Advanced Breast CancerPhase 2NCT04733417
A Study of SHR6390 Combined With Famitinib in the Treatment of HR + / HER2- Advanced Breast Cancer.
A Phase 2 study testing SHR6390 and famitinib in people with Advanced Breast Cancer and Metastatic Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
The study is being conducted to assess the efficacy and safety of SHR6390 combined with famitinib in the treatment of advanced or metastatic breast cancer that progress in 1-2 line endocrine therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Advanced Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- SHR6390 and famitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 26 May 2021to 30 Sep 2023
- Phase
- Phase 2
- 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 HR+/HER2- recurrent/metastatic breast cancer;
- Participants must not have received more than two prior lines of hormonal therapy;
- Participants must not have received more than two prior lines of chemotherapy in recurrence or metastatic setting. In addition, participants must have been treated with taxanes.
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- 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. Participants must have experienced disease recurrence or progression during or after last therapy;
- Adequate function of major organs
- Participants who have not received anticoagulation therapy: INR≤1.5, APTT≤1.5 ULN. Participants receiving full-dose or parenteral anticoagulation therapy had a stable dose of anticoagulant for more than 2 weeks before entering the clinical study, the result of the coagulation test is within the normal range;
- Women of childbearing potential who have a negative pregnancy test within 14 months before enrollment and willing to use adequate contraception prior to enrollment and for the duration of study participation;
- No radiotherapy, chemotherapy, molecular targeted therapy, immunotherapy, or surgery were received within 4 weeks before enrollment, and the toxicity of the previous treatment has been restored to ≤1 grade (such as surgery, the wound has healed completely); no endocrine therapy within 7 days before enrollment;
- Voluntary participation in the study, signed informed consent, good compliance and willingness to cooperate with follow-up.
Who cannot join
- Participants who previously received VEGFR TKI;
- Participants who previously received CDK4/6 inhibitor;
- Allergy to study drug or its components;
- Metastasis history of the central nervous system, or brain imaging at baseline or clinical evidence suggests the presence of CNS;
- Participated in other drug clinical trials within 4 weeks before the first dose;
- Other malignancies within 5 years, except cured in-situ of uterine cervix carcinoma , skin basal cell carcinoma and squamous-cell carcinoma
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- History of heart disease: uncontrollable hypertension (>140/90 mm Hg), hypertensive crisis or hypertensive encephalopathy, ≥ Grade II myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (≥Grade 2, QTc interval ≥470 ms), can't stop taking drugs that may prolong QT (such as antiarrhythmic drugs) during the study; Ⅲ ~ Ⅳ stage heart failure(according to NYHA), or LVEF <50%;
- Abnormal coagulation function (INR>1.5 or PT >ULN+4 seconds or APTT>1.5 ULN), have bleeding or thrombotic tendency or receiving thrombolytic or anticoagulant therapy;
- A history of bleeding, with clinically significant bleeding symptoms or clear bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ≥++, or vasculitis;
- Arterial/venous thrombosis occurred within one year before screening;
- Tumor has invaded important blood vessels or the tumor is likely to invade important blood vessels and cause fatal hemorrhage during treatment; thyroid function is abnormal, even treatment cannot maintain normal thyroid function;
- Urine routine test indicates urine protein ≥(++), or 24-hour urine protein ≥1.0g;
- Long-term unhealed wounds or fractures;
- Received major surgery or suffered severe traumatic injury, fracture or ulcer within 4 weeks after enrollment;
- Poor absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction;
- Active HBV/HCV/HIV infection;
- Pregnant or breastfeeding women. Women of childbearing potential who have a positive pregnancy test or unwilling to use adequate contraception prior to enrollment and for the duration of study participation； Any condition which in the investigator's opinion makes the subjects unsuitable for the study participation.
Trial locations and contacts
1 site in 1 country.
China1 site
Breast Oncology, Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
About this study
Official title: An Exploratory Study of CDK4/6 Inhibitor SHR6390 Combined With Famitinib in the Treatment of HR + / HER2- Advanced Breast Cancer.
The study is being conducted to assess the efficacy and safety of SHR6390 combined with famitinib in the treatment of advanced or metastatic breast cancer that progress in 1-2 line endocrine therapy.
Read the detailed description
This is a single-center, single-arm, open-label, Simon's two-stage design, phase II clinical trial. The purpose of this study was to evaluate the efficacy and safety of SHR6390 combined with famitinib in the treatment of HR+/HER2 advanced or metastatic breast cancer patients who have progressed during or after 1-2 line endocrine therapy. Subjects will be treated until disease progression, toxicity is intolerable, informed consent is withdrawn, and investigators determine that medication must be discontinued. Drug efficacy and safety data will be collected.
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer
- Being tested
- SHR6390, famitinib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR6390Drug
SHR6390 is a novel small molecule inhibitor specifically targeting the CDK4/6 pathway.
famitinibDrug
Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3.
| Study group | Role | What they receive |
|---|---|---|
| SHR6390+famitinib | Experimental | Participants will receive SHR6390 in combination with famitinib. Receives: Drug: SHR6390; Drug: famitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR is defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) according to RECIST 1.1.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months.
Secondary outcomes (5)
Clinical benefit rate (CBR)
Clinical benefit defined as Complete Response (CR), Partial Response (PR) or Stable Disease (SD) lasting >= 24 weeks, as determined by the Investigator according to RECIST v1.1.
Measured: Randomization in participants with measurable disease at baseline through the end of study (12 months after the last participant is enrolled).
Duration of Remission (DoR)
Defined as the time from the first CR or PR to the first assessment of PD or death, whichever comes first.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months.
Progression Free Survival (PFS)
Measured: Randomization to the first occurrence of disease progression as determined by the investigator according to (RECIST v1.1 ) or death from any cause, until the end of study (12 months after the last participant is enrolled)
Overall Survival (OS)
Measured: Randomization to the first occurrence of disease progression as determined by the investigator according to (RECIST v1.1 ) or death from any cause, until the end of study (12 months after the last participant is enrolled)
Safety Profile
Safety will be assessed using NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE) for reporting laboratory and non-laboratory toxicities.
Measured: From the first medication to 28 days after the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start26 May 2021
- Primary completion30 Aug 2022
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733417
- Sponsor's protocol ID
- BC-IIT-SHR6390-FMTN
- Status last verified
- Apr 2022
- First submitted
- 30 Dec 2020
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- 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 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of CDK4/6 Inhibitor SHR6390 Combined With Famitinib in the Treatment of HR + / HER2- Advanced Breast Cancer.
- ClinicalTrials.gov ID
- NCT04733417
- Acronym / sponsor ID
- BC-IIT-SHR6390-FMTN
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 26 May 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 2 Feb 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 efficacy and safety of SHR6390 combined with famitinib in the treatment of advanced or metastatic breast cancer that progress in 1-2 line endocrine therapy.
Detailed description
This is a single-center, single-arm, open-label, Simon's two-stage design, phase II clinical trial. The purpose of this study was to evaluate the efficacy and safety of SHR6390 combined with famitinib in the treatment of HR+/HER2 advanced or metastatic breast cancer patients who have progressed during or after 1-2 line endocrine therapy. Subjects will be treated until disease progression, toxicity is intolerable, informed consent is withdrawn, and investigators determine that medication must be discontinued. Drug efficacy and safety data will be collected.
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, Drug: 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 (12 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 HR+/HER2- recurrent/metastatic breast cancer;
- Participants must not have received more than two prior lines of hormonal therapy;
Key exclusion criteria (17 listed)
- Participants who previously received VEGFR TKI;
- Participants who previously received CDK4/6 inhibitor;
- Allergy to study drug or its components;
- Metastasis history of the central nervous system, or brain imaging at baseline or clinical evidence suggests the presence of CNS;
- Participated in other drug clinical trials within 4 weeks before the first dose;
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 |
|---|---|---|
| SHR6390SHR6390 is a novel small molecule inhibitor specifically targeting the CDK4/6 pathway. | Drug | SHR6390+famitinib |
| famitinibFamitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. | Drug | SHR6390+famitinib |
Primary outcome
Objective response rate (ORR)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months.
ORR is defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) according to RECIST 1.1.
5 secondary outcomes
Clinical benefit rate (CBR)
Time frame: Randomization in participants with measurable disease at baseline through the end of study (12 months after the last participant is enrolled).
Duration of Remission (DoR)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months.
Progression Free Survival (PFS)
Time frame: Randomization to the first occurrence of disease progression as determined by the investigator according to (RECIST v1.1 ) or death from any cause, until the end of study (12 months after the last participant is enrolled)
Overall Survival (OS)
Time frame: Randomization to the first occurrence of disease progression as determined by the investigator according to (RECIST v1.1 ) or death from any cause, until the end of study (12 months after the last participant is enrolled)
Safety Profile
Time frame: From the first medication to 28 days after the end of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 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 2 study testing SHR6390 and famitinib in people with Advanced Breast Cancer and Metastatic Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital 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 12 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 13 Apr 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Objective response rate (ORR) (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months.). 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 13 Apr 2023.