ER+ HER2- Advanced Breast CancerPhase 1NCT03596658
SHR9549 in ER Positive HER2 Negative Advanced Breast Cancer
A Phase 1 study testing SHR9549 in people with ER+ HER2- Advanced Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a phase 1 open label multicentre study of SHR9549 administered orally in patients with advanced estrogen receptor (ER) positive human epidermal receptor 2 (HER2) negative breast cancer. The study design allows an escalation of dose with intensive safety monitoring to ensure the safety of patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- ER+ HER2- Advanced Breast Cancer
- What is being tested?
- SHR9549
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteChina
- Study dates
- 25 Jul 2018to 14 Oct 2019
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-70 years.
- Confirmation of ER positive; HER2 negative Advanced breast cancer
- Documented disease progression after at least 6 months prior endocrine therapy for ER positive breast cancer.
- Receipt of ≤2 lines of prior chemotherapy for advanced disease.
- Any menopausal status.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 and with minimum life expectancy of 12 weeks.
Who cannot join
- Any anti-cancer drugs for the treatment of advanced breast cancer within 14 days of the first dose of study treatment.
- Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment with the exception of alopecia.
- Patient who is unsuitable for endocrine therapy alone including presence of life-threatening metastatic visceral disease.
- uncontrolled central nervous system metastatic disease.
- Any evidence of severe or uncontrolled systemic diseases.
- Inadequate bone marrow reserve or organ function.
Trial locations and contacts
1 site in 1 country.
China1 site
The 307th Hospital of Military Chinese People's Liberation Army
Beijing, Beijing Municipality, 100071
About this study
Official title: Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of SHR9549 in Women With ER Positive HER2 Negative Advanced Breast Cancer
This is a phase 1 open label multicentre study of SHR9549 administered orally in patients with advanced estrogen receptor (ER) positive human epidermal receptor 2 (HER2) negative breast cancer. The study design allows an escalation of dose with intensive safety monitoring to ensure the safety of patients. The study will determine the maximum tolerated dose(MTD). In addition, expansion cohort(s) at potential therapeutic dose(s) in patients will be enrolled to further determine the safety, tolerability, pharmacokinetics and biological activity of SHR9549.
Read the detailed description
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of SHR9549 in Women with Estrogen Receptor (ER) Positive Human Epidermal Receptor (HER-2) Negative Advanced Breast Cancer
- Conditions
- ER+ HER2- Advanced Breast Cancer
- Being tested
- SHR9549
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR9549Drug
Also called SHR9549 tablet
If initial dosing of SHR9549 is tolerated then subsequent cohorts will test increasing doses until a maximum tolerated dose(MTD) is defined
| Study group | Role | What they receive |
|---|---|---|
| SHR9549 dose escalation and expansion(s) | Experimental | Escalating dose of SHR9549 with intensive safety monitoring to ensure the safety of patients Receives: Drug: SHR9549 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limited Toxicity (DLT)
to determine DLT in order to assess the tolerability of SHR9549
Measured: baseline through 28 days
Maximum Tolerated Dose (MTD)
to determine MTD in order to assess the tolerability of SHR9549
Measured: baseline through 28 days
Secondary outcomes (5)
Peak Plasma Concentration (Cmax)
Single and multiple dose pharmacokinetic parameters of SHR9549 at pre-defined intervals
Measured: baseline through 12 weeks
Area under the plasma concentration versus time curve (AUC)
Single and multiple dose pharmacokinetic parameters of SHR9549 at pre-defined intervals
Measured: baseline through 12 weeks
overall response rate (ORR)
Antitumour activity by evaluation of tumour response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
Measured: every 8 weeks for 24 weeks and then every 12 weeks thereafter through study completion, an average of 6 months
progression free survival (PFS)
Antitumour activity evaluation by following up patients' progression and survival
Measured: every 8 weeks for 24 weeks and then every 12 weeks thereafter through study completion, an average of 6 months
Incidence of Treatment-Emergent Adverse Events
to assess the safety of SHR9549
Measured: baseline through 30 days after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start25 Jul 2018
- Primary completion14 Oct 2019
- Study completion14 Oct 2019
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
- 4 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
- NCT03596658
- Sponsor's protocol ID
- SHR9549-I-101
- Status last verified
- Jul 2018
- First submitted
- 25 Jun 2018
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of SHR9549 in Women With ER Positive HER2 Negative Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT03596658
- Acronym / sponsor ID
- SHR9549-I-101
- Conditions
- ER+ HER2- Advanced Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor R \& D Strategy Adjustment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 14 Oct 2019 (actual)
- Study completion
- 14 Oct 2019 (actual)
- First posted
- 24 Jul 2018 (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.
This is a phase 1 open label multicentre study of SHR9549 administered orally in patients with advanced estrogen receptor (ER) positive human epidermal receptor 2 (HER2) negative breast cancer. The study design allows an escalation of dose with intensive safety monitoring to ensure the safety of patients. The study will determine the maximum tolerated dose(MTD). In addition, expansion cohort(s) at potential therapeutic dose(s) in patients will be enrolled to further determine the safety, tolerability, pharmacokinetics and biological activity of SHR9549.
Detailed description
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of SHR9549 in Women with Estrogen Receptor (ER) Positive Human Epidermal Receptor (HER-2) Negative 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 |
|---|---|---|
| SHR9549 dose escalation and expansion(s) | Experimental | Drug: SHR9549Escalating dose of SHR9549 with intensive safety monitoring to ensure the safety of patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18-70 years.
- Confirmation of ER positive; HER2 negative Advanced breast cancer
- Documented disease progression after at least 6 months prior endocrine therapy for ER positive breast cancer.
- Receipt of ≤2 lines of prior chemotherapy for advanced disease.
- Any menopausal status.
Key exclusion criteria (6 listed)
- Any anti-cancer drugs for the treatment of advanced breast cancer within 14 days of the first dose of study treatment.
- Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment with the exception of alopecia.
- Patient who is unsuitable for endocrine therapy alone including presence of life-threatening metastatic visceral disease.
- uncontrolled central nervous system metastatic disease.
- Any evidence of severe or uncontrolled systemic diseases.
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 |
|---|---|---|
| SHR9549Also: SHR9549 tabletIf initial dosing of SHR9549 is tolerated then subsequent cohorts will test increasing doses until a maximum tolerated dose(MTD) is defined | Drug | SHR9549 dose escalation and expansion(s) |
Primary outcome
Dose Limited Toxicity (DLT)
Time frame: baseline through 28 days
to determine DLT in order to assess the tolerability of SHR9549
Maximum Tolerated Dose (MTD)
Time frame: baseline through 28 days
to determine MTD in order to assess the tolerability of SHR9549
5 secondary outcomes
Peak Plasma Concentration (Cmax)
Time frame: baseline through 12 weeks
Area under the plasma concentration versus time curve (AUC)
Time frame: baseline through 12 weeks
overall response rate (ORR)
Time frame: every 8 weeks for 24 weeks and then every 12 weeks thereafter through study completion, an average of 6 months
progression free survival (PFS)
Time frame: every 8 weeks for 24 weeks and then every 12 weeks thereafter through study completion, an average of 6 months
Incidence of Treatment-Emergent Adverse Events
Time frame: baseline through 30 days after study completion
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 1 Sep 2022.
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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 SHR9549 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 6 inclusion and 6 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 1 Sep 2022. 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?
Dose Limited Toxicity (DLT) (time frame: baseline through 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 1 Sep 2022.