About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.

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

Clinicaltrials.gov identifier NCT03927456

Recruitment Status Not yet recruiting

First Posted April 25, 2019

Last update posted April 25, 2019

Study Description

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.

  • Condition or Disease:Advanced Breast Cancer
  • Intervention/Treatment: Drug: SHR6390
    Drug: Placebo
    Drug: Fulvestrant
  • Phase: Phase 3
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 288 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Phase III Study to Evaluate the Efficacy and Safety of SHR6390 in Combination With Fulvestrant Versus Placebo Combined With Fulvesrant in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer
  • Estimated Study Start Date: May 2019
  • Estimated Primary Completion Date: June 2020
  • Estimated Study Completion Date: April 2021
Arms and interventions
Arm Intervention/treatment
Experimental: SHR6390 + Fulvestrant
Intervention Drug: SHR6390, Fulvestrant
Drug: SHR6390
SHR6390 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment

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

Drug: Fulvestrant
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
Outcome Measures
  • Primary Outcome Measures: 1. Investigator-assessed PFS [ Time Frame: Up to approximately 24 months. ]
    Investigator-assessed Progression Free Survival
  • Secondary Outcome Measures: 1. DoR [ Time Frame: Up to approximately 24 months ]
    Duration of Objective Response
  • 2. CBR [ Time Frame: Up to approximately 24 months. ]
    Clinical Benefit rate
  • 3. OS [ Time Frame: Up to approximately 2 years ]
    Overall Survival
  • 4. ORR [ Time Frame: Up to approximately 24 months. ]
    Objective Response Rate
  • 5. Progression-free Survival (PFS) per RECIST 1.1 [ Time Frame: Up to approximately 24 months. ]
    PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurs first.
  • 6. AEs and SAEs [ Time Frame: Up to approximately 24 months. ]
    Number of Participants With adverse events (AEs) and serious adverse events (SAEs) Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.
  • 7. Ctrough [ Time Frame: Up to 4 weeks ]
    Ctrough
Eligibility Criteria
  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

1. Has the pathologically-confirmed diagnosis of locally recurrent or metastatic,
hormone-receptor positive, HER2 negative Breast Cancer.

2. Age: 18 - 75 years old, postmenopausal women or prepostmenopausal women

3. Received prior endocrine therapy

4. One previous line of chemotherapy for advanced/metastatic disease is allowed in
addition to endocrine therapy.

5. Eastern Cooperative Oncology Group [ECOG] 0-1

Exclusion Criteria:

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

2. 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.

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

Jiangsu HengRui Medicine Co., Ltd.

More Information
  • Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
  • ClinicalTrials.gov Identifier: NCT03927456 History of Changes
  • Other Study ID Numbers: SHR6390-III-301
  • First Posted: April 25, 2019 Key Record Dates
  • Last Update Posted: April 25, 2019
  • Last Verified: April 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Breast Neoplasms