Health TrialsbyHealthPanel

SBRT Combined With PD-1 Inhibitor and Chemotherapy in Early-stage TNBC

ConditionTNBC - Triple-Negative Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorWest China Hospital

About this trial

Triple-negative breast cancer (TNBC) presents significant challenges due to its limited treatment options and poor efficacy. While neoadjuvant chemotherapy has improved breast-conserving rates and extended survival for TNBC patients, this subtype still faces issues such as restricted treatment modalities, low pathological response rates, and unfavorable prognosis compared to other subtypes. Studies like Keynote522 and IMpassion031 have shown that combining chemotherapy with immunotherapy yields a pCR rate of 64.8% in early-stage high-risk TNBC patients, suggesting that such combinations can offer substantial benefits. However, the low immunogenicity of breast cancer and the lack of clear predictive molecular markers for effective immunotherapy result in suboptimal pCR and objective response rates for this group. Radiotherapy has systemic immune regulatory effects by promoting the release of antigens from tumor cells, enhancing T-cell infiltration, and directly killing tumor cells. Therefore, this study aims to investigate the efficacy and safety of stereotactic radiotherapy combined with PD-1 inhibitors and chemotherapy in the neoadjuvant treatment of TNBC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Histologically or cytologically confirmed TNBC (ER-, PR-, HER2-)

2. cT1cN1-2M0 or cT2N0-2M0；（AJCC 7th）

3. ECOG performance status of 0-1;

4. Adequate bone marrow function, defined as: Hb ≥ 9.0 g/dL (90 g/L); ANC ≥ 1,500/mcL (1.5 × 10^9/L); PLT ≥ 100,000/mcL (100 × 10^9/L) and no blood transfusion within 3 weeks or growth factor (G-CSF, EPO) therapy within 2 weeks prior to dosing;

Disqualifiers

1. Patients with a history of mental illness or those diagnosed with mental disorders at the time of enrollment in the clinical trial.

2. Patients with communication barriers due to confusion, aphasia, intellectual disability, or other reasons that prevent them from responding normally.

3. Poorly controlled tumor-related pain.

4. Patients participating in other clinical studies simultaneously.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SBRT+PD-1 Inhibitor + Chemotherapy

    Drug

    Radiotherapy: 24Gy/3f, once every other day; Chemotherapy: Cycles 1-4: Albumin-bound paclitaxel: 260 mg/m², IV, administered on day 1 of each cycle; Carboplatin AUC=5, IV, administered on day 1 of each cycle. Cycles 5-8: Epirubicin: 90-100 mg/m², IV, administered on day 1 of each cycle; Cyclophosphamide: 600 mg/m², IV, administered on day 1 of each cycle; Immunotherapy: PD-1 inhibitor, once every three weeks

  • PD-1 Inhibitor + Chemotherapy

    Drug

    Chemotherapy: Cycles 1-4: Albumin-bound paclitaxel: 260 mg/m², IV, administered on day 1 of each cycle; Carboplatin AUC=5, IV, administered on day 1 of each cycle. Cycles 5-8: Epirubicin: 90-100 mg/m², IV, administered on day 1 of each cycle; Cyclophosphamide: 600 mg/m², IV, administered on day 1 of each cycle; Immunotherapy: PD-1 inhibitor, once every three weeks

Treatment groups

318 Participants
are divided into 2 treatment groups
Group A: SBRT+PD-1 Inhibitor + ChemotherapyExperimental treatment 1 intervention
Group B: PD-1 Inhibitor + ChemotherapyPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

pCR

The percentage of patients showing no evidence of invasive cancer cells in the tissue samples after treatment

Time frame
The time immediately after the complete surgery

Secondary outcomes

1

Breast conservation rate

The percentage of patients undergoing breast-conserving surgery

Time frame
3 year
2

Ipsilateral breast recurrence or local regional recurrence

The percentage of patients experiencing a recurrence of cancer in the same breast or in the nearby lymph nodes

Time frame
3 year
3

Overall survival

The period from the start of treatment until the occurrence of death.

Time frame
3 year
4

The incidence of adverse events

The safety

Time frame
Up to approximately 1 year

Other outcomes

Sponsors and contacts

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

West China Hospital

Lead sponsor

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

Collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Collaborator

Shandong Cancer Hospital and Institute

Collaborator

Source ClinicalTrials.gov
Apply now