RecruitingPhase 3NCT05814354

SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial

A Randomized, Open, Parallel-controlled, Multicenter Phase III Trial of SHR-A1811 Versus Investigator Chemotherapy in HER2-low Expressing Recurrent/Metastatic Breast Cancer


Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

530 participants

Start Date

Jun 30, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this study was to evaluate whether the progression-free survival of SHR-A1811 was superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer. To evaluate whether SHR-A1811 is superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing SHR-A1811 — a new antibody-drug conjugate targeting HER2 — to standard chemotherapy chosen by the doctor for women with HER2-low hormone receptor-positive metastatic breast cancer that no longer benefits from hormone therapy. **You may be eligible if...** - You have breast cancer with low HER2 expression (IHC 2+/ISH-negative or IHC 1+) - Your cancer is hormone receptor-positive but has stopped responding to hormone therapy - You have had 0–1 prior lines of chemotherapy for metastatic disease - Your cancer has measurable, progressing disease on imaging - You are in adequate overall health **You may NOT be eligible if...** - You have HER2-negative (IHC 0) or HER2-high (overexpressing) breast cancer - You have had 2 or more prior lines of chemotherapy for metastatic breast cancer - You are still responding to hormone therapy - You have uncontrolled brain metastases 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

DRUGSHR-A1811

SHR-A1811 is a lyophilized powder for injection intravenously. Administered according to label, as one option for Physician's Choice.

DRUGCapecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel

Administered according to label, as one option for Physician's Choice (determined before randomization).


Locations(1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

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NCT05814354


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