Breast CancerPhase 2NCT04836520
SHR6390 Combined With Anastrozole for Preoperative Treatment of Breast Cancer.
A Phase 2 study testing SHR6390+anatrozole in people with 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 effect of SHR6390 combined with anastrozole on proliferation of HR-positive HER2-negative breast cancer tumor cells before surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SHR6390+anatrozole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2021to 31 Mar 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
- 1.Female subjects aged 18 to 75 years old, meet any of the following:
- Both ovaries have been removed, or the age is ≥60 years old;
- Age <60 years, natural post-menopausal state (defined as spontaneous menstrual cessation for at least 12 consecutive months without other pathological or physiological reasons), E2 and FSH are at postmenopausal levels;
- Premenopausal or perimenopausal female subjects must be willing to receive LHRH agonist treatment during the study; 2.T2-T4cN0M0 invasive breast cancer (according to the AJCC 8th edition breast cancer clinical staging guidelines), the tumor must be surgically resectable, the measurable lesion conforms to the RECIST 1.1 standard, and the maximum diameter of the primary tumor has been evaluated by clinical or imaging evaluation ≥ 2cm; 3.Willing to accept biopsy; 4.Luminal A confirmed by immunohistochemistry, ER≥50% and PR≥50%; 5.HER2 negative, defined as immunohistochemical test 0/1+; or FISH test HER2/CEP17 ratio is less than 2.0 or HER2 gene copy number is less than 4; 6.Patients are suitable for neoadjuvant therapy and willing to accept (judged by the investigator); 7.ECOG performance status score 0 or 1; 8.The expected survival period is not less than 12 weeks; 9.Adequate function of major organs； 10.Voluntary participation in the study, signed informed consent, good compliance and willingness to cooperate with follow-up.
Who cannot join
- Metastases confirmed by imaging or pathology, not including lymph node metastases in the ipsilateral and/or contralateral thoracic region or mediastinum;
- Inflammatory breast cancer, bilateral breast cancer or DCIS, invasive breast cancer with multiple focal lesions;
- Previous pathological diagnosis of HER2-positive breast cancer;
- Suffering from gastrointestinal diseases such as intestinal obstruction, peptic ulcer or active bleeding, which affects the taking and absorption of drugs;
- Previously treated with radiotherapy, chemotherapy, surgery (not including percutaneous puncture) or molecular targeted treatment;
- Previously received any CDK4/6 inhibitor drug treatment;
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- Participation in any other clinical trials within 4 weeks of enrollment；
- Concurrent use of any other Anti-cancer drugs；
- Other malignancies within 5 years, except cured in-situ of uterine cervix carcinoma , skin basal cell carcinoma and squamous-cell carcinoma;
- History of heart disease: (1) Arrhythmias requiring medical treatment or clinical significance, (2) Myocardial infarction, (3) Heart failure, (4)Any heart diseases that investigator believes not suitable for this study;
- History of allergy or hypersensitivity to any of the study drugs or study drug components; history of immunodeficiency including HIV-positive, active hepatitis B/C, other acquired, congenital immunodeficiency disease or history of organ transplantation；
- A clear history of neurological or mental disorders, including epilepsy or dementia；
- 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；
- According to the investigator's judgment, there is a concomitant disease that seriously endangers the safety of subjects or affects the completion of the study (including but not limited to severe hypertension, severe diabetes, active infection, thyroid disease that cannot be controlled by drugs)；
- 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
TianJin Medical University Cancer Institute and Hospital
Tianjin, 300060
About this study
Official title: Single-arm, Single-center, PhaseⅡ Clinical Study of SHR6390 Combined With Anastrozole for Preoperative Treatment of Hormone Receptor Positive and HER2 Negative Early or Locally Advanced Breast Cancer.
The study is being conducted to assess effect of SHR6390 combined with anastrozole on proliferation of HR-positive HER2-negative breast cancer tumor cells before surgery.
Read the detailed description
This is a single-arm, single-center, open-label Phase II clinical study. The purpose of this study was to evaluate the effect of SHR6390 combined with anastrozole on the proliferative activity of HR-positive HER2-negative breast cancer tumor cells before surgery.
- Conditions
- Breast Cancer
- Being tested
- SHR6390+anatrozole
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR6390+anatrozoleDrug
SHR6390 is a novel small molecule inhibitor specifically targeting the CDK4/6 pathway.
| Study group | Role | What they receive |
|---|---|---|
| SHR6390+anatrozole | Experimental | Hormone receptor positive, HER2 negative participants will receive SHR6390 in combination with anatrozole before surgery. Receives: Drug: SHR6390+anatrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Ki67 scores
Serial measures of Ki67 (%)
Measured: up to 5 months
RCB (0-1) after surgery
Rate of Residual Cancer Burden 0-1
Measured: 5 months
Secondary outcomes (3)
Objective response rate (ORR) evaluated by the investigator
ORR is defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) according to RECIST 1.1.
Measured: 16 weeks
tpCR
pCR is defined as the absence of noninvasive tumor residuals in breast and axillary lymph nodes (ypT0/is ypN0) after neoadjuvant therapy.
Measured: 5 months
Safety will be assessed using NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start2 Aug 2021
- Primary completion28 Feb 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 20 participants (actual)
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
- NCT04836520
- Sponsor's protocol ID
- BC-NEO-IIT-SHR6390
- Status last verified
- Apr 2022
- First submitted
- 2 Apr 2021
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm, Single-center, PhaseⅡ Clinical Study of SHR6390 Combined With Anastrozole for Preoperative Treatment of Hormone Receptor Positive and HER2 Negative Early or Locally Advanced Breast Cancer.
- ClinicalTrials.gov ID
- NCT04836520
- Acronym / sponsor ID
- BC-NEO-IIT-SHR6390
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 8 Apr 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 effect of SHR6390 combined with anastrozole on proliferation of HR-positive HER2-negative breast cancer tumor cells before surgery.
Detailed description
This is a single-arm, single-center, open-label Phase II clinical study. The purpose of this study was to evaluate the effect of SHR6390 combined with anastrozole on the proliferative activity of HR-positive HER2-negative breast cancer tumor cells before surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR6390+anatrozole | Experimental | Drug: SHR6390+anatrozoleHormone receptor positive, HER2 negative participants will receive SHR6390 in combination with anatrozole before surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both ovaries have been removed, or the age is ≥60 years old;
- Age <60 years, natural post-menopausal state (defined as spontaneous menstrual cessation for at least 12 consecutive months without other pathological or physiological reasons), E2 and FSH are at postmenopausal levels;
- Premenopausal or perimenopausal female subjects must be willing to receive LHRH agonist treatment during the study; 2.T2-T4cN0M0 invasive breast cancer (according to the AJCC 8th edition breast cancer clinical staging guidelines), the tumor must be surgically resectable, the measurable lesion conforms to the RECIST 1.1 standard, and the maximum diameter of the primary tumor has been evaluated by clinical or imaging evaluation ≥ 2cm; 3.Willing to accept biopsy; 4.Luminal A confirmed by immunohistochemistry, ER≥50% and PR≥50%; 5.HER2 negative, defined as immunohistochemical test 0/1+; or FISH test HER2/CEP17 ratio is less than 2.0 or HER2 gene copy number is less than 4; 6.Patients are suitable for neoadjuvant therapy and willing to accept (judged by the investigator); 7.ECOG performance status score 0 or 1; 8.The expected survival period is not less than 12 weeks; 9.Adequate function of major organs； 10.Voluntary participation in the study, signed informed consent, good compliance and willingness to cooperate with follow-up.
Key exclusion criteria (15 listed)
- Metastases confirmed by imaging or pathology, not including lymph node metastases in the ipsilateral and/or contralateral thoracic region or mediastinum;
- Inflammatory breast cancer, bilateral breast cancer or DCIS, invasive breast cancer with multiple focal lesions;
- Previous pathological diagnosis of HER2-positive breast cancer;
- Suffering from gastrointestinal diseases such as intestinal obstruction, peptic ulcer or active bleeding, which affects the taking and absorption of drugs;
- Previously treated with radiotherapy, chemotherapy, surgery (not including percutaneous puncture) or molecular targeted treatment;
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+anatrozoleSHR6390 is a novel small molecule inhibitor specifically targeting the CDK4/6 pathway. | Drug | SHR6390+anatrozole |
Primary outcome
Changes in Ki67 scores
Time frame: up to 5 months
Serial measures of Ki67 (%)
RCB (0-1) after surgery
Time frame: 5 months
Rate of Residual Cancer Burden 0-1
3 secondary outcomes
Objective response rate (ORR) evaluated by the investigator
Time frame: 16 weeks
tpCR
Time frame: 5 months
Safety will be assessed using NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
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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+anatrozole in people with 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 4 inclusion and 15 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: finished, as of the sponsor's last update on 12 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in Ki67 scores (time frame: up to 5 months). 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 12 Apr 2023.