Health TrialsbyHealthPanel

A Clinical Study of HRS-6209 Combined With Other Treatment Regimens in Patients With Breast Cancer

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorJiangsu HengRui Medicine Co., Ltd.

About this trial

This is a study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HRS-6209 combined with other treatment regimens in breast cancer patients, and preliminarily observe its anti-tumor efficacy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women aged 18-75 years.

ECOG performance status 0-1.

Menopausal status.

Evidence of radiographic disease progression during or after the last systemic anti-tumor therapy prior to the first study drug administration.

Disqualifiers

Symptomatic visceral metastasis and other conditions, and the researcher judged that endocrine therapy was not suitable for use.

History of clinically serious cardiovascular disease.

The ECG examination was abnormal.

Patients with clinically significant endometrial abnormalities, including but not limited to endometrial hyperplasia and dysfunctional uterine bleeding.

Trial design

Design model

Single group

Treatments tested in this trial

  • HRS-6209 Capsules

    Drug

    Oral HRS-6209 capsules.

  • Letrozole Tablets

    Drug

    Oral Letrozole tablets.

  • HRS-2189 Tablets

    Drug

    HRS-2189 tablets.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: HRS-6209 in Combination with Letrozole GroupExperimental treatment 2 interventions
Group B: HRS-6209 combined with Letrozole and HRS-2189 GroupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity (DLT)

Time frame
28 days after the first dose.
2

Maximum tolerated dose (MTD)

Time frame
28 days after the first dose.
3

Recommended phase II dose (RP2D)

Time frame
28 days after the first dose.
4

Adverse events (AEs)

Time frame
About 1 year.

Secondary outcomes

1

Best overall response (BOR)

Time frame
About 1 year.
2

Duration of response (DoR)

Time frame
About 1 year.
3

Clinical benefit rate (CBR)

Time frame
About 1 year.
4

Progression-free survival (PFS)

Time frame
About 1 year.

Other outcomes

Sponsors and contacts

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

Jiangsu HengRui Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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