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New treatment for advanced triple-negative breast cancer

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)

Phase 3 Interventional Biotheus Inc. · NCT06419621

This study is testing a new treatment called PM8002 combined with Nab-Paclitaxel to see if it helps people with advanced triple-negative breast cancer feel better compared to a placebo with the same chemotherapy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment360 (estimated)
Ages18 Years to 70 Years
SexFemale
SponsorBiotheus Inc. Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations70 sites (Bengbu, Anhui and 69 other locations)
Trial IDNCT06419621 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind study evaluates the safety and efficacy of PM8002 in combination with Nab-Paclitaxel compared to a placebo combined with Nab-Paclitaxel. It targets patients with inoperable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic treatment for advanced disease. The study aims to determine if PM8002 can improve treatment outcomes for these patients.

Who should consider this trial

Good fit: Ideal candidates are females aged 18 to 70 with histologically confirmed unresectable locally advanced or metastatic TNBC.

Not a fit: Patients who have received prior systemic treatment for advanced breast cancer or those with operable disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced triple-negative breast cancer.

How similar studies have performed: Other studies have shown promise in treating triple-negative breast cancer with novel agents, but the specific combination of PM8002 and Nab-Paclitaxel is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Bengbu, Anhui and 69 other locations

+20 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Triple Negative Breast Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.