Breast CancerPhase 2NCT06498154
Eliminating Breast Surgery for Breast Cancer Patients With Clinical Complete Response to Neoadjuvant Systemic Therapy
A Phase 2 study testing Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy in people with Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Phase II multicenter prospective study on the safety of eliminating surgery for triple negative or HER2 positive breast cancer patients with clinical response to neoadjuvant radiotherapy and neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 25 Jul 2024to 30 Jun 2032
- Phase
- Phase 2
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female initial treatment patients aged ≥ 18 years and ≤ 70 years old
- ECOG score 0-1
- Clinical T1-2N0 HER2 positive ( HR negative HER2 IHC score of 3+, or 2+and ISH test positive) or triple negative invasive breast cancer
- Left ventricular ejection fraction (LVEF) ≥ 50%
- 12 lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method for females<470ms
- The functional level of the main organs must meet the following requirements: blood routine: ANC ≥ 1.5 × 109/L# PLT≥90 × 109/L# Hb≥90 g/L#Blood biochemistry: TBIL ≤ 2.5 × ULN# ALT and AST ≤ 2.5 × ULN# BUN and Cr ≤ 1.5 × ULN#
- For female subjects who have not undergone menopause or surgical sterilization, during the treatment period and during the study treatment
- Agree to abstain or use effective contraceptive methods for at least 2 months after the next administration; .Volunteer to join this study, sign informed consent, have good compliance, and be willing to cooperate with follow-up.
Who cannot join
- Inflammatory breast cancer
- Metastatic tumor
- Previous or concurrent malignant tumors, whose natural history or treatment may interfere with the safety of the research protocol.
- Active infections that require systemic treatment
- Has used any medication in this study within 14 days prior to enrollment
- Major surgery (excluding biopsy) performed within 14 days before enrollment
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, 1 recruiting
- Recruiting
Tianjin medical university cancer institute and hospital
Tianjin
Xuchen Cao, MD, 8618622221160, caoxuchen@tmu.edu.cn
About this study
Official title: Eliminating Breast Surgery for Triple Negative or HR-/HER2+ Breast Cancer Patients With Clinical Complete Response to Combined Neoadjuvant Chemotherapy and Neoadjuvant Radiotherapy: A Multicenter, Phase 2 Trial (EBCS)
Phase II multicenter prospective study on the safety of eliminating surgery for triple negative or HER2 positive breast cancer patients with clinical response to neoadjuvant radiotherapy and neoadjuvant chemotherapy.
Read the detailed description
The main purpose: To explore the safety of eliminating surgery for triple negative or HER2 positive breast cancer patients with clinical response to neoadjuvant chemoradiotherapy. Secondary study objective: To explore predictive molecular biomarkers of response to neoadjuvant chemoradiotherapy and investigate whether ctDNA can predict pCR or survival outcome.
Primary endpoint: 5-year event-free survival (5-year EFS). Secondary end points: Whether combined neoadjuvant chemoradiotherapy can improve breast pathological complete response rate (bpCR: ypT0), overall survival (OS), patient-reported outcomes (PROs) and safety
- Conditions
- Breast Cancer
- Being tested
- Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy
- 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 Chemotherapy combined with Neoadjuvant RadiotherapyRadiation
Neoadjuvant radiotherapy: whole-breast irradiation ( 50 Gy in 25 fractions) plus a mandatory boost (14 Gy in seven fractions, which began on the day following completion of whole-breast irradiation) TCb (HP) * : Triple negative patients will receive TCb regimens with or without immunotherapy and HER2 positive patients will receive TCb(HP) regimens.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy | Experimental | Patients who meet the criteria for enrollment initially receive four cycles of TCb (HP) * neoadjuvant chemotherapy, followed by neoadjuvant radiotherapy starting from the fifth cycle of TCb (HP) * neoadjuvant chemotherapy. After completion of six cycles of neoadjuvant chemotherapy, patients underwent breast magnetic resonance imaging. When a patient meets the MRI criteria suggestive of a complete clinical response (cCR), vacuum assisted core biopsy (VACB) targeting the primary lesion is performed under ultrasound or stereotactic guidance. A minimum of six cores, are obtained using a 7-10 G needle. Biopsy specimens are examined by a pathologist to assess the residual tumor and tumor bed. When no tumor or atypical cells are confirmed in the valid VACB specimen, breast and axillary surgery will be omitted. Receives: Radiation: Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year EFS
5 years event-free survival after neoadjuvant chemoradiotherapy
Measured: 60 weeks
Secondary outcomes (2)
b-pCR
Whether combined neoadjuvant chemoradiotherapy can improve breast pathological complete response rate (bpCR: ypT0)
Measured: 18 weeks
OS
overall survival after completing of neoadjuvant chemoradiotherapy
Measured: 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start25 Jul 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jun 2032 (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 Tianjin Medical University Cancer Institute and 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Chemotherapy combined with radiotherapy
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital of Hainan Medical University, Shandong Cancer Hospital and Institute, First Affiliated Hospital of Kunming Medical University, Chongqing University Cancer Hospital, Tangshan People's Hospital, Taizhou Hospital
- Responsible party
- Principal investigator, Xuchen Cao, Tianjin Medical University Cancer Institute and Hospital
- Investigators
- XUCHEN CAO, MD, Principal investigator, TianJin Medical University Cancer Institute and Hospitall
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498154
- Sponsor's protocol ID
- TianJin Medical University....
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2024
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient baseline information, patient safety information
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eliminating Breast Surgery for Triple Negative or HR-/HER2+ Breast Cancer Patients With Clinical Complete Response to Combined Neoadjuvant Chemotherapy and Neoadjuvant Radiotherapy: A Multicenter, Phase 2 Trial (EBCS)
- ClinicalTrials.gov ID
- NCT06498154
- Acronym / sponsor ID
- TianJin Medical University....
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital of Hainan Medical University, Shandong Cancer Hospital and Institute, First Affiliated Hospital of Kunming Medical University, Chongqing University Cancer Hospital, Tangshan People's Hospital, Taizhou Hospital
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 12 Jul 2024 (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.
Phase II multicenter prospective study on the safety of eliminating surgery for triple negative or HER2 positive breast cancer patients with clinical response to neoadjuvant radiotherapy and neoadjuvant chemotherapy.
Detailed description
The main purpose: To explore the safety of eliminating surgery for triple negative or HER2 positive breast cancer patients with clinical response to neoadjuvant chemoradiotherapy. Secondary study objective: To explore predictive molecular biomarkers of response to neoadjuvant chemoradiotherapy and investigate whether ctDNA can predict pCR or survival outcome.
Primary endpoint: 5-year event-free survival (5-year EFS). Secondary end points: Whether combined neoadjuvant chemoradiotherapy can improve breast pathological complete response rate (bpCR: ypT0), overall survival (OS), patient-reported outcomes (PROs) and safety
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Chemotherapy combined with radiotherapy
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy | Experimental | Radiation: Neoadjuvant Chemotherapy combined with Neoadjuvant RadiotherapyPatients who meet the criteria for enrollment initially receive four cycles of TCb (HP) * neoadjuvant chemotherapy, followed by neoadjuvant radiotherapy starting from the fifth cycle of TCb (HP) * neoadjuvant chemotherapy. After completion of six cycles of neoadjuvant chemotherapy, patients underwent breast magnetic resonance imaging. When a patient meets the MRI criteria suggestive of a complete clinical response (cCR), vacuum assisted core biopsy (VACB) targeting the primary lesion is performed under ultrasound or stereotactic guidance. A minimum of six cores, are obtained using a 7-10 G needle. Biopsy specimens are examined by a pathologist to assess the residual tumor and tumor bed. When no tumor or atypical cells are confirmed in the valid VACB specimen, breast and axillary surgery will be omitted. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female initial treatment patients aged ≥ 18 years and ≤ 70 years old
- ECOG score 0-1
- Clinical T1-2N0 HER2 positive ( HR negative HER2 IHC score of 3+, or 2+and ISH test positive) or triple negative invasive breast cancer
- Left ventricular ejection fraction (LVEF) ≥ 50%
- 12 lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method for females<470ms
Key exclusion criteria (6 listed)
- Inflammatory breast cancer
- Metastatic tumor
- Previous or concurrent malignant tumors, whose natural history or treatment may interfere with the safety of the research protocol.
- Active infections that require systemic treatment
- Has used any medication in this study within 14 days prior to enrollment
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 Chemotherapy combined with Neoadjuvant RadiotherapyNeoadjuvant radiotherapy: whole-breast irradiation ( 50 Gy in 25 fractions) plus a mandatory boost (14 Gy in seven fractions, which began on the day following completion of whole-breast irradiation) TCb (HP) * : Triple negative patients will receive TCb regimens with or without immunotherapy and HER2 positive patients will receive TCb(HP) regimens. | Radiation | Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy |
Primary outcome
5-year EFS
Time frame: 60 weeks
5 years event-free survival after neoadjuvant chemoradiotherapy
2 secondary outcomes
b-pCR
Time frame: 18 weeks
OS
Time frame: 60 weeks
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 19 Dec 2025.
- Individual participant dataSharing planned: Yes. Patient baseline information, patient safety information
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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.
XUCHEN CAO, MD principal investigator
TianJin Medical University Cancer Institute and Hospitall
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy in people with Breast Cancer, run by Tianjin Medical University Cancer Institute and 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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 19 Dec 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 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.
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 ZHENGJUN YANG, MD (8613512891631, yangxinpiaoxue001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year EFS (time frame: 60 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 19 Dec 2025.