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

NCT04199520 | Withdrawn Phase 2

• 1 other identifier: HNCH-BC003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage IV Breast Cancer

Outcome Measures

Primary Outcomes (1)

• OS

  The time from diagnosis to death

  up to 2 year

Secondary Outcomes (2)

• PFS

  up to 2 year

• BCSS (Breast Cancer Specific Survival)

  up to 2 year

Study Arms (2)

surgery combined with systemic therapy

EXPERIMENTAL

surgery combined with systemic therapy

Combination Product: surgery combined with systemic therapy

systemic therapy

ACTIVE COMPARATOR

systemic therapy

Other: systemic therapy

Interventions

surgery combined with systemic therapy COMBINATION_PRODUCT

surgery combined with systemic therapy

surgery combined with systemic therapy

systemic therapy OTHER

systemic therapy

systemic therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jiujun Zhu

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 16, 2019
• Study Start: April 15, 2020
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: March 4, 2024

Record last verified: 2019-12

Locations

CN (1)