the end of the 6 cycle (each cycle is 21 or 28 days)

Other Outcomes (3)

• Breast retention rate

  At the end of the 6 cycle (each cycle is 21 or 28 days)

• Event free lifetime

  At the end of the 6 cycle (each cycle is 21 or 28 days)

• Overall survival (OS)

  2years

Study Arms (2)

dalpiciclib+Goserelin+Exemestane

EXPERIMENTAL

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

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

Drug: Docetaxel for injection、Epirubicin hydrochloride for injection、Cyclophosphamide for injection

Interventions

Docetaxel for injection、Epirubicin hydrochloride for injection、Cyclophosphamide for injection DRUG

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

Docetaxel, epirubicin hydrochloride, Cyclophosphamide

dalpiciclib、Exemestane、Gosserine DRUG

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

dalpiciclib+Goserelin+Exemestane

Eligibility Criteria

• Age: 18 Years - 100 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Jie Ge

Tianjin, Tianjin Municipality, 300000, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Injections

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• jie 1 ge, 1

  yes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 24, 2023
• Study Start: April 11, 2023
• Primary Completion: March 11, 2025
• Study Completion: September 11, 2025
• Last Updated: February 10, 2026

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)