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

ConditionTriple Negative Breast Cancer(TNBC)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorBiotheus Inc.

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • PM8002

    Drug

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

  • Nab-Paclitaxel

    Drug

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

  • Placebo

    Drug

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

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: PM8002 Plus Nab-PaclitaxelExperimental treatment 2 interventions
Group B: Placebo Plus Nab-PaclitaxelPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
Up to approximately 37 months from first patient in

Secondary outcomes

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.

Time frame
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.

Time frame
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

Time frame
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.

Time frame
Up to approximately 37 months from first patient in

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biotheus Inc.

Lead sponsor

Source ClinicalTrials.gov
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