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NCT Number: NCT06080620

The Choice of Treatment Methods and Efficacy of LABC

The goal of this clinical trial is to compare the therapeutic effects of chemotherapy followed by surgery and surgery followed by chemotherapy in patients with locally advanced breast cancer(LABC). Patients with LABC will be randomly divided into two groups, each receiving chemotherapy followed by surgery or surgery followed by chemotherapy. The main comparison was between the disease-free survival (DFS) of two groups of patients, with the secondary study endpoint being overall survival (OS); Five year survival; Local recurrence or distant metastasis rate.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ying Xu

Beijing, 100730, China

Location status: Recruiting

Location contact

Ying Xu

CONTACT

+861069158721

About this study

Local advanced breast cancer was enrolled in the Department of Breast Surgery of Peking Union Medical College Hospital and Beijing Cooperation Hospital according to the criteria for patient inclusion. It is estimated that 50 patients will be enrolled. Randomly divide patients into two groups. The plan for Group A (experimental group, 25 cases) is "surgery+systematic treatment"; The plan for Group B (control group, 25 cases) is "neoadjuvant therapy+surgery+systematic treatment". Based on the previously obtained patient personal information, treatment related information, tumor tissue/blood sample test results, statistical analysis was conducted to explore the impact of different treatment strategies for locally advanced breast cancer on the survival and prognosis of patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-70 year old female
  • Patients with locally advanced breast cancer (stage IIIb - IIIc) first diagnosed;
  • Clinical diagnosis of breast cancer, or puncture pathology suggests breast cancer;
  • After evaluation by experienced clinical physicians, the patient's tumor has the possibility of surgical resection. Specific evaluation indicators include ultrasound assessment of the tumor not surrounding the axillary vein;
  • Accept treatment plans including surgery, radiotherapy, and chemotherapy;
  • Volunteer to participate in clinical research and sign an informed consent form;
  • Willing to undergo follow-up and complete quality of life (EQ-5D series scale and FACT-B scale) and postoperative psychological status (Anxiety/Depression Self Rating Scale) assessments;

Exclusion criteria

  • Patients under 18 years old or over 70 years old;
  • Those who have received breast cancer related surgery, radiotherapy or chemotherapy;
  • Those who are not expected to receive surgery, radiotherapy or chemotherapy related to breast cancer
  • History of other malignant tumors;
  • Pregnant or lactating women;
  • Accompanying active infection and fever;
  • Other serious diseases that may significantly affect clinical trial compliance, such as severe cardiopulmonary dysfunction, liver and kidney dysfunction, poorly controlled diabetes and mental illness.

Treatment and study plan

Modified radical mastectomy for breast cancer

Procedure

Modified radical mastectomy for breast cancer

neoadjuvant therapy

Procedure

neoadjuvant chemotherapy(Drugs:" Doxorubicin""Paclitaxel""Albumin paclitaxel""Cyclophosphamide"), endocrine therapy(Drugs:"Toremifen""Zoladex""Aromatase inhibitors"), targeted therapy(Drugs:"trastuzumab""Pertuzumab")

Systematic treatment

Procedure

chemotherapyDrugs:" Doxorubicin""Paclitaxel""Albumin paclitaxel""Cyclophosphamide"), endocrine therapy(Drugs:"Toremifen""Zoladex""Aromatase inhibitors"), targeted therapy(Drugs:"trastuzumab""Pertuzumab"),radiotherapy("Yikeda Versa HD linear accelerator""Varian Trilogy linear accelerator")

Primary outcomes

  1. DFS

    Time frame: 1 year;3 years;5 years

    Disease-free survival of patients with locally advanced breast cancer

Secondary outcomes

  1. OS

    Time frame: 1 year;3 years;5 years

    Overall survival of patients with locally advanced breast cancer

  2. Five year survival rate

    Time frame: 1 year;3 years;5 years

    Five year survival rate of patients with locally advanced breast cancer

  3. Local recurrence or distant metastasis rate

    Time frame: 1 year;3 years;5 years

    Local recurrence or distant metastasis rate of patients with locally advanced breast cancer

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Treatment Selection and Efficacy of Locally Advanced Breast cancer-a Prospective Randomized Controlled Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 12, 2023
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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