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New treatment option for Advanced ER+/HER2- Breast Cancer
Official title Phase Ib/II Clinical Study of QLS1304 Combined With Endocrine Therapy in the Treatment of ER+/HER2- Breast Cancer Patients
ClinicalTrials.gov ID: NCT07235176
What this study is testing
What is QLS1304 tablet+Fulvestrant or QLC1401?
QLS1304 tablet+Fulvestrant or QLC1401 is an investigational medicine, being studied as a potential treatment for advanced er+/her2- 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
- This study is a multi-center, open label, phase Ib/II clinical trial aimed at evaluating the safety, preliminary efficacy characteristic and PK characteristics of QLS1304 in combined with endocrine therapy in ER+/HER2- breast cancer patients. This study was divided into two stages: combo dose escalation and dose expansion.
- 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 and older
You may be able to join if
- Volunteer to participate in this study, sign an informed consent form and have good compliance;
- Age ≥ 18 years old, Male or female
- ECOG score: 0-1
- Expected survival ≥ 12 weeks
- Local recurrent or metastatic advanced ER+/HER2- breast cancer confirmed by histopathology or cytopathology;
You likely can't join if
- people have received live or attenuated live vaccines within 4 weeks before the first use of the investigational drug.
- people have undergone major organ surgery within 4 weeks before the first use of the investigational drug.
- people require long-term or high-dose use of non-steroidal drugs.
- people have not recovered from adverse events (AEs) caused by previous anti-tumor treatment to ≤ grade 1.
- people have a known or suspected severe allergy to the investigational drug or any of its components.
- people have other active malignant tumors within 3 years before the first use of the investigational drug.
See the full eligibility criteria
- Volunteer to participate in this study, sign an informed consent form and have good compliance;
- Age ≥ 18 years old, Male or female
- ECOG score: 0-1
- Expected survival ≥ 12 weeks
- Local recurrent or metastatic advanced ER+/HER2- breast cancer confirmed by histopathology or cytopathology;
- Failed to at least one therapy line of endocrine therapy ;
- Baseline presence of at least one measurable lesion according to the RECIST v1.1;
- The functional level of important organs is basically normal, meeting the requirements of the scheme;
- Female people with fertility and male people must agree to use highly effective contraception during the study treatment period and within 180 days after the last medication;
- Female people with fertility must have a negative serum HCG test within 7 days before the first medication in the study, and must be in non lactation.
- Volunteer to participate in this clinical trial, willing and able to follow the procedures related to clinical visits and research, understand the research procedures, and have signed informed consent.
- people have received live or attenuated live vaccines within 4 weeks before the first use of the investigational drug.
- people have undergone major organ surgery within 4 weeks before the first use of the investigational drug.
- people require long-term or high-dose use of non-steroidal drugs.
- people have not recovered from adverse events (AEs) caused by previous anti-tumor treatment to ≤ grade 1.
- people have a known or suspected severe allergy to the investigational drug or any of its components.
- people have other active malignant tumors within 3 years before the first use of the investigational drug.
- people have brain metastases and/or carcinomatous meningitis or leptomeningeal disease.
- people have active tuberculosis, radiation pneumonitis, drug-induced pneumonitis, pulmonary fibrosis, or other diseases, symptoms, or signs of severe lung function impairment.
- people are unable to swallow tablets or had gastrointestinal abnormalities that the investigator assessed as potentially affecting drug absorption.
- people have a history of severe cardiovascular or cerebrovascular disease within 6 months before the first use of the investigational drug.
- people have a hypertension medial history that blood is not well controlled despite treatment with multiple antihypertension drugs.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, 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 all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, 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.