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Retlirafusp Alfa Combined With Chemotherapy or Fuzuloparib for Triple-Negative Breast Cancer

ConditionTriple-Negative Breast Cancer (TNBC)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-100
SponsorHarbin Medical University

About this trial

To investigate the efficacy and safety of Retlirafusp alfa in combination with chemotherapy or fluzoparib for early-stage and advanced triple-negative breast cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years, female;

Histopathologically confirmed recurrent or metastatic triple-negative breast cancer, defined as ER-negative (IHC ER-positive percentage <1%), PR-negative (IHC PR-positive percentage <1%), and HER2-negative (IHC -/+ or IHC ++ but FISH/CISH -);

At least one measurable lesion per RECIST version 1.1 criteria;

Life expectancy ≥3 months;

Disqualifiers

Concurrently receiving anti-tumor therapy in another clinical trial;

Received other anti-tumor therapy within 4 weeks prior to the first dose of study drug;

Prior treatment with tumor immunotherapy (including but not limited to PD-1, PD-L1, CTLA-4 inhibitors, etc.) or TGF-β inhibitors;

Prior treatment with PARP inhibitors (except for patients who completed PARP inhibitor therapy for ovarian cancer ≥5 years ago with no recurrence or metastasis);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Retlirafusp alfa+Nab-paclitaxel:

    Drug

    Retlirafusp alfa+Nab-paclitaxel

  • Retlirafusp alfa+Fluzoparib

    Drug

    Retlirafusp alfa+Fluzoparib

  • Retlirafusp alfa+TP-AC

    Drug

    Retlirafusp alfa+TP-AC

  • Retlirafusp alfa+Fluzoparib

    Drug

    Retlirafusp alfa+Fluzoparib

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Advanced cohort: gBRCA1/2 wild-typeExperimental treatment 1 intervention
Group B: Advanced cohort: gBRCA1/2 pathogenic or likely pathogenic mutationExperimental treatment 1 intervention
Group C: Early neoadjuvant cohort: gBRCA1/2 wild-typeExperimental treatment 1 intervention
Group D: Early neoadjuvant cohort: gBRCA1/2 pathogenic or likely pathogenic mutationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Late-Stage Cohort-Objective Response Rate

Proportion of patients with best overall response of complete response (CR) or partial response (PR) from treatment initiation to disease progression.

Time frame
Assessed every 6 weeks (every 2 cycles) during treatment until disease progression, death, or loss to follow-up. Analysis cutoff at 6 months.
2

Neoadjuvant Cohort-tpCR (ypT0/is ypN0)

Pathologic complete response with no residual invasive carcinoma in breast and ipsilateral lymph nodes after neoadjuvant therapy and surgery.

Time frame
Surgery performed 2-6 weeks after completing 8 cycles (≈24 weeks) of neoadjuvant therapy; pathological assessment post-surgery. Analysis cutoff at 6 months.

Secondary outcomes

1

Late-Stage Cohort-Disease Control Rate

Proportion of patients with best overall response of CR, PR, or stable disease (SD) from treatment initiation to disease progression.

Time frame
Assessed every 6 weeks (every 2 cycles) during treatment until disease progression, death, or loss to follow-up. Analysis cutoff at 6 months.
2

Late-Stage Cohort-Clinical Benefit Rate

Proportion of patients with confirmed CR, PR, or SD lasting ≥24 weeks.

Time frame
Assessed until disease progression, death, or loss to follow-up. Analysis cutoff at 6 months.
3

Late-Stage Cohort-Progression-Free Survival

Time from treatment initiation to first radiographic disease progression or death from any cause.

Time frame
Assessed every 3 months during treatment and follow-up until disease progression, death, or start of subsequent anticancer therapy. Analysis cutoff at 36 months.
4

Late-Stage Cohort-Overall Survival

Time from treatment initiation to death from any cause.

Time frame
Follow-up every 3 months via clinic visit or telephone call after treatment completion until death or study end. Analysis cutoff at 36 months.

Other outcomes

Sponsors and contacts

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

Harbin Medical University

Lead sponsor

Source ClinicalTrials.gov

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