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Triple Negative Breast Cancer(TNBC)Phase 3NCT06419621

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

A Phase 3 study testing PM8002 and Nab-Paclitaxel in people with Triple Negative Breast Cancer(TNBC), run by Biotheus Inc. at 70 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Triple Negative Breast Cancer(TNBC)
What is being tested?
PM8002 and Nab-Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
392 participants
Where
70 sitesChina
Study dates
11 Jun 2024to Jul 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

70 sites in 1 country.

70 sites in 1 country

China70 sites

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

    Anyang, Henan

  • Affiliated Hospital of Hebei University

    Baoding, Hebei

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

  • Fifth Medical Center of Chinese PLA General Hospital

    Beijing, Beijing Municipality

  • The first affiliated hospital of bengbu medical University

    Bengbu, Anhui

  • Jilin Cancer Hospital

    Changchun, Jilin

  • The First Hospital of Jilin University

    Changchun, Jilin

  • The First People's Hospital of Changde City

    Changde, Hunan

  • Hunan Cancer Hospital

    Changsha, Hunan

  • Sichuan Cancer Hospital

    Chengdu, Sichuan

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • The Southwest Hospital of Army Medical University

    Chongqing, Chongqing Municipality

  • Affiliated Zhongshan Hospital of Dalian University

    Dalian, Liaoning

  • The Second Hospital Of Dalian Medical University

    Dalian, Liaoning

  • The First People's Hospital of Foshan

    Foshan, Guangdong

  • Fujian Provincial Cancer Hospital

    Fuzhou, Fujian

  • Affillated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou, Guangdong

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

    Guangzhou, Guangdong

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

  • The Second Affiliated Hospital Zhejiang University School Of Medicine

    Hangzhou, Zhejiang

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

  • Shandong Cancer Hospital

    Jinan, Shandong

  • Affiliated hospital of Jining Medical University

    Jining, Shandong

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

    Kunming, Yunnan

  • Lanzhou University First Hospital

    Lanzhou, Gansu

  • Linyi Cancer Hospital

    Linyi, Shandong

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan

  • Mianyang Central Hospital

    Mianyang, Sichuan

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi

  • Nanchong Central Hospital of Sichuan Province

    Nanchong, Sichuan

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

  • The Affiliated Hospital of Nantong University

    Nantong, Jiangsu

  • Nanyang Central Hospital

    Nanyang, Henan

  • The First People's Hospital of Neijiang

    Neijiang, Sichuan

  • The Second People's Hospital Of Neijiang

    Neijiang, Sichuan

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

  • Obstetrics and Gynecology Hospital of Fudan University

    Shanghai, Shanghai Municipality

  • Ruijin hospital of Shanghai Jiao Tong university School of Medicine

    Shanghai, Shanghai Municipality

  • Yuebei People's Hospital

    Shaoguan, Guangdong

  • Liaoning Cancer Hospital

    Shenyang, Liaoning

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

  • The First Hospital of China Medical University

    Shenyang, Liaoning

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • Suining Central Hospital

    Suining, Sichuan

  • The Second Affiliated Hospital of Suzhou University

    Suzhou, Jiangsu

  • Shanxi cancer hospital

    Taiyuan, Shanxi

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang

  • Tian Jin Medicial University Cancer Institute&Hospital

    Tianjin, Tianjin Municipality

  • Weifang People's Hospital

    Weifang, Shandong

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

  • Hubei Cancer Hospital

    Wuhan, Hubei

  • Union Hospital Tongji Medical College of Hust

    Wuhan, Hubei

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi

  • Xiangyang Cancer Hospital

    Xiangyang, Hunan

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu

  • The Central Hospital of Yongzhou

    Yongzhou, Hunan

  • Runcheng City Center Hospital

    Yuncheng, Shanxi

  • Henan Cancer Hospital

    Zhengzhou, Henan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: 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)

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)

Being tested
PM8002, Nab-Paclitaxel, Placebo
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PM8002Drug

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

  • Nab-PaclitaxelDrug

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

  • PlaceboDrug

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

Study groups in NCT06419621
Study groupRoleWhat they receive
PM8002 Plus Nab-PaclitaxelExperimentalPatients will receive both PM8002 and Nab-Paclitaxel.
Receives: Drug: PM8002; Drug: Nab-Paclitaxel
Placebo Plus Nab-PaclitaxelPlacebo comparatorPatients will receive both Placebo and Nab-Paclitaxel.
Receives: Drug: Nab-Paclitaxel; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC)

    Progression-free survival is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on assessments by Blinded Independent Review Committee (BIRC) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.

    Measured: Up to approximately 37 months from first patient in

  2. Overall Survival (OS)

    Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis are censored at the date of the last follow-up.

    Measured: Up to approximately 37 months from first patient in

Secondary outcomes (7)

  1. PFS assessed by investigator

    Progression-free survival is defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by investigator or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.

    Measured: Up to approximately 37 months from first patient in

  2. Objective response rate (ORR) assessed by BIRC or investigators

    ORR is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by BIRC or investigators based on RECIST 1.1 is presented.

    Measured: Up to approximately 37 months from first patient in

  3. Disease control rate (DCR) assessed by BIRC or investigators

    DCR is defined as the sum rate of CR, PR and Stable Disease (SD), as determined by BIRC or investigators using RECIST v1.1

    Measured: Up to approximately 37 months from first patient in

  4. Duration of response (DoR) assessed by BIRC or investigators

    DoR is defined as the time period from the date of initial CR or PR until the date of PD or death due to any cause, whichever occurs first.

    Measured: Up to approximately 37 months from first patient in

  5. Incidence and severity of Adverse Event (AE) according to CTCAE 5.0

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

    Measured: Up to 30 days after last treatment

  6. Differences in the scores of health-related quality of life (HRQol) evaluated by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)

    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score are presented.

    Measured: Up to 30 days after last treatment

  7. Differences in the scores of health-related quality of life (HRQol) evaluated by EORTC Quality of Life Questionnaire - Breast Cancer (QLQ-BR42)

    Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score denotes worse symptoms for the systemic therapy side effects symptom scale.

    Measured: Up to 30 days after last treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2024
  2. Study start11 Jun 2024
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
392 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06419621
Sponsor's protocol ID
PM8002-C013C-TNBC-R
Status last verified
Jul 2026
First submitted
14 May 2024
Last updated
29 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data will be published or presented for publications (poster, abstract,articles or papers) or any presentations.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PM8002 and Nab-Paclitaxel in people with Triple Negative Breast Cancer(TNBC), run by Biotheus Inc. at 70 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC) (time frame: Up to approximately 37 months from first patient in). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06419621.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.

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