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

NCT03927456 | Unknown Phase 3

• 1 other identifier: SHR6390-III-301
• Study Type: interventional
• Target: 357
• 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 Fulvestrant versus placebo combined with Fulvesrant in Patients who have HR positive and HER2 negative recurrent/metastatic breast cancer and have received prior endocrine therapy are eligible for study.

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Investigator-assessed PFS

  Investigator-assessed Progression Free Survival

  Up to approximately 24 months.

Secondary Outcomes (7)

• Progression-free Survival (PFS) per RECIST 1.1

  Up to approximately 24 months.

• OS

  Up to approximately 2 years

• ORR

  Up to approximately 24 months.

• DoR

  Up to approximately 24 months

• CBR

  Up to approximately 24 months.

Study Arms (2)

SHR6390 + Fulvestrant

EXPERIMENTAL

Intervention Drug: SHR6390, Fulvestrant

Drug: SHR6390; Drug: Fulvestrant

Placebo + Fulvestrant

PLACEBO COMPARATOR

Intervention Drug: Placebo, Fulvestrant

Drug: Placebo; Drug: Fulvestrant

Interventions

SHR6390 DRUG

SHR6390 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment

SHR6390 + Fulvestrant

Placebo DRUG

Placebo 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment

Placebo + Fulvestrant

Fulvestrant DRUG

Fulvestrant 500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 for every cycle until progressive disease

Placebo + Fulvestrant; SHR6390 + Fulvestrant

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, postmenopausal women or prepostmenopausal women
• Received prior endocrine therapy
• One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy.
• Eastern Cooperative Oncology Group \[ECOG\] 0-1

You may not qualify if:

• Patients who received prior treatment with any CDK4/6 inhibitor, everolimus or fulvestant.
• 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)

Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

Location

Related Publications (2)

• Liu YP, Hu MH, Lin PP, Li T, Liu SQ, Wang YY, Li SR, Li XK, Wang CJ, Cao Y. Evaluation of the Effect of Food on the Pharmacokinetics of SHR6390, An Oral CDK4/6 Inhibitor, in Healthy Volunteers. Drugs R D. 2022 Jun;22(2):175-182. doi: 10.1007/s40268-022-00390-7. Epub 2022 May 30.

  PMID: 35635717 DERIVED

• Xu B, Zhang Q, Zhang P, Hu X, Li W, Tong Z, Sun T, Teng Y, Wu X, Ouyang Q, Yan X, Cheng J, Liu Q, Feng J, Wang X, Yin Y, Shi Y, Pan Y, Wang Y, Xie W, Yan M, Liu Y, Yan P, Wu F, Zhu X, Zou J; DAWNA-1 Study Consortium. Dalpiciclib or placebo plus fulvestrant in hormone receptor-positive and HER2-negative advanced breast cancer: a randomized, phase 3 trial. Nat Med. 2021 Nov;27(11):1904-1909. doi: 10.1038/s41591-021-01562-9. Epub 2021 Nov 4.

  PMID: 34737452 DERIVED

MeSH Terms

Interventions

Fulvestrant

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

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

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 25, 2019
• Study Start: June 13, 2019
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2022
• Last Updated: June 3, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)