A Study of SHR6390 in Combination With Letrozole or Anastrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer

NCT03966898 | Unknown Phase 3

• 1 other identifier: SHR6390-III-302
• Study Type: interventional
• Target: 426
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase III clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Letrozole or Anastrozole versus placebo in combination with Letrozole or Anastrozole in Patients who have HR positive and HER2 negative recurrent/metastatic breast cancer and have not received systemic anticancer therapy are eligible for this study.

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Investigator-assessed PFS

  Investigator-assessed Progression Free Survival

  Every 8 weeks from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, Up to approximately 24 months.

Secondary Outcomes (6)

• Progression-free Survival (PFS) per RECIST 1.1

  Up to approximately 24 months

• OS

  up to 2 years

• ORR

  Up to approximately 24 months

• DoR

  Up to approximately 24 months

• CBR

  Up to approximately 24 months

Other Outcomes (1)

• Ctrough

  Up to 4 weeks

Study Arms (2)

SHR6390, Letrozole or Anastrozole

EXPERIMENTAL

SHR6390, Letrozole or Anastrozole

Drug: SHR6390 Tablets; Drug: Letrozole or Anastrozole Tablets

Placebo, Letrozole or Anastrozole

PLACEBO COMPARATOR

Placebo, Letrozole or Anastrozole

Drug: Placebo Tablets; Drug: Letrozole or Anastrozole Tablets

Interventions

SHR6390 Tablets DRUG

SHR6390 Tablets

SHR6390, Letrozole or Anastrozole

Placebo Tablets DRUG

Placebo Tablets

Placebo, Letrozole or Anastrozole

Letrozole or Anastrozole Tablets DRUG

Letrozole or Anastrozole Tablets

Placebo, Letrozole or Anastrozole; SHR6390, Letrozole or Anastrozole

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer.
• Age: 18 - 75 years old
• No prior systemic anti-cancer therapy for advanced HR+ disease.
• Eastern Cooperative Oncology Group \[ECOG\] 0-1

You may not qualify if:

• Patients who received prior treatment with any CDK4/6 inhibitor.
• Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class \> 2), or ventricular arrhythmia which need medical intervention.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Nayima Bayaxi

Shanghai, China

Location

Related Publications (2)

• Hong J, Chen T, Ouyang L, Du N, Li A, Zhou Z, Zhang H, Xia Z, Meng J. Cost-effectiveness comparison of dalpiciclib and abemaciclib combined with an aromatase inhibitor as first-line treatment for HR+/HER2- advanced breast cancer. Expert Rev Pharmacoecon Outcomes Res. 2024 Apr;24(4):559-566. doi: 10.1080/14737167.2024.2330542. Epub 2024 Mar 20.

  PMID: 38470447 DERIVED

• Zhang P, Zhang Q, Tong Z, Sun T, Li W, Ouyang Q, Hu X, Cheng Y, Yan M, Pan Y, Teng Y, Yan X, Wang Y, Xie W, Zeng X, Wang X, Hu C, Geng C, Zhang H, Li W, Wu X, Zhong J, Xu J, Shi Y, Wei W, Bayaxi N, Zhu X, Xu B. Dalpiciclib plus letrozole or anastrozole versus placebo plus letrozole or anastrozole as first-line treatment in patients with hormone receptor-positive, HER2-negative advanced breast cancer (DAWNA-2): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2023 Jun;24(6):646-657. doi: 10.1016/S1470-2045(23)00172-9. Epub 2023 May 11.

  PMID: 37182538 DERIVED

MeSH Terms

Interventions

Letrozole; Anastrozole

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR6390 in combination with Letrozole or Anastrozole versus placebo in combination with Letrozole or Anastrozole

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 29, 2019
• Study Start: July 19, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2023
• Last Updated: June 2, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)