A Study of SHR6390 in Combination With Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
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ClinicalTrials.gov Identifier: NCT03927456 |
Recruitment Status :
Not yet recruiting
First Posted : April 25, 2019
Last Update Posted : April 25, 2019
|
Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.
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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 | Intervention/treatment | Phase |
---|---|---|
Advanced Breast Cancer | Drug: SHR6390 Drug: Placebo Drug: Fulvestrant | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
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 15, 2019 |
Estimated Primary Completion Date : | June 1, 2020 |
Estimated Study Completion Date : | April 1, 2021 |
Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics:
Breast cancer
MedlinePlus related topics:
Breast Cancer
Drug Information available for:
Fulvestrant
Arm | Intervention/treatment |
---|---|
Experimental: SHR6390 + Fulvestrant
Intervention Drug: SHR6390, Fulvestrant
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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 |
Primary Outcome Measures :
- Investigator-assessed PFS [ Time Frame: Up to approximately 24 months. ]Investigator-assessed Progression Free Survival
Secondary Outcome Measures :
- 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.
- OS [ Time Frame: Up to approximately 2 years ]Overall Survival
- ORR [ Time Frame: Up to approximately 24 months. ]Objective Response Rate
- DoR [ Time Frame: Up to approximately 24 months ]Duration of Objective Response
- CBR [ Time Frame: Up to approximately 24 months. ]Clinical Benefit rate
- 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.
- Ctrough [ Time Frame: Up to 4 weeks ]Ctrough
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
No Contacts or Locations Provided
Responsible Party: | Jiangsu HengRui Medicine Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT03927456 |
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 Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Fulvestrant Antineoplastic Agents, Hormonal |
Antineoplastic Agents Estrogen Receptor Antagonists Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |