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Compares treatment options for Locally Advanced or Metastatic Breast Cancer
Official title Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer
ClinicalTrials.gov ID: NCT05744687
What this study is testing
What is SPH4336 Tablets 400mg?
SPH4336 Tablets 400mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for locally advanced or metastatic 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 designed to evaluate the safety and efficacy of SPH4336 combined with letrozole in first-line treatment of locally advanced or metastatic breast cancer
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
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
- Patients who voluntarily participate in the study, completely understand the study, and voluntarily sign the informed consent form (ICF).
- Female, ≥ 18 and ≤ 75 years of age at the time of signing the ICF.
- ECOG（Eastern Cooperative Oncology Group） performance status 0 or 1.
- Life expectancy ≥ 3 months.
- Patients with locally advanced or metastatic breast cancer who are unable to receive radical surgeries/other local therapies, with hormone receptor...
You likely can't join if
- Prior treatment with any CDK4/6 （Cyclin dependent kinase）inhibitor.
- Inflammatory breast cancer.
- Patients unsuitable for endocrine therapy at the investigator's discretion.
- History of other malignancies within 5 years prior to the start of study treatment.
- Patients with known central nervous system metastases.
- Taking anti-tumor traditional Chinese medicines at the time of signing the ICF.
See the full eligibility criteria
- Patients who voluntarily participate in the study, completely understand the study, and voluntarily sign the informed consent form (ICF).
- Female, ≥ 18 and ≤ 75 years of age at the time of signing the ICF.
- ECOG（Eastern Cooperative Oncology Group） performance status 0 or 1.
- Life expectancy ≥ 3 months.
- Patients with locally advanced or metastatic breast cancer who are unable to receive radical surgeries/other local therapies, with hormone receptor positive and human epidermal growth factor receptor 2 negative...
- No previous systemetic therapy for locally advanced or metastatic diseases that cannot receive radical surgeries/other local therapies.
- At least one measurable lesion as per the Response Evaluation Criteria in Solid Tumors.
- Postmenopausal or premenopausal/perimenopausal female patients. Premenopausal or perimenopausal women should consent to receive goserelin therapy during the study.
- Laboratory test results before randomization meet the relevant requirements for organ function.
- Prior treatment with any CDK4/6 （Cyclin dependent kinase）inhibitor.
- Inflammatory breast cancer.
- Patients unsuitable for endocrine therapy at the investigator's discretion.
- History of other malignancies within 5 years prior to the start of study treatment.
- Patients with known central nervous system metastases.
- Taking anti-tumor traditional Chinese medicines at the time of signing the ICF.
- Having undergone a surgery within 28 days prior to the start of study treatment, and hasn't yet recovered from adverse reactions of the surgery.
- History of myocardial infarction, unstable angina pectoris, severe arrhythmia, and symptomatic congestive heart failure before the start of study treatment; NYHA( New York Heart Association) Class ≥II; QTcF≥ 470 ms...
- History of ischemic stroke or severe thromboembolic disease before the start of study treatment.
- Being receiving potent CYP3A4 inhibitors or inducers at the time of signing the ICF.
- Hepatitis B surface antigen positive and HBV(Hepatitis B Virus) DNA \> 2,000 IU/mL or 104 copies/mL; HCV(hepatitis C virus) antibody positive and HCV RNA positive; or known HIV infection.
- Patients who participated in a clinical trial and received other investigational drugs within 30 days before the start of study treatment.
- History of severe anaphylactic diseases, history of severe drug allergy, or known allergy to any ingredient of the investigational product.
- Presence of diseases or conditions that may impact drug administration or gastrointestinal absorption before the start of study treatment, in the opinion of the investigator, makes them an unsuitable candidate for the...
- Uncontrolled infections within 2 weeks before the start of study treatment, in the opinion of the investigator, makes them an unsuitable candidate for the study.
- Pregnant or lactating women.
- Known history of substance abuse, excessive drinking, or illegal drug addiction; history of confirmed neurological or mental disorders.
- Presence of other diseases judged by the investigator that the risks of receiving the study treatment outweigh its benefits, or any other reason for which patients are ineligible for the study as assessed by the...
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Guiyang, Guizhou, China
- Anyang, Henan, China
- Luoyang, Henan, China
- Pingxiang, Jiangxi, China
- Changchun, Jilin, China
- Yinchuan, Ningxia, China
- Beijing, 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 Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Guiyang, Guizhou, China; Anyang, Henan, China; Luoyang, Henan, China; Pingxiang, Jiangxi, China and 3 more location(s). 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.