Can an immunotherapy drug boost chemotherapy's power against a tough breast cancer?

NCT ID NCT06419621

Disease control Sponsor: Biotheus Inc. Source: ClinicalTrials.gov ↗

First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether adding an experimental immunotherapy drug called PM8002 to standard chemotherapy (nab-paclitaxel) can help people with advanced triple-negative breast cancer live longer without their disease worsening. The study enrolls women aged 18 to 70 whose cancer cannot be removed by surgery or has spread. Participants receive either PM8002 plus chemotherapy or a placebo plus chemotherapy, and researchers track how long the cancer stays under control and overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: an experimental immunotherapy drug called PM8002 combined with a chemotherapy drug nab-paclitaxel
What this could lead to: If successful, this combination could offer a new first-line treatment option for people with advanced triple-negative breast cancer, potentially slowing disease progression.
What could go wrong: This is an early-phase trial, so the benefits are not yet proven. Immunotherapy can cause immune-related side effects, and the combination may not improve outcomes over standard chemotherapy alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 392 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Ability to understand and willing to provide written informed consent and to comply with scheduled visits and study procedures; * Female, aged 18 to 70 years (inclusive); * Histologically confirmed unresectable locally advanced or metastatic breast cancer with negative status for ER, PR, and HER-2. Testing results for all three markers conducted within 24 months prior to the initiation of the study by a local facility accredited by clinical research center are acceptable. If deemed necessary by the investigator during screening, subjects may provide additional biopsy to confirm the latest pathological; * Subjects who have not received prior systemic treatment（except endocrine therapy） for advanced breast cancer are eligible for the study. Subjects who have received Taxane-based chemotherapy during the neoadjuvant and/or adjuvant treatment phase are eligible, as long as the occurrence of relapse or metastasis is at least 12 months after the end of treatment; * Performance status as assessed by the Eastern Cooperative Oncology Group (ECOG) is 0-1; * Life expectancy of 12 weeks or more; * According to RECIST 1.1, the subject has at least 1 measurable lesion as the targeted lesion (the only bone metastasis or the only central nervous system metastasis should not be considered as a measurable lesion. A measurable lesion located at the previously irradiated radiation field or other local treatment area should not be selected as targeted lesion, unless the lesion shows unequivocal radiographic progression). Exclusion Criteria: * Previous treatment with immune checkpoint agonists (such as CD137 agonists) or immune checkpoint inhibitors (such as CTLA-4, PD-1, PD-L1, LAG3 monoclonal antibody, etc.) or anti-vascular endothelial growth factor (VEGF) target drugs; * Has uncontrolled or symptomatic brain or spine cord metastases; * Those who have had other active malignant tumors within 5 years prior to the study treatment, except for those that can be treated locally and have been cured ; * Poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg); * With a history of hypertensive crisis or hypertensive encephalopathy; * With a history of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess within the last 6 months prior to the start of the study treatment; * Adverse events resulting from prior anti-tumor therapies should be assessed and graded according to the CTCAE 5.0 criteria, subjects whose AEs have not returned to Grade 1 or below; * Has uncontrollable pleural, pericardial, or abdominal effusions; * Has received allogeneic hematopoietic stem cell transplantation or organ transplantation.

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Conditions

The condition(s) this trial relates to.

triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Triple negative breast cancer (TNBC)

Contacts and locations

Locations

Affiliated Hospital of Hebei University

Baoding, Hebei, China
Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, China
Affiliated hospital of Jining Medical University

Jining, Shandong, China
Affillated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, Guangdong, China
Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China
Fifth Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, China
Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China
Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China
Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China
Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China
Henan Cancer Hospital

Zhengzhou, Henan, China
Hubei Cancer Hospital

Wuhan, Hubei, China
Hunan Cancer Hospital

Changsha, Hunan, China
Jiangsu Province Hospital

Nanjing, Jiangsu, China
Jiangxi Cancer Hospital

Nanchang, Jiangxi, China
Jilin Cancer Hospital

Changchun, Jilin, China
Lanzhou University First Hospital

Lanzhou, Gansu, China
Liaoning Cancer Hospital

Shenyang, Liaoning, China
Linyi Cancer Hospital

Linyi, Shandong, China
Mianyang Central Hospital

Mianyang, Sichuan, China
Nanchong Central Hospital of Sichuan Province

Nanchong, Sichuan, China
Nanyang Central Hospital

Nanyang, Henan, China
Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 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
Runcheng City Center Hospital

Yuncheng, Shanxi, China
Shandong Cancer Hospital

Jinan, Shandong, China
Shanxi cancer hospital

Taiyuan, Shanxi, China
Shengjing Hospital of China Medical University

Shenyang, Liaoning, China
Sichuan Cancer Hospital

Chengdu, Sichuan, China
Sichuan Provincial People's Hospital

Chengdu, Sichuan, China
Suining Central Hospital

Suining, Sichuan, China
Sun Yat-sen Memorial Hospital Affiliated to Sun Yat-sen University

Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China
Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China
The Affiliated Anyang Tumor Hospital of Henan University of Science and Technology

Anyang, Henan, China
The Affiliated Hospital of Nantong University

Nantong, Jiangsu, China
The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China
The Central Hospital of Yongzhou

Yongzhou, Hunan, China
The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China
The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China
The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China
The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China
The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China
The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China
The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China
The First Hospital of China Medical University

Shenyang, Liaoning, China
The First Hospital of Jilin University

Changchun, Jilin, China
The First People's Hospital of Changde City

Changde, Hunan, China
The First People's Hospital of Foshan

Foshan, Guangdong, China
The First People's Hospital of Neijiang

Neijiang, Sichuan, China
The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China
The Second Affiliated Hospital Zhejiang University School Of Medicine

Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, China
The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China
The Second Hospital Of Dalian Medical University

Dalian, Liaoning, China
The Second People's Hospital Of Neijiang

Neijiang, Sichuan, China
The Southwest Hospital of Army Medical University

Chongqing, Chongqing Municipality, China
The first affiliated hospital of bengbu medical University

Bengbu, Anhui, China
Tian Jin Medicial University Cancer Institute&Hospital

Tianjin, Tianjin Municipality, China
Union Hospital Tongji Medical College of Hust

Wuhan, Hubei, China
Weifang People's Hospital

Weifang, Shandong, China
Xiangyang Cancer Hospital

Xiangyang, Hunan, China
Xuzhou Central Hospital

Xuzhou, Jiangsu, China
Yuebei People's Hospital

Shaoguan, Guangdong, China
Yunnan Cancer Hospital (The Third Affiliated Hospital of Kunming Medical University)

Kunming, Yunnan, China
Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China
Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

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