Study of Radiotherapy Combined With Cisplatin/Carboplatin, Adebrelimab and Bevacizumab in the Treatment of TNBC-BM.

ConditionsTNBC, Triple Negative Breast Cancer Brain Metastasases

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-70

SponsorFudan University

About this trial

This is an open-label, prospective, two-arm, multicenter phase II clinical trial. The aim is to explore the efficacy and safety of radiotherapy combined with cisplatin/carboplatin, adebrelimab, and bevacizumab in patients with triple-negative breast cancer and brain metastases.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years and ≤70 years, gender not limited;

ECOG score 0-2;

Pathologically confirmed HR-negative/HER2-negative breast cancer patients with evidence of local recurrence or metastasis, unsuitable for curative surgical resection or radiotherapy; HR-negative is defined as ER-negative and PR-negative, with positive tumor cells accounting for <10% of all tumor cells;

Must not have previously used platinum-based drugs, or must have previously used platinum-based drugs (cisplatin or carboplatin and only one regimen) and meet the following definition of platinum sensitivity: no progression during at least 4 cycles of platinum-based therapy, and subsequent disease progression occurring more than 3 months after the last platinum-based therapy;

Disqualifiers

Leptomeningeal metastases or cystic metastases confirmed by MRI or lumbar puncture;

Presence of third-space effusion (e.g., massive pleural effusion and ascites) that cannot be controlled by drainage or other methods;

Received whole-brain radiotherapy, chemotherapy, or surgery within 2 weeks prior to treatment with the investigational drug, or received endocrine therapy within one week prior to treatment;

Previous use of bevacizumab and PD-1/PD-L1 inhibitors, excluding the following: no disease progression during bevacizumab and PD-1/PD-L1 inhibitor use, investigators believe no drug resistance has been confirmed, and continued use would benefit the subject; short-term bevacizumab use to relieve cerebral edema;

Trial design

Design model

Parallel

Treatments tested in this trial

Radiation Therapy
Radiation
Patients will receive either Fractionated Stereotactic Radiotherapy (FSRT) or Whole Brain Radiotherapy (WBRT), at the discretion of the treating physician based on the number, size, and location of brain metastases.
Adebelimab
Drug
20mg/kg, IV, D1, Q3W
Bevacizumab
Drug
7.5mg/kg, IV, D1, Q3W
Cisplatin or carboplatin
Drug
Cisplatin 75mg/m2, IV, D1, Q3W; or carboplatin: AUC=5, IV, D1, Q3W

Treatment groups

58 Participants

are divided into 2 treatment groups

Group A: Radiotherapy followed by systemic therapy groupExperimental treatment 4 interventions

Group B: Systemic therapy followed by radiotherapy groupExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

12-month CNS-PFS rate

The 12-month CNS-PFS rate was used for intracranial efficacy assessment based on RANO-BM, and extracranial efficacy assessment based on RECIST 1.1.

Time frame

From randomization up to 12 months.

Secondary outcomes

CNS ORR

ntracranial objective response rate is defined as the proportion of patients who achieve a best overall intracranial response of complete response (CR) or partial response (PR), as assessed by RANO-BM criteria.

Time frame

Up to 24 months(Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12)

CNS CBR

Clinical benefit rate is defined as the proportion of patients who achieve a best overall intracranial response of complete response (CR), partial response (PR), or stable disease (SD) lasting for at least 24 weeks, as assessed by RANO-BM criteria.

Time frame

Up to 24 months (Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12)

ORR

Objective response rate is defined as the proportion of patients who achieve a best overall response of complete response (CR) or partial response (PR)

Time frame

Up to 24 months (Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12)

CBR

clinical benefit rate is defined as the proportion of patients who achieve a best overall response of complete response (CR), partial response (PR), or stable disease (SD) lasting for at least 24 weeks.

Time frame

Up to 24 months (Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12)

Other outcomes

Exploratory Biomarker Analysis

Tumor tissue (≥10 unstained slides or fresh tissue specimens), blood (8 mL of clotted blood, 8 mL of anticoagulated blood), cerebrospinal fluid (8 mL), urine (20 mL ), and stool samples (5 g) will be collected for exploratory cytological and multi-omics analyses to identify biomarkers associated with treatment response and resistance to radiotherapy combined with systemic therapy.

Time frame

At baseline, after Cycle 2 (each cycle is 21 days), and at disease progression or treatment discontinuation (up to 24 months)

Sponsors and contacts

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Fudan University

Lead sponsor

Source ClinicalTrials.gov

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