Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Triple Negative Breast Neoplasms

Recurrence

Breast Diseases

Skin Diseases

Participants receive Cadonilimab 10mg/kg IV on Day 1 of each 21-day cycle PLUS Eribulin 1.4mg/m\^2 IV on Days 1 and 8 of each 21-day cycle.

Participants receive Eribulin 1.4mg/m\^2 IV on Days 1 and 8 of each 21-day cycle.

Cadonilimab

Eribulin

Nan Niu

Nan Niu, Phd

The purpose of this study is to assess the efficacy and safety of Cadonilimab (AK104) plus Eribulin compared to the efficacy and safety of Eribulin monotherapy in the treatment of adult patients with recurrent, or metastatic triple negative breast cancer.

The primary study hypothes is that the combination of Cadonilimab (AK104) plus Eribulin is superior to Eribulin monotherapy with respect to Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator.

Study of Cadonilimab (AK104) Plus Eribulin vs. Eribulin Monotherapy for Recurrent or Metastatic Triple-negative Breast Cancer

A Multicenter, Randomized, Controlled, Open Label Clinical Study on the Treatment of Recurrent or Metastatic Triple Negative Breast Cancer With Cadonilimab Combined With Eribulin Versus Eribulin Alone

PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator will be presented.

OS is defined as the time from randomization to death due to any cause.

ORR is defined as the percentage of the participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters).

For participants who demonstrate CR or PR, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death. The DOR per RECIST 1.1 as assessed by Investigator will be presented.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be presented.

An SAE is defined as any untoward medical occurrence that, at any dose: a.) Results in death; b.) Is life-threatening; c.) Requires inpatient hospitalization or prolongation of existing hospitalization; d.) Results in persistent or significant disability/incapacity; e.) Is a congenital anomaly/birth defect; f.) Other important medical events; h.) Is a new cancer (that is not a condition of the study) or i.) Is associated with an overdose. The number of participants who experience an SAE will be presented.

AEs associated with Cadonilimab exposure may be a result of an immune response. These irAEs may occur shortly after the first dose or several months after the last dose of Cadonilimab treatment and may affect more than one body system simultaneously. For this study irAEs include, but are not limited to:

Pneumonitis; Diarrhea/Colitis; Aspartate transaminase (AST)/Alanine transaminase (ALT) elevation or Increased bilirubin; Type 1 diabetes mellitus or Hyperglycemia; Hypophysitis; Hyperthyroidism; Hypothyroidism; Nephritis and Renal dysfunction; and Myocarditis. The number of participants who experience an irAE will be presented.

Spots Global Cancer Trial Database for Study of Cadonilimab (AK104) Plus Eribulin vs. Eribulin Monotherapy for Recurrent or Metastatic Triple-negative Breast Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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