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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

Primary Purpose

Advanced HR+ HER2 Negative Breast Carcinoma

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Enituzumab injection+Abesili tablets+Anastrozole tablets

About this trial

This is an interventional treatment trial for Advanced HR+ HER2 Negative Breast Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years old.
HR-positive and HER2-positive breast cancer diagnosed pathologically.
1. 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);
2. 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.
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:
1. The standard of routine blood examination should meet:
  Hb≥80 g/L; ANC≥1.5×109 /L; PLT≥75×109 /L;
2. 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);
3. Heart color Doppler ultrasound Left ventricular ejection fraction (LVEF) ≥50%.

Exclusion Criteria:

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.

Sites / Locations

Tianjin Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trastuzumab injection+Piperacillil tablets+Letrozole tablets

Arm Description

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

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)

From enrollment to progression or death (for any reason)

Secondary Outcome Measures

Objective response rate (ORR)

Ratio of CR and PR in all subjects

Disease Control Rate (DCR)

Ratio of CR ,PR and SD in all subjects

Overall survival (OS)

From enrollment to death (for any reason)

Security (CTCAE 5.0)

Adverse events are described in terms of CTCAE 5.0

Full Information

NCT ID

NCT05167643

First Posted

November 3, 2021

Last Updated

April 6, 2022

Sponsor

Tianjin Medical University Cancer Institute and Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05167643

Brief Title

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

Official Title

Exploratory Study of HR-positive HER2-positive MBC Combined Treatment Plan

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Recruiting

Study Start Date

January 23, 2022 (Actual)

Primary Completion Date

October 23, 2022 (Anticipated)

Study Completion Date

August 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced HR+ HER2 Negative Breast Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Trastuzumab injection+Piperacillil tablets+Letrozole tablets

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Enituzumab injection+Abesili tablets+Anastrozole tablets

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression-free survival (PFS)

Description

From enrollment to progression or death (for any reason)

Time Frame

Estimated 24 months

Secondary Outcome Measure Information:

Title

Objective response rate (ORR)

Description

Ratio of CR and PR in all subjects

Time Frame

Estimated 24 months

Title

Disease Control Rate (DCR)

Description

Ratio of CR ,PR and SD in all subjects

Time Frame

Estimated 24 months

Title

Overall survival (OS)

Description

From enrollment to death (for any reason)

Time Frame

Estimated 36 months

Title

Security (CTCAE 5.0)

Description

Adverse events are described in terms of CTCAE 5.0

Time Frame

From informed consent through 28 days following treatment completion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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%. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chunfang Hao, PhD

Phone

13602031629

haochf@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chunfang Hao, PhD

Organizational Affiliation

Department of Breast Cancer Medical Oncology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tianjin Cancer Hospital

City

Tianjin

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chunfang Hao, PhD

Phone

13602031629

haochf@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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