ER+ / HER2- Advanced Breast CancerPhase 1NCT05103826
A Study of SHR6390 Combined With Famitinib in the Treatment of ER + / HER2- Advanced Breast Cancer
A Phase 1 study testing SHR6390、Famitinib in people with ER+ / HER2- Advanced Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to assess the safety 、tolerability 、 pharmacokinetics and efficacy of SHR6390 combined with famitinib in the treatment of ER + / HER2- advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- ER+ / HER2- Advanced Breast Cancer
- What is being tested?
- SHR6390、Famitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2021to 15 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female subjects aged 18 to 75 years old；
- ECOG performance status 0-1;
- Life expectancy is not less than 12 weeks;
- Histological or cytological confirmation of ER+/HER2- recurrent/metastatic breast cancer;
- Participants with measurable disease must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST1.1;
- Adequate function of major organs;
- Voluntary participation in the study, signed informed consent, good compliance and willingness to cooperate with follow-up.
Who cannot join
- Confirmed diagnosis of HER2 positive disease;
- Participants who previously received SHR6390 or VEGFR inhibitors;
- Allergy to study drug or its components;
- Participated in other drug clinical trials within 4 weeks before the first dose;
- Other malignancies within 3 years, except cured non-melanoma skin cancer , skin basal cell carcinoma and squamous-cell carcinoma or carcinoma in situ of the cervix;
- 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；
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- Tumor has invaded important blood vessels or the tumor is likely to invade important blood vessels and cause fatal hemorrhage during treatment;
- Urine routine test indicates urine protein ≥(++), or 24-hour urine protein >1.0g;
- Active HBV/HCV/HIV infection;
- The investigators determined that other conditions were inappropriate for participation in this clinical trial；
- Pregnant or breast-feeding women;
- Central nervous system (CNS) invasion.
Trial locations and contacts
1 site in 1 country.
China1 site
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
About this study
Official title: A Phase I Study to Evaluate Safety 、Tolerability 、 Pharmacokinetics and Efficacy of SHR6390 in Combination With Famitinib in the Treatment of ER + / HER2- Advanced Breast Cancer
The study is being conducted to assess the safety 、tolerability 、 pharmacokinetics and efficacy of SHR6390 combined with famitinib in the treatment of ER + / HER2- advanced breast cancer.
- Conditions
- ER+ / HER2- Advanced Breast Cancer
- Being tested
- SHR6390、Famitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR6390、FamitinibDrug
SHR6390, oral;Famitinib, oral.
| Study group | Role | What they receive |
|---|---|---|
| SHR6390+famitinib | Experimental | Participants will receive SHR6390 in combination with famitinib. Receives: Drug: SHR6390、Famitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Safety Lead-in) dose limited toxicity (DLT) of SHR6390+famitinib in the first cycle
Measured: up to 28 days
(Safety Lead-in) Recommended Phase II Dose (RP2D) of SHR6390+famitinib
Measured: up to 28 days
Secondary outcomes (11)
AEs+SAEs
from the first drug administration to within 30 days for the last treatment dose
Measured: up to 24 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Cmax
Measured: 6 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Tmax
Measured: 6 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: t1/2
Measured: 6 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: AUC
Measured: 6 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: CL/F
Measured: 6 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Vz/F
Measured: 6 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Rac
Measured: 6 months
Objective Response Rate (ORR)
Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by CT or MRI
Measured: up to 24 months
Disease control rate (DCR)
Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1
Measured: up to 24 months
Duration of response (DoR)
Time from documentation of tumor response to disease progression assessed among patients who had an objective response
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start25 Oct 2021
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Why it stopped: Sponsor R \& D Strategy Adjustment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ER+ / HER2- Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103826
- Sponsor's protocol ID
- SHR6390-SHR1020-I-101-BC
- Status last verified
- Aug 2023
- First submitted
- 21 Oct 2021
- Last updated
- 15 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate Safety 、Tolerability 、 Pharmacokinetics and Efficacy of SHR6390 in Combination With Famitinib in the Treatment of ER + / HER2- Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT05103826
- Acronym / sponsor ID
- SHR6390-SHR1020-I-101-BC
- Conditions
- ER+ / HER2- Advanced Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor R \& D Strategy Adjustment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being conducted to assess the safety 、tolerability 、 pharmacokinetics and efficacy of SHR6390 combined with famitinib in the treatment of ER + / HER2- advanced breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR6390+famitinib | Experimental | Drug: SHR6390、FamitinibParticipants will receive SHR6390 in combination with famitinib. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female subjects aged 18 to 75 years old；
- ECOG performance status 0-1;
- Life expectancy is not less than 12 weeks;
- Histological or cytological confirmation of ER+/HER2- recurrent/metastatic breast cancer;
- Participants with measurable disease must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST1.1;
Key exclusion criteria (12 listed)
- Confirmed diagnosis of HER2 positive disease;
- Participants who previously received SHR6390 or VEGFR inhibitors;
- Allergy to study drug or its components;
- Participated in other drug clinical trials within 4 weeks before the first dose;
- Other malignancies within 3 years, except cured non-melanoma skin cancer , skin basal cell carcinoma and squamous-cell carcinoma or carcinoma in situ of the cervix;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR6390、FamitinibSHR6390, oral;Famitinib, oral. | Drug | SHR6390+famitinib |
Primary outcome
(Safety Lead-in) dose limited toxicity (DLT) of SHR6390+famitinib in the first cycle
Time frame: up to 28 days
(Safety Lead-in) Recommended Phase II Dose (RP2D) of SHR6390+famitinib
Time frame: up to 28 days
11 secondary outcomes
AEs+SAEs
Time frame: up to 24 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Cmax
Time frame: 6 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Tmax
Time frame: 6 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: t1/2
Time frame: 6 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: AUC
Time frame: 6 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: CL/F
Time frame: 6 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Vz/F
Time frame: 6 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Rac
Time frame: 6 months
Objective Response Rate (ORR)
Time frame: up to 24 months
Disease control rate (DCR)
Time frame: up to 24 months
Duration of response (DoR)
Time frame: up to 24 months
Results and safety
The study was stopped early (reason given: Sponsor R \& D Strategy Adjustment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR6390、Famitinib in people with ER+ / HER2- Advanced Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor R \& D Strategy Adjustment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Safety Lead-in) dose limited toxicity (DLT) of SHR6390+famitinib in the first cycle (time frame: up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.