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

NCT05167643 | Unknown

• 1 other identifier: BC-CIH-H-RWS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced HR+ HER2 Negative Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  From enrollment to progression or death (for any reason)

  Estimated 24 months

Secondary Outcomes (4)

• Objective response rate (ORR)

  Estimated 24 months

• Disease Control Rate (DCR)

  Estimated 24 months

• Overall survival (OS)

  Estimated 36 months

• Security (CTCAE 5.0)

  From informed consent through 28 days following treatment completion

Study Arms (1)

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

Drug: Enituzumab injection+Abesili tablets+Anastrozole tablets

Interventions

Enituzumab injection+Abesili tablets+Anastrozole tablets DRUG

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

Trastuzumab injection+Piperacillil tablets+Letrozole tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Cancer Hospital

Tianjin, China

RECRUITING

Study Officials

• Chunfang Hao, PhD

  Department of Breast Cancer Medical Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunfang Hao, PhD

CONTACT

13602031629; haochf@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: December 22, 2021
• Study Start: January 23, 2022
• Primary Completion: October 23, 2022
• Study Completion: August 23, 2024
• Last Updated: April 7, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)