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Tests treatment safety and results for Breast Cancer
Official title A Trial of HRS-6209-205 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Combination Therapy in Subjects With HR-Positive/HER2-Negative Cancer
ClinicalTrials.gov ID: NCT07358377
What this study is testing
What is HRS-6209 Capsules and fulvestrant injection?
HRS-6209 Capsules and fulvestrant injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Subjects with HR-Positive/HER2-Negative solid tumor.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
- Adequate bone marrow and other vital organ functions
- Adequate liver function tests
- HR-positive or HER2-negative solid tumor patients
You likely can't join if
- Plan to receive any other anti-tumor therapy during the study.
- Active brain metastases .
- Have poorly controlled or severe cardiovascular disease, including (1) congestive heart failure.
- Previous use of fulvestrant
- clinically significant endometrial abnormalities, including but not limited to endometrial hyperplasia and dysfunctional uterine bleeding.
- With uncontrollable chronic systemic complications (such as severe chronic lung, liver, kidney, or heart disease).
See the full eligibility criteria
- Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
- Adequate bone marrow and other vital organ functions
- Adequate liver function tests
- HR-positive or HER2-negative solid tumor patients
- Plan to receive any other anti-tumor therapy during the study.
- Active brain metastases .
- Have poorly controlled or severe cardiovascular disease, including (1) congestive heart failure.
- Previous use of fulvestrant
- clinically significant endometrial abnormalities, including but not limited to endometrial hyperplasia and dysfunctional uterine bleeding.
- With uncontrollable chronic systemic complications (such as severe chronic lung, liver, kidney, or heart disease).
- With acute or active tuberculosis infection requiring medication.
- Pregnant or lactating women, or females planning to become pregnant During the study.
- Known history of clinically significant liver disease, untreated active hepatitis (hepatitis B, defined as hepatitis B virus surface antigen [HBsAg] or hepatitis B core antibody [HBcAb] positive
The study team makes the final eligibility decision.
Where it's taking place
- Elizabeth Vale, South Australia, Australia
- Ballarat, Victoria, Australia
- Frankston, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Elizabeth Vale, South Australia, Australia; Ballarat, Victoria, Australia; Frankston, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.