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SBRT, Chemotherapy, and AK104 Neoadjuvant Therapy for Triple-negative Breast Cancer (TNBC)

NCT06401005 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2024-12-02

No results posted yet for this study

Summary

Studies have indicated that the improvement in pathological complete response (pCR) is significantly correlated with triple-negative breast cancer（TNBC）patients' overall survival (OS). Patients with TNBC have poor efficacy for neoadjuvant chemotherapy. The combination of neoadjuvant therapy with immunotherapy and chemotherapy has been demonstrated to enhance the pCR rate of TNBC patients, increasing it from 45% to approximately 60%. Therefore, how to further improve the pCR rate of TNBC breast cancer became the main objective of this study. Stereotactic radiotherapy (SBRT) not only kills tumor cells directly, but also kills the distant unirradiated tumor cells by promoting the cross-initiation of tumor-specific CD8+ T cells, a phenomenon known as the abscopal effect. Our research team has recently discovered that the triple therapy model of SBRT + anti-vascular targeting + anti-PD-1 was safe and efficacious in lung cancer patients. Cadonilimab (AK104) is an PD-1/CTLA-4 bispecific antibody. In order to improve the pCR, a single-arm, open, phase II clinical study was proposed to explore the safety and efficacy of SBRT+AK104+chemotherapy, a neoadjuvant treatment modality, in the treatment of TNBC.

Conditions

Interventions

DRUG

Cadonilimab (AK104)

8Gy\*3 SBRT to irradiate the primary lesion (without axillary lymph node metastasis) or 6Gy\*3 SBRT irradiation to irradiate the primary lesion and axillary lymph node metastasis will be administered at first. And then the first cycle of chemotherapy+AK104 given within 24 hours of the end of SBRT. The total eight cycles of preoperative chemotherapy combined with immunotherapy were administered. Surgical resection was performed within 4-6 weeks after the completion of the eighth cycle of chemotherapy combined with immunotherapy. The chemotherapy regimen consisted of: Four cycles of doxorubicin 50mg/m2 (Q3W) + cyclophosphamide 600mg/m2 (Q3W) were administered, followed by four cycles of sequential albumin paclitaxel (125 mg/m2, d1, d8) and carboplatin (AUC=6, d1, Q3W) for 4 cycles. Postoperative completion of 9 cycles of immunotherapy was continued ± the need for postoperative adjuvant radiotherapy was confirmed based on the patient's preoperative status.

Sponsors & Collaborators

  • Hubei Cancer Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-28
Primary Completion
2026-08-31
Completion
2027-09-01

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06401005 on ClinicalTrials.gov