RecruitingPhase 2NCT06107673

Dalpiciclib Plus AI (Neoadjuvant Endocrine Therapy) Compared With Neoadjuvant Chemotherapy in Early Breast Cancer (EBC)

A Phase II Randomized, Non-inferiority Study Comparing the Efficacy and Safety of Dalpiciclib Combined With AI With Neoadjuvant Chemotherapy in ER+ HER2- Postmenopausal Breast Cancer Patients


Sponsor

Hebei Medical University Fourth Hospital

Enrollment

144 participants

Start Date

Sep 30, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a multi-center, randomized, prospective phase II clinical trial aimed at exploring and evaluating the efficacy of dalpiciclib combined with AI in neoadjuvant treatment for ER strong positive(ER≥50%),HER2-negative, Ki-67≤20%,T1-3N1M0 postmenopausal breast cancer. The primary objectives are to demonstrate non-inferiority in efficacy compared to chemotherapy and to assess its superior safety profile.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing a hormone-based treatment approach (dalpiciclib plus an aromatase inhibitor, given before surgery) against standard chemotherapy as pre-surgical treatment for postmenopausal women with early-stage breast cancer that is strongly estrogen receptor-positive and HER2-negative. The goal is to see if the less toxic hormone approach works just as well as chemotherapy. **You may be eligible if...** - You are a confirmed postmenopausal woman - You have been diagnosed with early invasive breast cancer (stage T1–T3, N1, M0) - Your tumor is strongly estrogen receptor-positive (ER+, ≥ 50% cells) and HER2-negative - You have not had any prior breast cancer treatment - Your heart function is normal (LVEF ≥ 50%) - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have bilateral (both breast) or inflammatory breast cancer - Your cancer has already spread to distant organs (stage IV) - You are pregnant or breastfeeding - You have serious heart conditions (heart failure, recent heart attack, or significant arrhythmias) - You have active serious liver disease or severe HBV/HCV infection - You have a known severe allergy to any study drug component Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDalpiciclib

Dalpiciclib: Take 125 mg once daily for 3 weeks, then stop for 1 week. Each cycle is completed in 4 weeks. It is recommended to take the medication approximately at the same time each day, with warm water, preferably on an empty stomach. Fasting for at least 1 hour before and after medication is advised.

DRUGAromatase inhibitor

AI: Take according to the instructions provided.

DRUGDocetaxel injection

Administered as a 75 mg/m2 intravenous infusion over approximately 30 minutes. It is given every three weeks and dose reduction or treatment delay is allowed, up to a maximum delay of 3 weeks from the previous dose calculation. Treatment will be terminated if the delay exceeds this limit.

DRUGEpirubicin Hydrochloride Injection

Administered as a 75 mg/m2 intravenous infusion. It is given every three weeks and dose reduction or treatment delay is allowed, up to a maximum delay of 3 weeks from the previous dose calculation. Treatment will be terminated if the delay exceeds this limit.

DRUGCyclophosphamide injection

Administered as a 500 mg/m2 intravenous infusion. It is given every three weeks and dose reduction or treatment delay is allowed, up to a maximum delay of 3 weeks from the previous dose calculation. Treatment will be terminated if the delay exceeds this limit.


Locations(1)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

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NCT06107673


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