A Phase Ib/II Study of QLC1401 Combined With CDK4/6 or mTOR Inhibitors in ER+/HER2- Advanced Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QLC1401, QLC1401.
- Who it may be relevant to
- Registry conditions: Advanced Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of Safety, Tolerability, Efficacy, and Pharmacokinetic Characteristics of QLC1401 Tablets Combined With CDK4/6 Inhibitors or mTOR Inhibitors in Patients With Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Locally Advanced or Metastatic Breast Cancer: A Phase Ib/II Clinical Study
Overview
This study is an open-label, multicenter, Phase Ib/II clinical trial designed to evaluate the safety, tolerability, efficacy, and pharmacokinetic characteristics of QLC1401 tablets in combination with CDK4/6 inhibitors or mTOR inhibitors in patients with ER+/HER2- locally advanced or metastatic breast cancer. The study consists of two stages: a Phase Ib dose-escalation stage and a Phase II dose-expansion stage.
Interventions
- Drug QLC1401
CDK4/6 inhibitors: Palbociclib, Abemaciclib, Ribociclib - Drug QLC1401
mTOR inhibitors: Everolimus
Primary outcome measures
- Safety and Tolerability (Phase Ib) [Time frame: Throughout phase Ib (approximately 1 year)]
- Recommended phase II dose (RP2D) (Phase Ib) [Time frame: Throughout phase Ib (approximately 1 year)]
- Objective Response Rate (ORR) (Phase II) [Time frame: From time of Informed Consent to confirmed progressive disease (approximately 1 year)]
Eligibility criteria
Inclusion criteria
- Voluntarily participate in the clinical trial, understand and sign the informed consent form, and agree to comply with the requirements specified in the protocol.
- Age ≥ 18 years.
- Female subjects must be postmenopausal and meet the trial requirements.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- Life expectancy ≥ 3 months.
- Histologically or cytologically confirmed breast cancer.
- Based on the most recent biopsy results of primary or metastatic tumor tissue, immunohistochemistry (IHC) confirms ER-positive status and HER-2-negative status.
- At least one measurable target lesion according to RECIST v1.1.
- Adequate bone marrow function within 2 weeks (14 days) prior to the initiation of study treatment, without the need for transfusion or growth factor (G-CSF, EPO, TPO, etc.) support.
- Adequate liver function.
- Renal function: serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (Ccr) > 30 mL/min, with no significant electrolyte imbalances that are difficult to correct.
- Coagulation function: International Normalized Ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
Exclusion criteria
- Presence of symptomatic visceral disease or any other condition deemed unsuitable for endocrine therapy as per the investigator's judgment.
- Presence of unresolved toxicities from prior therapy that have not recovered to ≤ CTCAE grade 1, excluding alopecia (any grade) or other toxicities considered by the investigator to pose no safety risk.
- Received anti-tumor drug therapy within the specified time window prior to the first dose of the investigational drug.
- Prior treatment with an experimental SERD or experimental ER antagonist.
- Received radiotherapy within 4 weeks prior to the first dose of the investigational drug.
- Used a strong CYP3A4 inhibitor within 7 days or 5 half-lives (whichever is longer) prior to the first dose.
- Underwent major surgery within 4 weeks prior to the first dose of the investigational drug, or has not recovered from significant side effects, or has significant traumatic injury, non-healing wounds, or fractures.
- History of other active malignancies within 5 years prior to the first dose of the investigational drug.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Inability to swallow the formulation, or gastrointestinal impairment/disease that may affect adequate absorption of the investigational drug.
- Known clinically significant liver disease, including Child-Pugh class B or C, active viral hepatitis, or other hepatitis.
- Current documented grade 1 or higher pneumonitis or interstitial lung disease.
- Clinically significant pleural effusion, ascites, or pericardial effusion, defined as detectable on examination and requiring drainage within the past 2 weeks or additional medication to control symptoms.
- Clinically significant uncontrolled cardiac disease and/or recent cardiac events.
- History of bleeding tendency, thrombosis, or tumor embolism.
- Planned treatment with everolimus and presence of uncontrolled diabetes despite adequate therapy.
- Allergy to any of the investigational medicinal products or their components.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07173556 · QLC1401-201