Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer

June 19, 2023 updated by: Shanghai Pharmaceuticals Holding Co., Ltd

Randomized, Double-blind, Placebo-controlled, Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

374

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100142
        • Recruiting
        • Peking university cancer hospital
        • Contact:
      • Tianjin, China, 300181
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Affiliated Cancer Hospital, Sun Yat-sen University
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China, 550000
        • Recruiting
        • The Affiliated Cancer Hospital of Guizhou Medical University
        • Contact:
    • Henan
      • Anyang, Henan, China, 455001
        • Recruiting
        • Anyang Tumor Hospital
        • Contact:
      • Luoyang, Henan, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Recruiting
        • Renmin Hospital of Wuhan University Hubei General Hospital
        • Contact:
    • Jiangsu
      • Suzhou, Jiangsu, China, 215004
        • Recruiting
        • The Second Affiliated Hospital of Soochow University
        • Contact:
    • Jiangxi
      • Pingxiang, Jiangxi, China, 337099
        • Recruiting
        • Pingxiang People's Hospital
        • Contact:
          • An Xiao
          • Phone Number: 0086-0799-6882099
    • Jilin
      • Chang chun, Jilin, China, 130022
        • Recruiting
        • The Second Norman Bethune Hospital of Jilin Univer
        • Contact:
    • Ningxia
      • Yinchuan, Ningxia, China, 750003
        • Recruiting
        • General Hospital of Ningxia Medical University
        • Contact:
    • Shandong
      • Tai'an, Shandong, China, 271099
        • Recruiting
        • Tai'an Central Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients who voluntarily participate in the study, completely understand the study, and voluntarily sign the informed consent form (ICF).
  2. Female, ≥ 18 and ≤ 75 years of age at the time of signing the ICF.
  3. ECOG（Eastern Cooperative Oncology Group） performance status 0 or 1.
  4. Life expectancy ≥ 3 months.
  5. 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 confirmed by tumor histopathology and molecular pathology.
  6. No previous systemetic therapy for locally advanced or metastatic diseases that cannot receive radical surgeries/other local therapies.
  7. At least one measurable lesion as per the Response Evaluation Criteria in Solid Tumors.
  8. Postmenopausal or premenopausal/perimenopausal female patients. Premenopausal or perimenopausal women should consent to receive goserelin therapy during the study.
  9. Laboratory test results before randomization meet the relevant requirements for organ function.

Exclusion Criteria:

  1. Prior treatment with any CDK4/6 （Cyclin dependent kinase）inhibitor.
  2. Inflammatory breast cancer.
  3. Patients unsuitable for endocrine therapy at the investigator's discretion.
  4. History of other malignancies within 5 years prior to the start of study treatment.
  5. Patients with known central nervous system metastases.
  6. Taking anti-tumor traditional Chinese medicines at the time of signing the ICF.
  7. 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.
  8. 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; LVEF(Left Ventricular Ejection Fractions)≤ 50%.
  9. History of ischemic stroke or severe thromboembolic disease before the start of study treatment.
  10. Being receiving potent CYP3A4 inhibitors or inducers at the time of signing the ICF.
  11. 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.
  12. Patients who participated in a clinical trial and received other investigational drugs within 30 days before the start of study treatment.
  13. History of severe anaphylactic diseases, history of severe drug allergy, or known allergy to any ingredient of the investigational product.
  14. 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 study.
  15. 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.
  16. Pregnant or lactating women.
  17. Known history of substance abuse, excessive drinking, or illegal drug addiction; history of confirmed neurological or mental disorders.
  18. 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 investigator and the sponsor.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SPH4336 Tablets 400mg
SPH4336 Tablets； Letrozole tablets
Drug: SPH4336 Tablets 400mg

SPH4336 Tablets ：Orally, 400mg once a day; 28 days/cycle

Letrozole tablets ：Orally, 2.5mg once a day; 28 days/cycle
Placebo Comparator: SPH4336 Tablets Placebo
SPH4336 Placebo； Letrozole tablets
Drug: SPH4336 Tablets Placebo

SPH4336 Tablets Placebo：Orally,28 days/cycle

Letrozole tablets ：Orally, 2.5mg once a day; 28 days/cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
response rate (ORR)
Time Frame: Approximately 3years
tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Approximately 3years
Progression-free survival (PFS)
Time Frame: Approximately 3years
from the start date of study treatment to the date of progression disease or death , whichever occurred first.
Approximately 3years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: Approximately 3years
PK (Pharmacokinetics) parameters
Approximately 3years
Tmax
Time Frame: Approximately 3years
PK (Pharmacokinetics) parameters
Approximately 3years
Disease control rate (DCR)
Time Frame: Approximately 3years
DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease.
Approximately 3years
Duration of remission (DOR)
Time Frame: Approximately 3years
DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response to the date of disease progression per RECIST v1.1 or death from any cause.
Approximately 3years
Overall Survival (OS)
Time Frame: Approximately 8years
Determination of the overall survival times of all patients.
Approximately 8years
Incidence of Adverse event
Time Frame: Approximately 3years
Safety and tolerability
Approximately 3years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2023

Primary Completion (Estimated)

August 18, 2024

Study Completion (Estimated)

December 16, 2024

Study Registration Dates

First Submitted

February 16, 2023

First Submitted That Met QC Criteria

February 24, 2023

First Posted (Actual)

February 27, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 19, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPH4336-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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