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A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer

ConditionAdvanced Unresectable or Metastatic Breast Cancer of Adults
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorShandong Suncadia Medicine Co., Ltd.

About this trial

This study aims to evaluate the safety, tolerability, efficacy and pharmacokinetics of HRS-6208 in combination with HRS-8080 ± HRS-6209, or in combination with fulvestrant ± HRS-6209, or in combination with letrozole ± HRS-6209 in patients with advanced unresectable or metastatic breast cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female, aged 18-75 (inclusive);

ECOG score 0-1;

Estimated survival time ≥ 12 weeks;

Possessing adequate bone marrow and organ function;

Disqualifiers

Within 5 years prior to the first dose of study medication, the occurrence of other malignancies, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, and post-radical surgery thyroid papillary carcinoma;

Active brain metastasis, carcinomatous meningitis, spinal cord compression, or history of primary central nervous system tumors;

Severe bone damage caused by tumor bone metastasis as determined by the investigator;

Adverse events caused by previous anti-tumor treatment have not been resolved;

Trial design

Design model

Single group

Treatments tested in this trial

  • HRS-6208 Capsule

    Drug

    HRS-6208 capsule.

  • HRS-6209 Capsule

    Drug

    HRS-6209 capsule.

  • HRS-8080 Tablet

    Drug

    HRS-8080 tablet.

  • Fulvestrant injection

    Drug

    Fulvestrant injection.

  • Letrozole tablets

    Drug

    Letrozole tablets.

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Arm A: HRS-6208 + HRS-8080 ± HRS-6209Experimental treatment 3 interventions
Group B: Arm B: HRS-6208 + Fulvestrant ± HRS-6209Experimental treatment 3 interventions
Group C: Arm C: HRS-6208 + Letrozole ± HRS-6209Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity (DLT)

Time frame
The DLT will be evaluated for the last participant in each dose group 28 days after the first dose.
2

Recommended phase II dose (RP2D)

Time frame
The evaluation of RP2D will be completed approximately one year later than DLT evaluation.
3

Incidence and severity of adverse events (AEs)

Time frame
Each individual participant will be followed for approximately 8 months, and the entire study process will last for approximately 36 months.
4

Objective response rate (ORR)

Time frame
For a single subject, the duration will be approximately 8 months, while the entire research process will last for 36 months.

Secondary outcomes

1

Disease control rate (DCR)

Time frame
The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
2

Duration of response (DoR)

Time frame
The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
3

Progression-free survival (PFS)

Time frame
The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
4

Overall survival (OS)

Time frame
The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.

Other outcomes

Sponsors and contacts

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

Shandong Suncadia Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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