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A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer.

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRisen (Suzhou) Pharma Tech Co., Ltd.

About this trial

This study is a randomised, open-label, multicentre phase III clinical study evaluating the efficacy and safety of JS105 combined with Dalpiciclib and Fulvestrant compared with Dalpiciclib and Fulvestrant in patients with PIK3CA-mutated, HR-positive, HER2-negative recurrent or metastatic breast cancer.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

At the time of signing the consent form, age must be between 18 and 75 years old, males and females;

Patients with unresectable PIK3CA-mutated HR-positive HER2-negative recurrent or metastatic breast cancer;

Consent to provide tumour tissue or blood samples to determine the PIK3CA mutation status;

ECOG 0 or 1;

Disqualifiers

Previously treated with fulvestrant or PI3K/AKT/mTOR inhibitors;

Presence of untreated or active central nervous system (CNS) metastases;

Presence of significant clinical symptoms or uncontrolled pleural effusion, ascites, or pericardial effusion that require repeated drainage (once a month or more frequently);

Untreated spinal cord compression, or previously treated spinal cord compression without clinical evidence of disease stability for at least 4 weeks prior to the first study treatment;

Trial design

Design model

Parallel

Treatments tested in this trial

  • JS105

    Drug

    Patients will receive oral JS105 on Days 1-28 of each 4-week cycle.

  • Dalpiciclib

    Drug

    Patients will receive oral Dalpiciclib for 3 weeks, followed by 1 week off in each 4-week cycle；

  • Fulvestrant 50 Mg/mL Intramuscular Solution

    Drug

    Patients will receive intramuscular Fulvestrant on day 1 and day 15 of the first cycle and then on day 1 of each subsequent 4-week cycle.

Treatment groups

312 Participants
are divided into 2 treatment groups
Group A: JS105+Dalpiciclib+FulvestrantExperimental treatment 3 interventions
Group B: Dalpiciclib+FulvestrantActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Blind Independent Central Review (BICR) assessed PFS based on RECIST v1.1 (BICR-PFS)

PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first).

Time frame
Up to 3.5 years

Secondary outcomes

1

Overall Survival (OS)

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

Time frame
Up to 5 years
2

Investigator-assessed Progression-Free Survival (PFS)

PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first).

Time frame
Up to 3.5 years
3

1-year and 2-year Progression-Free Survival (PFS) rate

1-year and 2-year Progression-Free Survival (PFS) rate

Time frame
Up to 3.5 years
4

Objective Response Rate (ORR)

Objective Response Rate (ORR) as Assessed by Investigator or BICR according to RECIST v1.1

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

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

Risen (Suzhou) Pharma Tech Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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