Neoadjuvant endocrine therapy for 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

This study is testing if a new combination of medications can help premenopausal women with certain types of breast cancer improve their condition after chemotherapy.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 119 (estimated)
• Ages: 18 Years to 100 Years
• Sex: Female
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Tianjin, Tianjin)
• Trial ID: NCT06009627 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of Darxil combined with Exemestane and goserelin as neoadjuvant endocrine therapy in premenopausal women with HR positive and HER2 negative breast cancer. The study is designed as a multicenter, prospective, open, randomized cohort trial, focusing on patients who have stable disease after two cycles of neoadjuvant chemotherapy. The primary endpoint is the objective response rate (ORR) of the treatment, with a planned recruitment of 119 participants to assess the efficacy of the intervention.

Who should consider this trial

Good fit: Ideal candidates are premenopausal women with operable HR positive and HER2 negative invasive breast cancer who have stable disease after initial chemotherapy.

Not a fit: Patients with HER2 positive breast cancer or those who do not meet the inclusion criteria for operability or disease stage may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could improve treatment outcomes for premenopausal women with HR positive and HER2 negative breast cancer.

How similar studies have performed: Other studies have shown promise with similar neoadjuvant endocrine therapy approaches, indicating potential for success in this trial.

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

Where this trial is running

Tianjin, Tianjin

• Jie Ge — Tianjin, Tianjin, China (Recruiting)

Study contacts

• Study coordinator: xuejing 1 liu, 1

Conditions Breast Cancer