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Trial Title:
PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic Triple-negative Breast Cancer
NCT ID:
NCT06419621
Condition:
Triple Negative Breast Cancer(TNBC)
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Paclitaxel
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
PM8002
Description:
PM8002 20 mg/kg via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle
Arm group label:
PM8002 Plus Nab-Paclitaxel
Intervention type:
Drug
Intervention name:
Nab-Paclitaxel
Description:
Nab-Paclitaxel 100mg/m2 via IV infusion on Days 1, 8, and 15 of each 28-day cycle
Arm group label:
PM8002 Plus Nab-Paclitaxel
Arm group label:
Placebo Plus Nab-Paclitaxel
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo 20 mg/kg via IV infusion on Days 1 and 15 of each 28-day cycle
Arm group label:
Placebo Plus Nab-Paclitaxel
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)
Criteria for eligibility:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Jian Zhang, professor
Email:
Syner2000@163.com
Start date:
June 11, 2024
Completion date:
July 2028
Lead sponsor:
Agency:
Biotheus Inc.
Agency class:
Industry
Source:
Biotheus Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06419621
