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New treatment option for Triple Negative Breast Cancer(TNBC)
Official title PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC
ClinicalTrials.gov ID: NCT06419621
What this study is testing
What is PM8002?
PM8002 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for triple negative breast cancer(tnbc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join if
- 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...
- people who have not received prior systemic treatment（except endocrine therapy） for advanced breast cancer are eligible for the study. people who...
- Performance status as assessed by the Eastern Cooperative Oncology Group (ECOG) is 0-1;
You likely can't join if
- Previous treatment with immune checkpoint agonists (such as CD137 agonists) or immune checkpoint inhibitors (such as CTLA-4, PD-1, PD-L1, LAG3...
- 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...
- 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...
See the full eligibility 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...
- people who have not received prior systemic treatment（except endocrine therapy） for advanced breast cancer are eligible for the study. people who have received Taxane-based chemotherapy during the neoadjuvant and/or...
- 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...
- 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)...
- 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, people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bengbu, Anhui, China
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Lanzhou, Gansu, China
- Foshan, Guangdong, China
- Guangzhou, Guangdong, China
- Shaoguan, Guangdong, China
- Nanning, Guangxi, China
- Baoding, Hebei, China
- Shijiazhuang, Hebei, China
- Harbin, Heilongjiang, China
- Anyang, Henan, China
- Luoyang, Henan, China
- Nanyang, Henan, China
- Xinxiang, Henan, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changde, Hunan, China
+ 31 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bengbu, Anhui, China; Hefei, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Lanzhou, Gansu, China and 45 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.