NCT06080620

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Oct 2023Aug 2026

First Submitted

Initial submission to the registry

September 21, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

October 8, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

September 21, 2023

Last Update Submit

October 6, 2023

Conditions

Locally Advanced Breast Cancer

Keywords

Locally Advanced Breast Cancerprognosis

Outcome Measures

Primary Outcomes (1)

  • DFS

    Disease-free survival of patients with locally advanced breast cancer

    1 year；3 years；5 years

Secondary Outcomes (3)

  • OS

    1 year；3 years；5 years

  • Five year survival rate

    1 year；3 years；5 years

  • Local recurrence or distant metastasis rate

    1 year；3 years；5 years

Study Arms (2)

Group A

EXPERIMENTAL

Surgery+systematic treatment

Procedure: Modified radical mastectomy for breast cancerProcedure: Systematic treatment

Group B

ACTIVE COMPARATOR

Neoadjuvant therapy+surgery+systematic treatment

Procedure: Modified radical mastectomy for breast cancerProcedure: neoadjuvant therapyProcedure: Systematic treatment

Interventions

Modified radical mastectomy for breast cancerPROCEDURE

Modified radical mastectomy for breast cancer

Group AGroup B
neoadjuvant therapyPROCEDURE

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

Group B
Systematic treatmentPROCEDURE

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"）

Group AGroup B

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ying Xu

Beijing, 100730, China

RECRUITING

MeSH Terms

Interventions

Mastectomy, Modified RadicalNeoadjuvant Therapy

Intervention Hierarchy (Ancestors)

Mastectomy, RadicalMastectomySurgical Procedures, OperativeCombined Modality TherapyTherapeutics

Study Officials

  • Yan Lin

    Peking Union Medical College Hospital

    STUDY CHAIR

Central Study Contacts

Ying Xu

CONTACT

+861069158721xuying@pumch.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: The plan for Group A (experimental group) is "surgery+systematic treatment"; The plan for Group B (control group) is "neoadjuvant therapy+surgery+systematic treatment".
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2023

First Posted

October 12, 2023

Study Start

October 8, 2023

Primary Completion

October 1, 2025

Study Completion (Estimated)

August 1, 2026

Last Updated

October 12, 2023

Record last verified: 2023-10

Locations

CN(1)