RecruitingPhase 3NCT06419621

PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC

A Multicenter, Randomized, Double-blind Phase III Study of PM8002 or Placebo in Combination With Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic Triple-negative Breast Cancer(TNBC)

Sponsor

Biotheus Inc.

Enrollment

360 participants

Start Date

Jun 11, 2024

Study Type

INTERVENTIONAL

Conditions

Triple Negative Breast Cancer(TNBC)

Summary

This multicenter, randomized, double-blind study will evaluate the safety and efficacy of PM8002 in combination with Nab-Paclitaxel compared with placebo combined with Nab-Paclitaxel as first-line treatment in inoperable locally advanced/metastatic triple-negative breast cancer(TNBC)

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a new drug called PM8002 — combined with a chemotherapy drug called nab-paclitaxel — works better than chemotherapy alone as a first treatment for triple-negative breast cancer (a type that is harder to treat because it doesn't respond to hormone therapy). **You may be eligible if...** - You are a woman aged 18 to 70 - You have triple-negative breast cancer (ER-, PR-, HER2-negative) confirmed by biopsy - Your cancer cannot be removed with surgery (locally advanced or metastatic) - You have not received prior systemic treatment for advanced breast cancer - You are willing to follow the study schedule **You may NOT be eligible if...** - You have already received chemotherapy or immunotherapy for advanced disease - You have active autoimmune disease or are on immune-suppressing medications - You are pregnant or breastfeeding - You have serious heart, liver, or kidney problems 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

DRUGPM8002

PM8002 20 mg/kg via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle

DRUGNab-Paclitaxel

Nab-Paclitaxel 100mg/m2 via IV infusion on Days 1, 8, and 15 of each 28-day cycle

DRUGPlacebo

Placebo 20 mg/kg via IV infusion on Days 1 and 15 of each 28-day cycle

Locations(70)

The first affiliated hospital of bengbu medical University

Bengbu, Anhui, China

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Fifth Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The Southwest Hospital of Army Medical University

Chongqing, Chongqing Municipality, China

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China

Lanzhou University First Hospital

Lanzhou, Gansu, China

The First People's Hospital of Foshan

Foshan, Guangdong, China

Affillated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, Guangdong, China

Sun Yat-sen Memorial Hospital Affiliated to Sun Yat-sen University

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Yuebei People's Hospital

Shaoguan, Guangdong, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Affiliated Hospital of Hebei University

Baoding, Hebei, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

The Affiliated Anyang Tumor Hospital of Henan University of Science and Technology

Anyang, Henan, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Nanyang Central Hospital

Nanyang, Henan, China

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Union Hospital Tongji Medical College of Hust

Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

The First People's Hospital of Changde City

Changde, Hunan, China

Hunan Cancer Hospital

Changsha, Hunan, China

Xiangyang Cancer Hospital

Xiangyang, Hunan, China

The Central Hospital of Yongzhou

Yongzhou, Hunan, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

The Second Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, China

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Jilin Cancer Hospital

Changchun, Jilin, China

The First Hospital of Jilin University

Changchun, Jilin, China

Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, China

The Second Hospital Of Dalian Medical University

Dalian, Liaoning, China

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Shandong Cancer Hospital

Jinan, Shandong, China

Affiliated hospital of Jining Medical University

Jining, Shandong, China

Linyi Cancer Hospital

Linyi, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Weifang People's Hospital

Weifang, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Ruijin hospital of Shanghai Jiao Tong university School of Medicine

Shanghai, Shanghai Municipality, China

Shanxi cancer hospital

Taiyuan, Shanxi, China

Runcheng City Center Hospital

Yuncheng, Shanxi, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Mianyang Central Hospital

Mianyang, Sichuan, China

Nanchong Central Hospital of Sichuan Province

Nanchong, Sichuan, China

The First People's Hospital of Neijiang

Neijiang, Sichuan, China

The Second People's Hospital Of Neijiang

Neijiang, Sichuan, China

Suining Central Hospital

Suining, Sichuan, China

Tian Jin Medicial University Cancer Institute&Hospital

Tianjin, Tianjin Municipality, China

Yunnan Cancer Hospital (The Third Affiliated Hospital of Kunming Medical University)

Kunming, Yunnan, China

The Second Affiliated Hospital Zhejiang University School Of Medicine

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

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