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Compare the Efficacy of Surgery Combined With Systemic Therapy and Pure Systemic Therapy in Breast Cancer Patients

Primary Purpose

Stage IV Breast Cancer

Status
Withdrawn
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
surgery combined with systemic therapy
systemic therapy
Sponsored by
Henan Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IV Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • • Sign the informed consent

    • ages 18-70, female;
    • Breast cancer meets the following criteria:
  • Histologically diagnosed invasive breast cancer, measure distant metastases with local standard assessment methods;

  • Known hormone receptors and HER-2 status (ER, PR and HER2);

    • Eastern Cooperative Oncology Group (ECOG) performance status score ≤1;
    • Estimated patient survival beyond 1 year;
    • The time from diagnosis or systemic treatment to randomization does not exceed 1 year;
    • According to RECIST 1.1, patients receiving chemotherapy or endocrine therapy are effective, including complete remission, partial remission, or stabilization. If the patient only receives endocrine therapy, the time is not less than 6 months; when receiving chemotherapy, the number of cycles is not less than 4 cycles;
    • HER2-positive patients: the proportion of patients receiving targeted therapy is not less than 80% of the total HER2-positive patients;
    • Patients had no obvious surgical contraindications before randomization;
    • Researchers judge that they can comply with the research protocol

Exclusion Criteria:

  • • Double breast cancer;

    • Progression of metastases after systemic treatment;
    • Poorly controlled brain metastases, liver metastases and multiple metastases;
    • History of local breast radiotherapy after diagnosis;
    • Have a history of other malignancies within 5 years prior to screening, with cervical cancer in situ treated properly except for non-melanoma skin cancer or stage I uterine cancer;
    • Have undergone a major breast cancer-free surgical procedure within 4 weeks before randomization, or the patient has not fully recovered from such a surgical procedure;
    • Have severe comorbidities or other comorbid conditions that interfere with planned treatment, or any other condition in which the investigator does not consider the patient suitable for participation in the study.
    • Patients can withdraw informed consent at any time;
    • pregnancy;
    • The sponsor has determined that a major protocol violation that could compromise patient safety;
    • Patients' non-compliance with protocol requirements on multiple occasions;
    • The investigator believes that withdrawal from the trial will be of greatest benefit to the patient.

Sites / Locations

  • Henan Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

surgery combined with systemic therapy

systemic therapy

Arm Description

surgery combined with systemic therapy

systemic therapy

Outcomes

Primary Outcome Measures

OS
The time from diagnosis to death

Secondary Outcome Measures

PFS
The time from randomization to disease progression or death, including local PFS and distant PFS Local PFS refers to the time from randomization of patients to local or regional lymph node recurrence in the surgical group or local or regional lymph node progression in the non-surgical group. distant PFS refers to the time from randomization of a patient to local or distant distant disease progression or death.
BCSS (Breast Cancer Specific Survival)
The time from the random start of a patient to death due to breast cancer, excluding deaths caused by other causes

Full Information

First Posted
December 12, 2019
Last Updated
November 28, 2022
Sponsor
Henan Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04199520
Brief Title
Compare the Efficacy of Surgery Combined With Systemic Therapy and Pure Systemic Therapy in Breast Cancer Patients
Official Title
Compare the Efficacy of Surgery Combined With Systemic Therapy and Pure Systemic Therapy in Patients With Stage Ⅳ Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Withdrawn
Why Stopped
In clinical treatment, most patients with stage IV breast cancer received surgical treatment, which made it difficult to enroll this project, so this study was terminated.
Study Start Date
April 15, 2020 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henan Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the effect of primary resection combined with systemic therapy and pure systemic therapy on the overall survival of patients with stage Ⅳ breast cancer.
Detailed Description
In developing countries, the proportion of breast cancer patients who have a stage IV diagnosis at the first diagnosis can be as high as 25%. For advanced breast cancer, previous views have suggested that surgery as one of the palliative treatments does not improve patient survival. The proportion of patients undergoing surgery for stage IV breast cancer has gradually decreased over the past 30 years. At present, there is still no clear recommendation and guidance in common clinical guidelines for the primary surgery for stage IV breast cancer. Some retrospective studies suggest that surgery can improve the survival of advanced breast cancer, but the results of prospective studies are inconclusive, and surgery is still not a routine choice for stage IV breast cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
surgery combined with systemic therapy
Arm Type
Experimental
Arm Description
surgery combined with systemic therapy
Arm Title
systemic therapy
Arm Type
Active Comparator
Arm Description
systemic therapy
Intervention Type
Combination Product
Intervention Name(s)
surgery combined with systemic therapy
Intervention Description
surgery combined with systemic therapy
Intervention Type
Other
Intervention Name(s)
systemic therapy
Intervention Description
systemic therapy
Primary Outcome Measure Information:
Title
OS
Description
The time from diagnosis to death
Time Frame
up to 2 year
Secondary Outcome Measure Information:
Title
PFS
Description
The time from randomization to disease progression or death, including local PFS and distant PFS Local PFS refers to the time from randomization of patients to local or regional lymph node recurrence in the surgical group or local or regional lymph node progression in the non-surgical group. distant PFS refers to the time from randomization of a patient to local or distant distant disease progression or death.
Time Frame
up to 2 year
Title
BCSS (Breast Cancer Specific Survival)
Description
The time from the random start of a patient to death due to breast cancer, excluding deaths caused by other causes
Time Frame
up to 2 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Sign the informed consent ages 18-70, female; Breast cancer meets the following criteria: Histologically diagnosed invasive breast cancer, measure distant metastases with local standard assessment methods; Known hormone receptors and HER-2 status (ER, PR and HER2); Eastern Cooperative Oncology Group (ECOG) performance status score ≤1; Estimated patient survival beyond 1 year; The time from diagnosis or systemic treatment to randomization does not exceed 1 year; According to RECIST 1.1, patients receiving chemotherapy or endocrine therapy are effective, including complete remission, partial remission, or stabilization. If the patient only receives endocrine therapy, the time is not less than 6 months; when receiving chemotherapy, the number of cycles is not less than 4 cycles; HER2-positive patients: the proportion of patients receiving targeted therapy is not less than 80% of the total HER2-positive patients; Patients had no obvious surgical contraindications before randomization; Researchers judge that they can comply with the research protocol Exclusion Criteria: • Double breast cancer; Progression of metastases after systemic treatment; Poorly controlled brain metastases, liver metastases and multiple metastases; History of local breast radiotherapy after diagnosis; Have a history of other malignancies within 5 years prior to screening, with cervical cancer in situ treated properly except for non-melanoma skin cancer or stage I uterine cancer; Have undergone a major breast cancer-free surgical procedure within 4 weeks before randomization, or the patient has not fully recovered from such a surgical procedure; Have severe comorbidities or other comorbid conditions that interfere with planned treatment, or any other condition in which the investigator does not consider the patient suitable for participation in the study. Patients can withdraw informed consent at any time; pregnancy; The sponsor has determined that a major protocol violation that could compromise patient safety; Patients' non-compliance with protocol requirements on multiple occasions; The investigator believes that withdrawal from the trial will be of greatest benefit to the patient.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiujun Zhu
Organizational Affiliation
Henan Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China

12. IPD Sharing Statement

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Compare the Efficacy of Surgery Combined With Systemic Therapy and Pure Systemic Therapy in Breast Cancer Patients

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