Breast CancerPhase 2/3NCT06769919
A Randomized Controlled Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined with Systemic Therapy for Early-stage Breast Cancer
A Phase 2/3 study testing Neoadjuvant radiotherapy in people with Breast Cancer, run by Xijing Hospital at 1 site in China.
Trial summary
A total of 340 early-stage breast cancer patients with axillary lymph node biopsy-confirmed positivity were enrolled and divided into two groups. The control group received neoadjuvant systemic therapy followed by surgery and adjuvant radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Neoadjuvant radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2024to 31 Dec 2031
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged ≥18 years and ≤65 years；
- newly diagnosed breast cancer;
- Axillary lymph node biopsy-positive;
- ECOG performance status score of 0-1;
Who cannot join
- metastatic breast cancer or bilateral breast cancer;
- inflammatory breast cancer;
- Pregnancy and Lactation;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xijing hospital
Xi'an, Shaanxi, 710032
Ju liang Zhang, 029-84775271, vascularzhang@163.com
About this study
A total of 340 early-stage breast cancer patients with axillary lymph node biopsy-confirmed positivity were enrolled and divided into two groups. The control group received neoadjuvant systemic therapy followed by surgery and adjuvant radiotherapy. The experimental group received neoadjuvant systemic therapy and neoadjuvant radiotherapy followed by surgery. The treatment response of breast cancer, patient survival time, and treatment safety were subsequently evaluated.
Read the detailed description
This study is a randomized, controlled, open-label clinical trial, planned to enroll 340 early-stage breast cancer patients with axillary lymph node biopsy-confirmed positivity. Participants will be divided into two groups. The control group will receive neoadjuvant systemic therapy, followed by surgery and adjuvant radiotherapy. The experimental group will receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery.
After providing full informed consent and signing the informed consent form, eligible participants will enter the trial period upon screening. Within 72 hours of enrollment confirmation, participants will begin neoadjuvant therapy. Patients in the control group will receive a neoadjuvant systemic therapy regimen selected by their physician, followed by surgery and adjuvant radiotherapy. Patients in the experimental group will receive both neoadjuvant systemic therapy and neoadjuvant radiotherapy. The radiotherapy regions will include the whole breast, supraclavicular and infraclavicular areas, and internal mammary regions, with a dose of 50 Gy over 25 fractions, plus a tumor bed boost of 10-16 Gy over 4-8 fractions.
Primary Endpoint:
Residual Cancer Burden (RCB) 0/I.
Secondary Endpoints:
Event-Free Survival (EFS) Invasive Disease-Free Survival (iDFS) Overall Survival (OS) Quality of life scores ECOG performance status scores Surgical incision healing scores Adverse Events (AEs)
Inclusion Criteria:
Participants must meet all of the following criteria to be eligible for the trial:
- Female patients aged ≥18 years and ≤65 years with newly diagnosed breast cancer;
- Early-stage or locally advanced invasive breast cancer confirmed by histopathology according to the latest ASCO/CAP guidelines, meeting the following conditions:Axillary lymph node biopsy-positive;ECOG performance status score of 0-1;
- Presence of at least one measurable lesion based on RECIST 1.1 criteria.
- Conditions
- Breast Cancer
- Being tested
- Neoadjuvant radiotherapy
- Keywords
- radiotherapy, system therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant radiotherapyRadiation
The experimental group will receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant radiotherapy | No intervention | receive neoadjuvant systemic therapy, followed by surgery and adjuvant radiotherapy |
| Neoadjuvant radiotherapy | Experimental | receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery Receives: Radiation: Neoadjuvant radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual Cancer Burden (RCB) 0/I
Residual Cancer Burden (RCB) is a standardized method used to quantify the amount of residual disease in breast cancer patients after neoadjuvant therapy (treatment given before surgery). It is calculated based on the size of the primary tumor, the cellularity of the tumor bed, and the extent of lymph node involvement. RCB is divided into four categories:
RCB-0: Pathologic complete response (pCR), meaning no residual invasive cancer is found in the breast or lymph nodes.
RCB-I: Minimal residual disease, indicating a very small amount of cancer remains after treatment.
RCB-II: Moderate residual disease. RCB-III: Extensive residual disease. RCB-0 and RCB-I are often associated with better prognoses and higher survival rates compared to RCB-II and RCB-III
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (7)
Event-Free Survival (EFS)
Event-Free Survival (EFS) is defined as the time from randomization to the occurrence of any event, including disease progression, discontinuation of treatment for any reason, or death.
Measured: From enrollment to 10 years later or death.
Invasive Disease-Free Survival (iDFS)
Measured: From enrollment to 10 years later or death.
Overall Survival (OS)
Measured: From enrollment to 10 years later or death.
Quality of life scores
Measured: From enrollment to 3 years after treatment completion.
ECOG performance status scores
Measured: From enrollment to 3 years after treatment completion.
Surgical incision healing scores
Measured: From enrollment to 1 years after treatment completion.
Adverse Events (AEs)
Measured: From enrollment to 3 years after treatment completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start31 Dec 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Xijing 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized, controlled, open-label clinical trial, planned to enroll 340 early-stage breast cancer patients with axillary lymph node biopsy-confirmed positivity. Participants will be divided into two groups. The control group will receive neoadjuvant systemic therapy, followed by surgery and adjuvant radiotherapy. The experimental group will receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery.
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769919
- Sponsor's protocol ID
- WZ-1
- Status last verified
- Dec 2024
- First submitted
- 3 Jan 2025
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined with Systemic Therapy for Early-stage Breast Cancer
- ClinicalTrials.gov ID
- NCT06769919
- Acronym / sponsor ID
- WZ-1
- Conditions
- Breast Cancer
- Keywords
- radiotherapy, system therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 31 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 10 Jan 2025 (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.
A total of 340 early-stage breast cancer patients with axillary lymph node biopsy-confirmed positivity were enrolled and divided into two groups. The control group received neoadjuvant systemic therapy followed by surgery and adjuvant radiotherapy. The experimental group received neoadjuvant systemic therapy and neoadjuvant radiotherapy followed by surgery. The treatment response of breast cancer, patient survival time, and treatment safety were subsequently evaluated.
Detailed description
This study is a randomized, controlled, open-label clinical trial, planned to enroll 340 early-stage breast cancer patients with axillary lymph node biopsy-confirmed positivity. Participants will be divided into two groups. The control group will receive neoadjuvant systemic therapy, followed by surgery and adjuvant radiotherapy. The experimental group will receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery.
After providing full informed consent and signing the informed consent form, eligible participants will enter the trial period upon screening. Within 72 hours of enrollment confirmation, participants will begin neoadjuvant therapy. Patients in the control group will receive a neoadjuvant systemic therapy regimen selected by their physician, followed by surgery and adjuvant radiotherapy. Patients in the experimental group will receive both neoadjuvant systemic therapy and neoadjuvant radiotherapy. The radiotherapy regions will include the whole breast, supraclavicular and infraclavicular areas, and internal mammary regions, with a dose of 50 Gy over 25 fractions, plus a tumor bed boost of 10-16 Gy over 4-8 fractions.
Primary Endpoint:
Residual Cancer Burden (RCB) 0/I.
Secondary Endpoints:
Event-Free Survival (EFS) Invasive Disease-Free Survival (iDFS) Overall Survival (OS) Quality of life scores ECOG performance status scores Surgical incision healing scores Adverse Events (AEs)
Inclusion Criteria:
Participants must meet all of the following criteria to be eligible for the trial:
- Female patients aged ≥18 years and ≤65 years with newly diagnosed breast cancer;
- Early-stage or locally advanced invasive breast cancer confirmed by histopathology according to the latest ASCO/CAP guidelines, meeting the following conditions:Axillary lymph node biopsy-positive;ECOG performance status score of 0-1;
- Presence of at least one measurable lesion based on RECIST 1.1 criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a randomized, controlled, open-label clinical trial, planned to enroll 340 early-stage breast cancer patients with axillary lymph node biopsy-confirmed positivity. Participants will be divided into two groups. The control group will receive neoadjuvant systemic therapy, followed by surgery and adjuvant radiotherapy. The experimental group will receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery.
| Arm | Type | Receives |
|---|---|---|
| Adjuvant radiotherapy | No intervention | –receive neoadjuvant systemic therapy, followed by surgery and adjuvant radiotherapy |
| Neoadjuvant radiotherapy | Experimental | Radiation: Neoadjuvant radiotherapyreceive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients aged ≥18 years and ≤65 years；
- newly diagnosed breast cancer;
- Axillary lymph node biopsy-positive;
- ECOG performance status score of 0-1;
Key exclusion criteria (3 listed)
- metastatic breast cancer or bilateral breast cancer;
- inflammatory breast cancer;
- Pregnancy and Lactation;
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 |
|---|---|---|
| Neoadjuvant radiotherapyThe experimental group will receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery | Radiation | Neoadjuvant radiotherapy |
Primary outcome
Residual Cancer Burden (RCB) 0/I
Time frame: From enrollment to the end of treatment at 8 weeks
Residual Cancer Burden (RCB) is a standardized method used to quantify the amount of residual disease in breast cancer patients after neoadjuvant therapy (treatment given before surgery). It is calculated based on the size of the primary tumor, the cellularity of the tumor bed, and the extent of lymph node involvement. RCB is divided into four categories: RCB-0: Pathologic complete response (pCR), meaning no residual invasive cancer is found in the breast or lymph nodes. RCB-I: Minimal residual disease, indicating a very small amount of cancer remains after treatment. RCB-II: Moderate residual disease. RCB-III: Extensive residual disease. RCB-0 and RCB-I are often associated with better prognoses and higher survival rates compared to RCB-II and RCB-III
7 secondary outcomes
Event-Free Survival (EFS)
Time frame: From enrollment to 10 years later or death.
Invasive Disease-Free Survival (iDFS)
Time frame: From enrollment to 10 years later or death.
Overall Survival (OS)
Time frame: From enrollment to 10 years later or death.
Quality of life scores
Time frame: From enrollment to 3 years after treatment completion.
ECOG performance status scores
Time frame: From enrollment to 3 years after treatment completion.
Surgical incision healing scores
Time frame: From enrollment to 1 years after treatment completion.
Adverse Events (AEs)
Time frame: From enrollment to 3 years after treatment completion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Neoadjuvant radiotherapy in people with Breast Cancer, run by Xijing 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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 10 Jan 2025. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ju liang Zhang (029-84775271, vascularzhang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual Cancer Burden (RCB) 0/I (time frame: From enrollment to the end of treatment at 8 weeks). 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 10 Jan 2025.