Locally Advanced Breast CancerNCT06080620
The Choice of Treatment Methods and Efficacy of LABC
A study testing Modified radical mastectomy for breast cancer, neoadjuvant therapy and Systematic treatment in people with Locally Advanced Breast Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Locally Advanced Breast Cancer
- What is being tested?
- Modified radical mastectomy for breast cancer, neoadjuvant therapy and Systematic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2023to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ying Xu
Beijing, 100730
Ying Xu, +861069158721
About this study
Official title: Treatment Selection and Efficacy of Locally Advanced Breast cancer-a Prospective Randomized Controlled Study
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.
Read the detailed description
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.
- Conditions
- Locally Advanced Breast Cancer
- Being tested
- Modified radical mastectomy for breast cancer, neoadjuvant therapy, Systematic treatment
- Keywords
- Locally Advanced Breast Cancer, prognosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified radical mastectomy for breast cancerProcedure or surgery
Modified radical mastectomy for breast cancer
neoadjuvant therapyProcedure or surgery
neoadjuvant chemotherapy（Drugs：" Doxorubicin""Paclitaxel""Albumin paclitaxel""Cyclophosphamide"）, endocrine therapy（Drugs："Toremifen""Zoladex""Aromatase inhibitors"）, targeted therapy（Drugs："trastuzumab""Pertuzumab"）
Systematic treatmentProcedure or 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"）
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Surgery+systematic treatment Receives: Procedure: Modified radical mastectomy for breast cancer; Procedure: Systematic treatment |
| Group B | Active comparator | Neoadjuvant therapy+surgery+systematic treatment Receives: Procedure: Modified radical mastectomy for breast cancer; Procedure: neoadjuvant therapy; Procedure: Systematic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
Disease-free survival of patients with locally advanced breast cancer
Measured: 1 year；3 years；5 years
Secondary outcomes (3)
OS
Overall survival of patients with locally advanced breast cancer
Measured: 1 year；3 years；5 years
Five year survival rate
Five year survival rate of patients with locally advanced breast cancer
Measured: 1 year；3 years；5 years
Local recurrence or distant metastasis rate
Local recurrence or distant metastasis rate of patients with locally advanced breast cancer
Measured: 1 year；3 years；5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start8 Oct 2023 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The plan for Group A (experimental group) is "surgery+systematic treatment"; The plan for Group B (control group) is "neoadjuvant therapy+surgery+systematic treatment".
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Lin, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080620
- Sponsor's protocol ID
- PUMCH-LABC study
- Status last verified
- Oct 2023
- First submitted
- 21 Sep 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Selection and Efficacy of Locally Advanced Breast cancer-a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06080620
- Acronym / sponsor ID
- PUMCH-LABC study
- Conditions
- Locally Advanced Breast Cancer
- Keywords
- Locally Advanced Breast Cancer, prognosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 8 Oct 2023 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The plan for Group A (experimental group) is "surgery+systematic treatment"; The plan for Group B (control group) is "neoadjuvant therapy+surgery+systematic treatment".
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Modified radical mastectomy for breast cancer, Procedure: Systematic treatmentSurgery+systematic treatment |
| Group B | Active comparator | Procedure: Modified radical mastectomy for breast cancer, Procedure: neoadjuvant therapy, Procedure: Systematic treatmentNeoadjuvant therapy+surgery+systematic treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified radical mastectomy for breast cancerModified radical mastectomy for breast cancer | Procedure or surgery | Group A, Group B |
| neoadjuvant therapyneoadjuvant chemotherapy（Drugs：" Doxorubicin""Paclitaxel""Albumin paclitaxel""Cyclophosphamide"）, endocrine therapy（Drugs："Toremifen""Zoladex""Aromatase inhibitors"）, targeted therapy（Drugs："trastuzumab""Pertuzumab"） | Procedure or surgery | Group B |
| Systematic treatmentchemotherapyDrugs：" 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"） | Procedure or surgery | Group A, Group B |
Primary outcome
DFS
Time frame: 1 year；3 years；5 years
Disease-free survival of patients with locally advanced breast cancer
3 secondary outcomes
OS
Time frame: 1 year；3 years；5 years
Five year survival rate
Time frame: 1 year；3 years；5 years
Local recurrence or distant metastasis rate
Time frame: 1 year；3 years；5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Lin study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified radical mastectomy for breast cancer, neoadjuvant therapy and Systematic treatment in people with Locally Advanced Breast Cancer, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Xu (+861069158721, xuying@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (time frame: 1 year；3 years；5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.