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The Choice of Treatment Methods and Efficacy of LABC

ConditionLocally Advanced Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorPeking Union Medical College Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Factorial

Treatments tested in this trial

  • Modified radical mastectomy for breast cancer

    Procedure/Surgery

    Modified radical mastectomy for breast cancer

  • neoadjuvant therapy

    Procedure/Surgery

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

  • Systematic treatment

    Procedure/Surgery

    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"）

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 2 interventions
Group B: Group BActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

DFS

Disease-free survival of patients with locally advanced breast cancer

Time frame
1 year；3 years；5 years

Secondary outcomes

1

OS

Overall survival of patients with locally advanced breast cancer

Time frame
1 year；3 years；5 years
2

Five year survival rate

Five year survival rate of patients with locally advanced breast cancer

Time frame
1 year；3 years；5 years
3

Local recurrence or distant metastasis rate

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

Time frame
1 year；3 years；5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking Union Medical College Hospital

Lead sponsor

Source ClinicalTrials.gov
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