Advanced HR+ HER2 Negative Breast CarcinomaNCT05295043
Advanced Breast Cancer Study of CDK4/6 Inhibitor Combined With Endocrine Therapy Endocrine Therapy in HR+/HER2- Advanced Breast Cancer
A study testing (CDK)4/6 inhibitor in people with Advanced HR+ HER2 Negative Breast Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
By retrospectively collecting and arranging real-world data of multi-center HR+/HER2- advanced breast cancer in China combined with CDK4/6 inhibitor and endocrine therapy, we analyzed different HER2 expression levels (HER2 0, 1+, 2+ and FISH-), especially Clinical outcomes of endocrine therapy for metastatic breast… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced HR+ HER2 Negative Breast Carcinoma
- What is being tested?
- (CDK)4/6 inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2022to 1 Jan 2024
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Female patients with advanced breast cancer aged ≥18 years. 2) For breast cancer patients diagnosed as HR-positive and HER2-negative by pathological examination, the expression levels of ER, PR, and HER2 were reported by immunohistochemistry in the primary or metastatic lesions.
- ER positivity and/or PR positivity is defined as: the proportion of tumor cells with positive staining accounts for ≥ 10% of all tumor cells (confirmed by the investigator of the trial center);
- HER2 negative is defined as: standard immunohistochemistry (IHC) test is 0/1+; HER2 (2+) needs to be tested by FISH, HER2/CEP17 ratio is less than 2.0 or HER2 gene copy number is less than 4 (by the test center of the test center) Investigator review and confirmation).
- 3) CDK4/6 inhibitors combined with endocrine therapy can conduct complete efficacy evaluation and follow-up information collection.
- 4) Postmenopausal or premenopausal/perimenopausal female patients can be enrolled.
- Postmenopausal status, defined as meeting at least one of the following criteria: prior bilateral ovarian surgery; age ≥60 years; age <60 years, menopause for at least 12 months (not due to chemotherapy, tamoxifen, toremide) fen or ovarian suppression) and follicle-stimulating hormone (FSH) and estrogen levels are in the postmenopausal range.
- Premenopausal or perimenopausal women may also be enrolled, but must be willing to receive LHRHa during the study period.
- 5) According to RECIST 1.1 criteria, patients must have: a) measurable lesions; b) unmeasurable osteolytic or mixed (osteolytic + osteoblastic) bone lesions in the absence of measurable lesions.
Who cannot join
- 1) Early breast cancer patients receive CDK4/6 inhibitor drug therapy. 2) HER2 overexpression or gene amplification, such as immunohistochemical score 3+ or positive fluorescence in situ hybridization.
- 3) Pregnant or lactating female patients. 4) Patients deemed unsuitable for inclusion by the investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter Clinical Study Evaluating Real-world CDK4/6 Inhibitor Combined With Endocrine Therapy in HR+/HER2- Advanced Breast Cancer
By retrospectively collecting and arranging real-world data of multi-center HR+/HER2- advanced breast cancer in China combined with CDK4/6 inhibitor and endocrine therapy, we analyzed different HER2 expression levels (HER2 0, 1+, 2+ and FISH-), especially Clinical outcomes of endocrine therapy for metastatic breast cancer with low HER2 expression (HER2 1+, 2+ and FISH-), exploring potential biomarkers of CDK4/6 inhibitors, and understanding the outcome characteristics of HER2 heterogeneity in MBC through multivariate analysis , and guide clinical application.
- Being tested
- (CDK)4/6 inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(CDK)4/6 inhibitorDrug
Also called ET
CDK4/6 inhibitor + AI/fulvestrant therapy，According to clinical guidelines or drug instructions, the treating physician will adjust the drug dose in accordance with the clinical reality and the patient's personal situation.
| Study group | Role | What they receive |
|---|---|---|
| HR+/HER2- advanced breast cancer patients receiving CDK4/6 inhibitor combined with endocrine therapy | Experimental | According to clinical guidelines or drug instructions, the treating physician will adjust the drug dose in accordance with the clinical reality and the patient's personal situation. Receives: Drug: (CDK)4/6 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) From enrollment to progression or death (for any reason) Progression-free survival (PFS)
From enrollment to progression or death (for any reason)
Measured: Estimated 24 months
Secondary outcomes (3)
Objective response rate (ORR)
Ratio of CR and PR in all subjects
Measured: Estimated 24 months
Disease Control Rate (DCR)
Ratio of CR ,PR and SD in all subjects
Measured: Estimated 24 months
Overall survival (OS)
From enrollment to death (for any reason)
Measured: Estimated 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start10 Dec 2022 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced HR+ HER2 Negative Breast CarcinomaStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295043
- Sponsor's protocol ID
- BC-RWS
- Status last verified
- Mar 2022
- First submitted
- 15 Mar 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study Evaluating Real-world CDK4/6 Inhibitor Combined With Endocrine Therapy in HR+/HER2- Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT05295043
- Acronym / sponsor ID
- BC-RWS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 10 Dec 2022 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 24 Mar 2022 (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.
By retrospectively collecting and arranging real-world data of multi-center HR+/HER2- advanced breast cancer in China combined with CDK4/6 inhibitor and endocrine therapy, we analyzed different HER2 expression levels (HER2 0, 1+, 2+ and FISH-), especially Clinical outcomes of endocrine therapy for metastatic breast cancer with low HER2 expression (HER2 1+, 2+ and FISH-), exploring potential biomarkers of CDK4/6 inhibitors, and understanding the outcome characteristics of HER2 heterogeneity in MBC through multivariate analysis , and guide clinical application.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HR+/HER2- advanced breast cancer patients receiving CDK4/6 inhibitor combined with endocrine therapy | Experimental | Drug: (CDK)4/6 inhibitorAccording to clinical guidelines or drug instructions, the treating physician will adjust the drug dose in accordance with the clinical reality and the patient's personal situation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1) Female patients with advanced breast cancer aged ≥18 years. 2) For breast cancer patients diagnosed as HR-positive and HER2-negative by pathological examination, the expression levels of ER, PR, and HER2 were reported by immunohistochemistry in the primary or metastatic lesions.
- 3) CDK4/6 inhibitors combined with endocrine therapy can conduct complete efficacy evaluation and follow-up information collection.
- 4) Postmenopausal or premenopausal/perimenopausal female patients can be enrolled.
- Postmenopausal status, defined as meeting at least one of the following criteria: prior bilateral ovarian surgery; age ≥60 years; age <60 years, menopause for at least 12 months (not due to chemotherapy, tamoxifen, toremide) fen or ovarian suppression) and follicle-stimulating hormone (FSH) and estrogen levels are in the postmenopausal range.
- Premenopausal or perimenopausal women may also be enrolled, but must be willing to receive LHRHa during the study period.
Key exclusion criteria (2 listed)
- 1) Early breast cancer patients receive CDK4/6 inhibitor drug therapy. 2) HER2 overexpression or gene amplification, such as immunohistochemical score 3+ or positive fluorescence in situ hybridization.
- 3) Pregnant or lactating female patients. 4) Patients deemed unsuitable for inclusion by the investigator.
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 |
|---|---|---|
| (CDK)4/6 inhibitorAlso: ETCDK4/6 inhibitor + AI/fulvestrant therapy，According to clinical guidelines or drug instructions, the treating physician will adjust the drug dose in accordance with the clinical reality and the patient's personal situation. | Drug | HR+/HER2- advanced breast cancer patients receiving CDK4/6 inhibitor combined with endocrine therapy |
Primary outcome
Progression-free survival (PFS) From enrollment to progression or death (for any reason) Progression-free survival (PFS)
Time frame: Estimated 24 months
From enrollment to progression or death (for any reason)
3 secondary outcomes
Objective response rate (ORR)
Time frame: Estimated 24 months
Disease Control Rate (DCR)
Time frame: Estimated 24 months
Overall survival (OS)
Time frame: Estimated 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 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.
Questions about this trial
What is this clinical trial studying?
A study testing (CDK)4/6 inhibitor in people with Advanced HR+ HER2 Negative Breast Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital.
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 8 inclusion and 2 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 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Contact Chunfang Hao, PhD (13602031629, haochf@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) From enrollment to progression or death (for any reason) Progression-free survival (PFS) (time frame: Estimated 24 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 29 Sep 2022.