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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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

Other trials in China

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.

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 groups in NCT05103826
Study groupRoleWhat they receive
SHR6390+famitinibExperimentalParticipants 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.

  1. (Safety Lead-in) dose limited toxicity (DLT) of SHR6390+famitinib in the first cycle

    Measured: up to 28 days

  2. (Safety Lead-in) Recommended Phase II Dose (RP2D) of SHR6390+famitinib

    Measured: up to 28 days

Secondary outcomes (11)

  1. AEs+SAEs

    from the first drug administration to within 30 days for the last treatment dose

    Measured: up to 24 months

  2. Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Cmax

    Measured: 6 months

  3. Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Tmax

    Measured: 6 months

  4. Evaluation of pharmacokinetic parameter of SHR6390+famitinib: t1/2

    Measured: 6 months

  5. Evaluation of pharmacokinetic parameter of SHR6390+famitinib: AUC

    Measured: 6 months

  6. Evaluation of pharmacokinetic parameter of SHR6390+famitinib: CL/F

    Measured: 6 months

  7. Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Vz/F

    Measured: 6 months

  8. Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Rac

    Measured: 6 months

  9. 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

  10. Disease control rate (DCR)

    Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1

    Measured: up to 24 months

  11. 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.

  1. First posted2 Nov 2021
  2. Study start25 Oct 2021
  3. Primary completion15 Jun 2023
  4. Study completion15 Jun 2023

Why it stopped: Sponsor R \& D Strategy Adjustment

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT05103826.

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.

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