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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Stage IV Breast Cancer
• Intervention / Treatment: Combination product: surgery combined with systemic therapy; Other: systemic therapy

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: surgery combined with systemic therapy	Combination product: surgery combined with systemic therapy; surgery combined with systemic therapy
Active Comparator: systemic therapy	Other: systemic therapy; systemic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	The time from diagnosis to death	up to 2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 2 year
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	up to 2 year

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital
• Investigators: Principal Investigator: Jiujun Zhu, Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2020
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 16, 2019

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: HNCH-BC003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No