RecruitingPhase 2NCT06176534

Combination Followed by Maintenance Chemotherapy Versus CDK4/6 Inhibitor Combined With Endocrine Therapy for HR Low/HER2-negative Advanced Breast Cancer: a Prospective, Randomized, Open-label Phase Ⅱ Clinical Trial


Sponsor

Henan Cancer Hospital

Enrollment

240 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To observe the differences in the efficacy of Combination followed by maintenance chemotherapy versus CDK4/6 inhibitor combined with endocrine therapy in HR low expression /HER2 negative advanced breast cancer, and to provide new evidence for the best treatment of HR low expression /HER2 negative advanced breast cancer, and to explore the efficacy and safety of combined/maintenance chemotherapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two treatment strategies for advanced breast cancer that has low levels of hormone receptors (HR-low) and is HER2-negative: chemotherapy (given in combination and then as maintenance) versus a CDK4/6 inhibitor drug combined with hormone therapy — to find out which approach works better for this hard-to-treat subgroup. **You may be eligible if...** - You are 18 or older with metastatic breast cancer confirmed by biopsy - Your tumor is HER2-negative and has low hormone receptor (estrogen receptor) expression of 1-50% - You have at least one measurable lesion on imaging - You have not yet had chemotherapy for your metastatic disease **You may NOT be eligible if...** - Your tumor is HER2-positive or has no hormone receptor expression at all (unless certain criteria are met) - You have had prior chemotherapy for metastatic (stage IV) disease - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding 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

DRUGExperimental: chemotheyapy

nab-paclitaxel 130mg/m2,day 1 and day 8 + Capecitabine 2000mg/m2, followed by nab-paclitaxel 130mg/m2,day 1 and day 8 or Capecitabine from day1 to DAY 14 Vinorelbine 25mg/m2,day 1 and day 8 + Capecitabine 2000mg/m2,from day1 to DAY 14

DRUGActive Comparator: endocrine therapy

palbociclib 125mg per day for 21days Dalpiciclib 150mg per day for 21days Letrozole 2.5mg per day Anastrozole 1mg per day fulvestrant 500mg per 28 days


Locations(1)

Henan Breast Cancer Center, The Affiliated Cancer Hospital of Zhengzhou University

Zhengzhou, Henan, China

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NCT06176534


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