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HIM Typing Guides the Treatment of Advanced First-Line Triple-Negative Breast Cancer

ConditionAdvanced Triple Negative Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University

About this trial

To explore the efficacy and safety of treatment for recurrent and metastatic advanced first-line triple-negative breast cancer guided by cell surface protein-based subtyping (HIM).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

More than 18 years old;

ECOG PS Score: 0~1;

Patients must have a life expectancy ≥ 3 months;

Histopathologically confirmed recurrent metastatic triple-negative invasive breast cancer (HER2-negative: IHC 0/1+ or IHC 2+ with negative ISH; ER-negative: IHC <1%, PR-negative: IHC <1%)；

Disqualifiers

Has leptomeningeal metastasis or cystic metastatic lesions confirmed by MRI or lumbar puncture;

Existence of third space fluid (e.g. massive ascites, pleural effusion, pericardial effusion) that is not well controlled by effective methods, e.g.；

Received systemic anti-tumor therapy within 14 days prior to enrollment;

Imaging shows tumor invasion of major blood vessels, or the investigator judges that the tumor is highly likely to invade critical vessels during the study period, leading to life-threatening hemorrhage；

Trial design

Design model

Parallel

Treatments tested in this trial

  • Camrelizumab

    Drug

    PD-1 inhibitor

  • Nab-paclitaxel

    Drug

    chemotherapy

  • SKB264

    Drug

    Trop2-ADC

  • Lenvatinib

    Drug

    Anti-angiogenic TKI

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Cohort A (H subtyping)Experimental treatment 2 interventions
Group B: Cohort B (I subtyping)Experimental treatment 1 intervention
Group C: Cohort C (M subtyping)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

ORR

ORR is the percentage of evaluable patients with a confirmed investigator-assessed target lesion response of CR (complete response) or PR (partial response) per RECIST 1.1

Time frame
at the time point of every 12 weeks, up to one year

Secondary outcomes

1

CBR

CBR is the percentage of evaluable patients with a confirmed investigator-assessed target lesion response of CR (complete response) or PR (partial response) or at least 6 months of SD (stable disease) per RECIST 1.1

Time frame
up to 2 years
2

DoR

DoR is the time from the date of first detection of objective response (which is subsequently confirmed) until the date of objective radiographic disease progression.

Time frame
up to 2 years
3

PFS

PFS is the time from the date of first dose until the date of objective radiographic disease progression or death (by any cause in the absence of progression).

Time frame
up to 2 years
4

OS

OS is the time from the date of first dose until the date of death by any cause.

Time frame
up to 3 years

Other outcomes

Sponsors and contacts

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

Fudan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: