Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer

Triple-negative Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06367088
• Other study ID #: Sophia
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2024
• Est. completion date: April 30, 2027

Study information

• Verified date: March 2024
• Source: Wuhan Union Hospital, China
• Contact: Jie Xiong, PhD
• Phone: +86-15927611872
• Email: xxiongjie2000[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The prognosis of recurrent and metastatic triple negative breast cancer (TNBC) is poor, and chemotherapy is still the main treatment for TNBC. Some studies have shown that combination therapy of antibodies targeting cytotoxic T-lymphocyte antigen-4 (CTLA-4) and programmed cell death-1 (PD-1) significantly improves clinical benefit over PD-1 antibody alone. However, broad application of this combination has been limited by toxicities. Cadonilimab is a humanized immunoglobulin G1 bispecific antibody targeting PD-1 and CTLA-4. It mutates to eliminate Fc receptor and complement-mediated cytotoxic effects. The purpose of this study is to evaluate the efficacy and safety of Cadonilimab combined with chemotherapy as a first or second-line treatment of recurrent and metastatic TNBC. This study is a multicenter, single arm, phase II, non randomized, open label, Simon two-stage design. It is planned to enroll 27 late stage TNBC patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: April 30, 2027
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Recurrent or metastatic TNBC patients;
• TNBC defined by immunohistochemistry as ER<1%, PR<1%, Her2=0~1+, or 2+ while HER2 Fish test shows no amplification;
• Previous received no or only first line chemotherapy treatment for recurrent or metastatic TNBC;When the time between cancer metastasis and the end of adjuvant chemotherapy exceeds 1 year, the systemic chemotherapy for metastasis treatment is recorded as first-line treatment; When less than 1year, the systemic chemotherapy for metastasis treatment is recorded as second-line treatment;
• ages 18 to 75 years at the time of signing the informed consent form (ICF);
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
• expected survival of =3 months; at least one measurable lesion per RECIST (version1.1);
• acceptable renal and liver function;

Exclusion Criteria:

• They had received ICIs (i.e., anti-PD-1 antibodies, anti-PD-L1 antibodies, and anti-CTLA-4 antibodies.);
• Patients with active central nervous system (CNS) metastatic lesions or meningeal metastases;
• Patients with an active autoimmune disease that requires systemic treatment in the past two years;
• A known history of primary immunodeficiency;
• Pregnant or lactating women;
• Previous or current abnormalities of any disease, treatment, laboratory tests may confuse the study results, affect the subject's participation in the study

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Neoplasms
• Triple-negative Breast Cancer

Intervention

Drug:
• Cadonilimab
Patients were assigned to receive 10 mg/kg cadonilimab intravenously Q3W in combination with chemotherapy. The chemotherapy regimen is chosen by the physician.

Locations

Country	Name	City	State
China	Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Progression-free survival	Progression-free survival is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first.	Up to 2 years
Other	Overall survival	Overall survival is defined as the time from the start of treatment with AK104 until death due to any cause.	Up to 2 years
Other	Disease control rate	The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for =8 weeks) based on RECIST Version 1.1.	Up to 2 years
Primary	Objective Response Rate	The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.	Up to 2 years
Secondary	AE	An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.	From the time of informed consent signed through 90 days after the last dose of drug