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The Clinical Study of the Efficacy and Safety of Trop2-ADC Monotherapy or Combination Immunotherapy Strategy in the Treatment of Advanced Triple-negative Breast Cancer.

ConditionMetastatic Triple-negative Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

This is a prospective, multicenter, randomized controlled study aimed at evaluating the efficacy and safety of Trop2-ADC monotherapy or immune combination strategy in the treatment of advanced triple-negative breast cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1) adult female patients (aged 18-70 years) with metastatic triple negative breast cancer confirmed by pathology or imaging;

2) no more than two previous lines of therapy for metastatic disease;

3) ECOG performance status ≤2 and expected survival time ≥ 3 months;

4) At least one measurable lesion on imaging within 2 weeks before enrollment; Or simple bone metastases;

Disqualifiers

1) patients with a known allergy to the active ingredient or other ingredient of the study drug.

2) patients with known resistance to trop2-ADC drugs. 、

3) receiving radiotherapy, chemotherapy, or endocrine therapy within 4 weeks before enrollment, or participating in any interventional drug clinical trial;

4) pregnant or lactating women or women of childbearing age who refused to use effective contraception during the study period.

Trial design

Design model

Parallel

Treatments tested in this trial

  • trop2-ADC

    Drug

    Accept ADC monotherapy

  • ADC +anti-angiogenic drug

    Drug

    Accept ADC combined with anti-angiogenic drug

  • ADC + PD1 monoclonal antibody +anti-angiogenic drug

    Drug

    ADC combined with PD1 monoclonal antibody and anti-angiogenic drug

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Accept ADC monotherapyActive comparator 1 intervention
Group B: Accept ADC combined with anti-angiogenic drugExperimental treatment 1 intervention
Group C: Receive ADC in combination with PD1 monoclonal antibody and anti-angiogenic drugExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate 3 months after treatment (ORR)

Time frame
Three months after enrollment

Secondary outcomes

1

Overall survival (OS)

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
2

living quality

The scores of EORTC-c30 scale were compared before and after enrollment.

Time frame
"through study completion, an average of 1 year
3

Clinical benefit rate

Time frame
3 months after enrollment

Other outcomes

Sponsors and contacts

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

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Lead sponsor

Source ClinicalTrials.gov
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