RecruitingPhase 2Phase 3NCT05860465

Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer

A Phase II/III Study of SPH4336 in Combination With Endocrine Therapy in the Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer That Progressed on CDK4/6 Inhibitor Combined With Endocrine Therapy

Sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Enrollment

254 participants

Start Date

Sep 8, 2023

Study Type

INTERVENTIONAL

Conditions

Locally Advanced or Metastatic Breast Cancer

Summary

This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in the treatment of locally advanced or metastatic breast cancer that progressed on CDK4/6 inhibitor combined with endocrine therapy.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called SPH4336 combined with hormonal (endocrine) therapy in women with advanced or metastatic breast cancer that cannot be surgically removed. The goal is to evaluate safety and effectiveness. **You may be eligible if...** - You have locally advanced or metastatic breast cancer that cannot be treated with surgery - You have at least one measurable tumor - You are in good general health (ECOG 0 or 1) with a life expectancy of at least 3 months - Your organ function (liver, kidneys, blood) is within acceptable levels - You are willing to use effective contraception **You may NOT be eligible if...** - You have inflammatory breast cancer - You have brain metastases - You have a history of another cancer - You are taking Chinese herbal anti-cancer medicines - You have had a recent heart attack, serious heart rhythm problems, or heart failure - 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSPH4336 Tablets

SPH4336 Tablets ：Administered by oral; Letrozole tablets：Administered by oral; Fulvestrant injection：Administered by intravenous infusion

DRUGSPH4336 Tablets Placebo

SPH4336 Tablets Placebo ：Administered by oral; Letrozole tablets：Administered by oral; Fulvestrant injection：Administered by intravenous infusion

Locations(22)

Affiliated Cancer Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Liuzhou people's Hospital

Liuzhou, Guangxi, China

Anyang Cancer Hospital

Anyang, He'nan, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, He'nan, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Harbin Medical University cancer Hospital

Harbin, Heilongjiang, China

Xiangyang Cancer Hospital

Wuhan, Hubei, China

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Jilin Cancer Hospital

Changchun, Jilin, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi’an, Shanxi, China

The second people's hospital of neijiang

Neijiang, Sichuan, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

Zhejiang cancer Hospital

Hangzhou, Zhejiang, China

Peking Union Medical College Hospital

Beijing, China

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

Fujian Cancer Hospital

Fuzhou, China

First Affiliated Hospital of Kunming Medical University

Kunming, China

Shenzhen Hospital of University of Hong Kong

Shenzhen, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05860465

Related Trials

A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy.

NCT073540221 location

A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE)

NCT0668092160 locations

Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer

NCT057446879 locations

A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC

NCT064397711 location

Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer

NCT054303992 locations