A Study of HS-10342 in Chinese Patients With HR+/HER2- Advanced and/or Metastatic Breast Cancer

Browse trials for

• Breast Neoplasms 12,544

Keywords

• Advanced and/or Metastatic Breast Cancer
• HR+/HER2-
• CDK4/6
• HS-10342

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 20 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Lead sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd. is the lead sponsor of 131 studies on the registry; 70 are open to participants now.

Study arms

• Experimental
  HS-10342

  Each subject will receive repeat doses (C1, C2...) for 28-day cycles. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria is met.

  Drug: HS-10342

Interventions

• DrugHS-10342

  HS-10342 tablet once daily from Day 1 to 21 of a 28-day cycle

Primary outcomes

1. Percentage of Participants With Complete Response (CR) or Partial Response (PR)（Objective response rate [ORR]）

   ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.

   Time frame: Up to approximately 12 months

Secondary outcomes

1. Overall Survival (OS)

   OS defined as the time from first dose date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.

   Time frame: From Date of the First Dose until Death Due to Any Cause (Up To 24 Months)

2. Duration of Response (DOR)

   DOR was the time from the date of first evidence of CR or PR to the date of objective progression or the date of death due to any cause, whichever is earlier.

   Time frame: From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 12 Months)

3. Progression Free Survival (PFS)

   PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.

   Time frame: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 24 Months)

4. Percentage of Participants With CR, PR or SD

   Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.

   Time frame: Disease Control Rate [DCR]) [ Time Frame: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 12 Months)