Advanced HR+ HER2 Negative Breast CarcinomaNCT05167643
H (Trastuzumab or Biosimilar) Combined With CDK4/6 Inhibitor + AI±OFS in the Treatment of HR+HER2+ Advanced Breast Cancer Efficacy and Safety: a Chinese Multi-center Real World Study
A study testing Enituzumab injection+Abesili tablets+Anastrozole tablets in people with Advanced HR+ HER2 Negative Breast Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study is a multi-center prospective real-world clinical study, mainly evaluating the efficacy and safety of H combined with CDK4/6 inhibitor + AI in the treatment of HR+/HER2+ advanced breast cancer; exploring potential biomarkers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced HR+ HER2 Negative Breast Carcinoma
- What is being tested?
- Enituzumab injection+Abesili tablets+Anastrozole tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 23 Jan 2022to 23 Aug 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old.
- HR-positive and HER2-positive breast cancer diagnosed pathologically.
- ER positive and/or PR positive is defined as: the proportion of positively stained tumor cells in all tumor cells is ≥10% (reviewed and confirmed by the investigator at the test center);
- HER2 positive is defined as: standard immunohistochemistry (IHC) test for HER2 (3+), or HER2 (2+), FISH test is positive (reviewed and confirmed by the investigator at the test center).
- After H-based combined chemotherapy treatment has progressed (≤1 line), or the combined treatment is effective but not suitable for continued combined chemotherapy; or initially unsuitable for targeted combined chemotherapy for recurrent metastatic breast cancer or inoperable locally advanced breast cancer Breast cancer patients.
- Postmenopausal or premenopausal/perimenopausal female patients can be included in the group. Premenopausal or perimenopausal female patients must be willing to receive LHRHa treatment during the study period.
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- According to the RECIST 1.1 standard, patients can have: a) measurable lesions; b) without measurable lesions, unmeasurable osteolytic or mixed (osteolytic + osteogenic) bone lesions. c) Unmeasurable lesions.
- The main organs are functioning normally, that is, they meet the following standards:
- The standard of routine blood examination should meet:
- Hb≥80 g/L; ANC≥1.5×109 /L; PLT≥75×109 /L;
- The biochemical inspection shall meet the following standards:
- TBIL≤1.5×ULN (upper limit of normal value); ALT and AST≤2.5×ULN; if there is liver metastasis, ALT and AST≤5×ULN; Serum creatinine ≤1.5×ULN, creatinine clearance ≥50ml/min (based on Cockroft and Gault formula);
- Heart color Doppler ultrasound Left ventricular ejection fraction (LVEF) ≥50%.
Who cannot join
- Patients who have previously received CDK4/6 inhibitor drug therapy.
- T-DM1 treats patients.
- Female patients during pregnancy or lactation.
- Suffer from serious concomitant diseases, such as infectious diseases; there are many factors that affect the oral and absorption of drugs.
- Patients considered by the investigator to be unsuitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Cancer Hospital
Tianjin
Chunfang Hao, PhD, 13602031629, haochf@163.com
About this study
Official title: Exploratory Study of HR-positive HER2-positive MBC Combined Treatment Plan
This study is a multi-center prospective real-world clinical study, mainly evaluating the efficacy and safety of H combined with CDK4/6 inhibitor + AI in the treatment of HR+/HER2+ advanced breast cancer; exploring potential biomarkers.
Read the detailed description
This study is a multi-center, prospective. Because of the non-interventional nature of this study, the choice of H can be trastuzumab, biosimilar drugs Hantriyou, enituzumab, etc. The CDK4/6 inhibitor can be piperazil, abecilil and the like. AI can be letrozole, anastrozole, exemestane. This study does not change or interfere with clinicians' diagnosis and treatment decisions, as well as patients' actual medical practices.This real-world study will not do formal inference statistical analysis. All hypothesis testing is exploratory. A comprehensive statistical analysis plan (SAP) will be prepared and finalized before the data is locked and analyzed. Descriptive statistics will be performed, including the number and percentage of categorical variables, as well as the number, average, standard deviation, median, maximum, and minimum of continuous variables. Kaplan-Meier survival analysis was used to calculate the median PFS and OS and their 95% confidence intervals. The median time to disease progression and median survival time will also be calculated, as well as its 95% confidence interval. ORR and CBR will be analyzed and expressed by the ratio and the corresponding 95% confidence interval (CI). The multivariate logistic regression model was used to calculate the odds ratio (OR) and its 95% confidence interval and p-value. The subgroup analysis of PFS and OS was analyzed by Log-rank test. The COX proportional hazard regression model is used to calculate the hazard ratio and its 95% confidence interval.
- Being tested
- Enituzumab injection+Abesili tablets+Anastrozole tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enituzumab injection+Abesili tablets+Anastrozole tabletsDrug
According to the current clinical guidelines combined with clinical practice, the treating physicians recommended the treatment plan to the subjects, and decided to enroll HR+/HER2+ advanced breast cancer patients treated with H combined with CDK4/6 inhibitor + AI±OFS into this study
| Study group | Role | What they receive |
|---|---|---|
| Trastuzumab injection+Piperacillil tablets+Letrozole tablets | Experimental | Trastuzumab injection:Once in 21 days IVD；Piperacillil tablets:125mg qd (d1-21) PO；Letrozole tablets:2.5mg POqd；According to the current clinical guidelines combined with clinical practice, the treating physicians recommended the treatment plan to the subjects, and decided to enroll HR+/HER2+ advanced breast cancer patients treated with H combined with CDK4/6 inhibitor + AI±OFS into this study Receives: Drug: Enituzumab injection+Abesili tablets+Anastrozole tablets |
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)
Measured: Estimated 24 months
Secondary outcomes (4)
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
Security (CTCAE 5.0)
Adverse events are described in terms of CTCAE 5.0
Measured: From informed consent through 28 days following treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start23 Jan 2022
- Primary completion23 Oct 2022 (estimated)
- Study completion23 Aug 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chunfang Hao, PhD, Principal investigator, Department of Breast Cancer Medical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167643
- Sponsor's protocol ID
- BC-CIH-H-RWS
- Status last verified
- Oct 2021
- First submitted
- 3 Nov 2021
- Last updated
- 7 Apr 2022
- 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 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of HR-positive HER2-positive MBC Combined Treatment Plan
- ClinicalTrials.gov ID
- NCT05167643
- Acronym / sponsor ID
- BC-CIH-H-RWS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 23 Jan 2022 (actual)
- Primary completion
- 23 Oct 2022 (estimated)
- Study completion
- 23 Aug 2024 (estimated)
- First posted
- 22 Dec 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.
This study is a multi-center prospective real-world clinical study, mainly evaluating the efficacy and safety of H combined with CDK4/6 inhibitor + AI in the treatment of HR+/HER2+ advanced breast cancer; exploring potential biomarkers.
Detailed description
This study is a multi-center, prospective. Because of the non-interventional nature of this study, the choice of H can be trastuzumab, biosimilar drugs Hantriyou, enituzumab, etc. The CDK4/6 inhibitor can be piperazil, abecilil and the like. AI can be letrozole, anastrozole, exemestane. This study does not change or interfere with clinicians' diagnosis and treatment decisions, as well as patients' actual medical practices.This real-world study will not do formal inference statistical analysis. All hypothesis testing is exploratory. A comprehensive statistical analysis plan (SAP) will be prepared and finalized before the data is locked and analyzed. Descriptive statistics will be performed, including the number and percentage of categorical variables, as well as the number, average, standard deviation, median, maximum, and minimum of continuous variables. Kaplan-Meier survival analysis was used to calculate the median PFS and OS and their 95% confidence intervals. The median time to disease progression and median survival time will also be calculated, as well as its 95% confidence interval. ORR and CBR will be analyzed and expressed by the ratio and the corresponding 95% confidence interval (CI). The multivariate logistic regression model was used to calculate the odds ratio (OR) and its 95% confidence interval and p-value. The subgroup analysis of PFS and OS was analyzed by Log-rank test. The COX proportional hazard regression model is used to calculate the hazard ratio and its 95% confidence interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trastuzumab injection+Piperacillil tablets+Letrozole tablets | Experimental | Drug: Enituzumab injection+Abesili tablets+Anastrozole tabletsTrastuzumab injection:Once in 21 days IVD；Piperacillil tablets:125mg qd (d1-21) PO；Letrozole tablets:2.5mg POqd；According to the current clinical guidelines combined with clinical practice, the treating physicians recommended the treatment plan to the subjects, and decided to enroll HR+/HER2+ advanced breast cancer patients treated with H combined with CDK4/6 inhibitor + AI±OFS into this study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥ 18 years old.
- HR-positive and HER2-positive breast cancer diagnosed pathologically.
- After H-based combined chemotherapy treatment has progressed (≤1 line), or the combined treatment is effective but not suitable for continued combined chemotherapy; or initially unsuitable for targeted combined chemotherapy for recurrent metastatic breast cancer or inoperable locally advanced breast cancer Breast cancer patients.
- Postmenopausal or premenopausal/perimenopausal female patients can be included in the group. Premenopausal or perimenopausal female patients must be willing to receive LHRHa treatment during the study period.
- According to the RECIST 1.1 standard, patients can have: a) measurable lesions; b) without measurable lesions, unmeasurable osteolytic or mixed (osteolytic + osteogenic) bone lesions. c) Unmeasurable lesions.
Key exclusion criteria (5 listed)
- Patients who have previously received CDK4/6 inhibitor drug therapy.
- T-DM1 treats patients.
- Female patients during pregnancy or lactation.
- Suffer from serious concomitant diseases, such as infectious diseases; there are many factors that affect the oral and absorption of drugs.
- Patients considered by the investigator to be unsuitable to participate in this study.
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 |
|---|---|---|
| Enituzumab injection+Abesili tablets+Anastrozole tabletsAccording to the current clinical guidelines combined with clinical practice, the treating physicians recommended the treatment plan to the subjects, and decided to enroll HR+/HER2+ advanced breast cancer patients treated with H combined with CDK4/6 inhibitor + AI±OFS into this study | Drug | Trastuzumab injection+Piperacillil tablets+Letrozole tablets |
Primary outcome
Progression-free survival (PFS)
Time frame: Estimated 24 months
From enrollment to progression or death (for any reason)
4 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
Security (CTCAE 5.0)
Time frame: From informed consent through 28 days following treatment completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- 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.
Chunfang Hao, PhD principal investigator
Department of Breast Cancer Medical Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enituzumab injection+Abesili tablets+Anastrozole tablets in people with Advanced HR+ HER2 Negative Breast Carcinoma, 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 13 inclusion and 5 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 7 Apr 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.
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) (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 7 Apr 2022.