Breast CancerNCT07805538
Response-Adapted Omission of Nodal Boost In N3 Breast Cancer After Neoadjuvant Therapy
A study testing Standard Boost. and Boost Omission in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This is an open-label, multicenter, randomized phase 3 trial. Eligible patients are women with cN3 breast cancer who have completed neoadjuvant systemic therapy (NST), undergone breast/axillary surgery with the internal mammary, supraclavicular, and infraclavicular nodes left undissected, and have no macroscopic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Standard Boost. and Boost Omission
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 1 Sep 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female/male, aged 18-75 years.
- ECOG performance status 0-1.
- Histologically confirmed unilateral invasive breast cancer.
- No DM (M0), as confirmed by standard staging.
- cN3 disease, defined according to AJCC 8th staging system, confirmed by imaging and/or pathology, including any of the following: cN3a: metastasis to ipsilateral ICV nodes, with or without level I/II ALN involvement.
- cN3b: metastasis to ipsilateral IMNs with concurrent level I/II ALN involvement.
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- cN3c: metastasis to ipsilateral SCV nodes, with or without ALN or IMN involvement.
- Imaging confirmation is mandatory for all cN3 designations and may be performed using ultrasound, contrast-enhanced CT, MRI, or [18F]FDG PET-CT [16-18]. Across all modalities, abnormal features include, but are not limited to: abnormal enlargement (short-axis ≥5mm), rounded morphology with loss of the normal oval shape, solid appearance with effacement of the fatty hilum and cortical thickening, with or without irregular margins or necrosis. Modality-specific criteria include: heterogeneous enhancement on CT or MRI, or increased FDG uptake (SUVmax > mediastinal blood pool) on PET-CT. Pathological verification by fine-needle aspiration (FNA) or core needle biopsy (CNB) is recommended for SCV and ICV nodes when clinically feasible. If pathological confirmation is not obtained, the cN3 status is based solely on imaging criteria specified above.
- Completion of NST. Standard-of-care regimens must include at least four cycles of chemotherapy; Anti-HER2 targeted therapy is mandatory for HER2-positive disease, and immunotherapy may be added for eligible triple-negative breast cancer (TNBC). Clinical trial regimens are permitted per protocol, with or without chemotherapy, including novel agents (e.g., antibody-drug conjugates [ADCs], immunotherapies, anti-angiogenics, PARP inhibitors, or other investigational drugs). Both pathways are accepted provided the full protocol-specified course is completed.
- Underwent breast-conserving surgery (BCS) or mastectomy with levels I-II axillary lymph node dissection (ALND); IMN, SCV, and ICV nodes were left undissected. All surgical margins must be negative.
- Post-neoadjuvant imaging confirms no macroscopic residual disease in the initially involved but undissected nodal stations. The preferred modality is [18F]FDG PET-CT; ultrasound, contrast-enhanced CT or MRI are acceptable alternatives if PET-CT is unavailable. Imaging may be performed before or after surgery, but must be completed prior to randomization. For all modalities, cCR is defined as the complete disappearance of all previously involved but undissected lymph nodes. In cases where visible nodes persist on imaging, cCR may still be considered if: on PET-CT, no pathologic uptake; on ultrasound, CT, or MRI, nodes have normalized in size and morphology, and no suspicious features are present. Suspicious or equivocal findings require biopsy confirmation of negativity before randomization. All imaging studies must be interpreted by experienced radiologists using standardized criteria.
- Radiotherapy must start within 12 weeks of last surgery or last adjuvant chemotherapy cycle.
- Adjuvant systemic therapy per guidelines or trial protocols; investigational regimens require active trial enrollment.
- Written informed consent obtained.
Who cannot join
- Stage IV (metastatic) breast cancer.
- Prior or synchronous contralateral breast cancer.
- Macroscopic residual disease in the initially involved but undissected nodal stations (ICV, IMN, or SCV) in cN3 patients, as evidenced by post-neoadjuvant imaging and/or biopsy.
- Incomplete NST or no definitive breast/ALN surgery.
- Prior radiotherapy to the breast, CW, or regional nodes.
- History of other malignancies, except for adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ (disease-free >3 years).
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- Current pregnancy or lactation.
- Severe uncontrolled comorbidities (e.g., cardiac, hepatic, renal, or infectious) precluding radiotherapy, as judged by the investigator.
- Known intolerance or contraindication to radiotherapy or to the planned adjuvant systemic therapy (chemotherapy, endocrine therapy, anti HER2 therapy, or immunotherapy).
- Inability or unwillingness to comply with protocol requirements.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Omitting the Boost to Initially Involved But Undissected Nodal Stations That Achieved Clinical Complete Response After Neoadjuvant Systemic Therapy in cN3 Breast Cancer: a Multicenter, Prospective, Phase III Randomized Study
This is an open-label, multicenter, randomized phase 3 trial. Eligible patients are women with cN3 breast cancer who have completed neoadjuvant systemic therapy (NST), undergone breast/axillary surgery with the internal mammary, supraclavicular, and infraclavicular nodes left undissected, and have no macroscopic residual disease in these stations on post-NAT [¹⁸F]FDG PET-CT or other imagings. The primary endpoint is 3-year invasive breast cancer recurrence-free interval (IBCRFI). Secondary endpoints include locoregional recurrence-free survival, distant metastasis-free survival, disease-free survival, overall survival, toxicity, and patient reported outcomes. This trial will provide high-level evidence on the safety of nodal boost omission in cN3 breast cancer patients with clinical complete response after NST. If non-inferiority is confirmed, this strategy could establish a new, toxicity-sparing standard for regional nodal irradiation in this high-risk population.
- Conditions
- Breast Cancer
- Being tested
- Standard Boost., Boost Omission
- Keywords
- clinical N3 breast cancer, neoadjuvant systemic therapy, clinical complete response, regional nodal irradiation, boost omission
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Boost.Radiation
a boost dose of 10 Gy in 5 fractions to initially involved but undissected nodal stations that achieved clincial complete response after neoadjuvant systemic therapy
Boost OmissionRadiation
no boost to the initially involved but undissected nodal stations that achieved clinical complete response after neoadjuvant systemic therapy
| Study group | Role | What they receive |
|---|---|---|
| standard boost | Active comparator | a standard boost of 10Gy was delivered to the initially involved but undissected nodal stations that achieved clinical complete response Receives: Radiation: Standard Boost. |
| boost omission | Experimental | no boost was given to the initially involved but undissected nodal stations that achieved clinical complete response after neoadjuvant systemic therapy Receives: Radiation: Boost Omission |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year Invasive Breast Cancer Recurrence-Free Interval (IBCRFI)
IBCRFI is defined as the time from randomization to the first occurrence of ipsilateral invasive breast cancer (IBC) recurrence (breast, chest wall [CW], or regional nodes), distant metastasis (DM), or breast cancer death.
Measured: IBCRFI is defined as the time from randomization to the first occurrence of ipsilateral invasive breast cancer (IBC) recurrence (breast, chest wall [CW], or regional nodes), distant metastasis (DM), or breast cancer death.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Sep 2026
- Primary completion1 Sep 2026
- Study completion1 Sep 2026
Why it stopped: funding issues and poor accrual
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 Fudan UniversityThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinli Ma, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805538
- Sponsor's protocol ID
- FDRT-BC025
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omitting the Boost to Initially Involved But Undissected Nodal Stations That Achieved Clinical Complete Response After Neoadjuvant Systemic Therapy in cN3 Breast Cancer: a Multicenter, Prospective, Phase III Randomized Study
- ClinicalTrials.gov ID
- NCT07805538
- Acronym / sponsor ID
- FDRT-BC025
- Conditions
- Breast Cancer
- Keywords
- clinical N3 breast cancer, neoadjuvant systemic therapy, clinical complete response, regional nodal irradiation, boost omission
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding issues and poor accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 4 Sep 2026 (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.
This is an open-label, multicenter, randomized phase 3 trial. Eligible patients are women with cN3 breast cancer who have completed neoadjuvant systemic therapy (NST), undergone breast/axillary surgery with the internal mammary, supraclavicular, and infraclavicular nodes left undissected, and have no macroscopic residual disease in these stations on post-NAT [¹⁸F]FDG PET-CT or other imagings. The primary endpoint is 3-year invasive breast cancer recurrence-free interval (IBCRFI). Secondary endpoints include locoregional recurrence-free survival, distant metastasis-free survival, disease-free survival, overall survival, toxicity, and patient reported outcomes. This trial will provide high-level evidence on the safety of nodal boost omission in cN3 breast cancer patients with clinical complete response after NST. If non-inferiority is confirmed, this strategy could establish a new, toxicity-sparing standard for regional nodal irradiation in this high-risk population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard boost | Active comparator | Radiation: Standard Boost.a standard boost of 10Gy was delivered to the initially involved but undissected nodal stations that achieved clinical complete response |
| boost omission | Experimental | Radiation: Boost Omissionno boost was given to the initially involved but undissected nodal stations that achieved clinical complete response after neoadjuvant systemic therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Female/male, aged 18-75 years.
- ECOG performance status 0-1.
- Histologically confirmed unilateral invasive breast cancer.
- No DM (M0), as confirmed by standard staging.
- cN3 disease, defined according to AJCC 8th staging system, confirmed by imaging and/or pathology, including any of the following: cN3a: metastasis to ipsilateral ICV nodes, with or without level I/II ALN involvement.
Key exclusion criteria (10 listed)
- Stage IV (metastatic) breast cancer.
- Prior or synchronous contralateral breast cancer.
- Macroscopic residual disease in the initially involved but undissected nodal stations (ICV, IMN, or SCV) in cN3 patients, as evidenced by post-neoadjuvant imaging and/or biopsy.
- Incomplete NST or no definitive breast/ALN surgery.
- Prior radiotherapy to the breast, CW, or regional nodes.
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 |
|---|---|---|
| Standard Boost.a boost dose of 10 Gy in 5 fractions to initially involved but undissected nodal stations that achieved clincial complete response after neoadjuvant systemic therapy | Radiation | standard boost |
| Boost Omissionno boost to the initially involved but undissected nodal stations that achieved clinical complete response after neoadjuvant systemic therapy | Radiation | boost omission |
Primary outcome
3-year Invasive Breast Cancer Recurrence-Free Interval (IBCRFI)
Time frame: IBCRFI is defined as the time from randomization to the first occurrence of ipsilateral invasive breast cancer (IBC) recurrence (breast, chest wall [CW], or regional nodes), distant metastasis (DM), or breast cancer death.
IBCRFI is defined as the time from randomization to the first occurrence of ipsilateral invasive breast cancer (IBC) recurrence (breast, chest wall [CW], or regional nodes), distant metastasis (DM), or breast cancer death.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Boost. and Boost Omission in people with Breast Cancer, run by Fudan University 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 14 inclusion and 10 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: withdrawn, as of the sponsor's last update on 15 Sep 2026. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year Invasive Breast Cancer Recurrence-Free Interval (IBCRFI) (time frame: IBCRFI is defined as the time from randomization to the first occurrence of ipsilateral invasive breast cancer (IBC) recurrence (breast, chest wall [CW], or regional nodes), distant metastasis (DM), or breast cancer death.). 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 15 Sep 2026.