BridgeMD
New treatment option for Advanced Unresectable or Metastatic Breast Cancer of Adults
Official title 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
ClinicalTrials.gov ID: NCT07389733
What this study is testing
What is HRS-6208 Capsule?
HRS-6208 Capsule is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced unresectable or metastatic breast cancer of adults.
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
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- Female, aged 18-75 (inclusive);
- ECOG score 0-1;
- Estimated survival time ≥ 12 weeks;
- Possessing adequate bone marrow and organ function;
- Participants of reproductive/childbearing potential must agree to take adequate and effective contraceptive measures from the time they sign the...
You likely can't join if
- Within 5 years prior to the first dose of study medication, the occurrence of other malignancies, except for fully treated cervical carcinoma in...
- 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;
- Participants with one of multiple factors affecting oral medication;
- History of severe cardiovascular and cerebrovascular diseases;
See the full eligibility criteria
- Female, aged 18-75 (inclusive);
- ECOG score 0-1;
- Estimated survival time ≥ 12 weeks;
- Possessing adequate bone marrow and organ function;
- Participants of reproductive/childbearing potential must agree to take adequate and effective contraceptive measures from the time they sign the informed consent form, during the study treatment period, and up to 2...
- Participants must provide informed consent for this study before the trial and voluntarily sign a written informed consent form.
- 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...
- 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;
- Participants with one of multiple factors affecting oral medication;
- History of severe cardiovascular and cerebrovascular diseases;
- Presence of severe infections;
- Significant clinically meaningful bleeding within 3 months prior to the first dose of study medication;
- Active autoimmune diseases, history of immune deficiency, history of autoimmune diseases, or history of diseases or syndromes requiring systemic steroid hormone or immunosuppressive drug treatment, or acquired...
- Active untreated hepatitis;
- History of active tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis infection more than 1 year ago without standard treatment;
- Washout period of prior drug or treatment did not meet protocol requirements before the first dose of study medication;
- Prior use of prohibited drugs specified in the protocol;
- Is pregnant or breastfeeding or planning to become pregnant within 2 years after the last dose of study medication;
- History of clear neurological or psychiatric disorders, and participants with a history of psychiatric drug abuse or drug addiction;
- Allergic reactions to any study drug or excipients;
- Factors confirmed by the investigator as unsuitable for participation in this clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Dalian, Liaoning, China
- Chengdu, Sichuan, China
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 female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dalian, Liaoning, China; Chengdu, Sichuan, China. 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.