An interventional study of standard boost and boost omission in Breast Cancer, sponsored by Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Fudan University · Not applicable, Interventional, and Treatment
Among 260 studies in Breast Neoplasms by Fudan University — 122 open to participants now, 142 under way, 31 of them phase 3. Breast Neoplasms · Fudan University.
Among the 260 studies in Breast Neoplasms by Fudan University, this one is the 44th largest by planned enrollment of the 199 interventional ones that give a count, is one of 36 that started in 2026, is one of 35 with no phase, reaches primary completion later than 125 of the 141 other live ones, and was the 254th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
Browse Breast Neoplasms studies →122 of the 260 studies in Breast Neoplasms by Fudan University are open now, in 1 country. Recruiting first, the newest first:
Fudan University · Sites in China
Ages 18–75 · Women only
Fudan University · Sites in China
Ages 18+ · Women only
Fudan University · Sites in China
Ages 18+
Fudan University · Sites in China
Ages 18+
Fudan University · Sites in China
Ages 18–75 · Women only
By country, each count listing its studies:
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
260 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 110 · Phase 3 51 · Phase 4 5
First in 2003; this study’s year is marked. 36 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 534 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Median enrollment 170 across the 199 interventional studies, 179 across the 60 observational. Of the 64 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Fudan University is the lead sponsor of 1,316 studies on the registry; 644 are open to participants now.
19 of the studies in Breast Neoplasms by Fudan University that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06447623Phase 3Fudan UniversityApatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer | 2027-02-01 |
| NCT06341621Phase 3Fudan UniversityChemotherapy Omission in ER+/HER2- Breast Cancer With 1-3 Positive Lymph Nodes Receiving Extended Adjuvant Abemaciclib | 2027-02-25 |
| NCT06966141Fudan UniversityA Real World Study of Sacituzumab Govitecan | 2026-12-01 |
| NCT06331169Fudan UniversityAnlotinib With Trastuzumab Deruxtecan for Previously Treated HER2-Low Advanced Breast Cancer | 2026-12-31 |
| NCT06798506Fudan UniversityReal-world Patient-reported Outcome of Sacituzumab Govitecan in Chinese Metastatic Triple-negative Breast Cancer | 2027-01-15 |
Add all 19 to your calendar (.ics) → With an account.
Among the 260 studies in Breast Neoplasms by Fudan University, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Background Clinical N3 (cN3) breast cancer represents a high-risk subgroup of locally advanced disease. After neoadjuvant systemic therapy (NST), patients who achieve a clinical complete response (cCR) in initially involved but undissected nodal stations currently receive a boost to these regions as part of standard postoperative radiotherapy. However, whether this boost is necessary in this setting remains unknown, and prospective evidence on the safety of boost omission is lacking.
Objective The REACT-N3 trial aims to evaluate whether omitting the boost to undissected nodal stations that achieve cCR after NST is non-inferior to standard boost in terms of 3-year invasive breast cancer recurrence-free interval (IBCRFI), while reducing toxicity to adjacent organs.
Methods This is an open-label, multicenter, randomized phase 3 trial. Eligible patients are women with cN3 breast cancer who have completed 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-NST [¹⁸F]FDG PET-CT or other imaging. Participants will be randomized 1:1 to receive either a standard boost (10 Gy in 5 fractions) or no boost to the initially involved but cCR-converted undissected nodal stations. Randomization is stratified by postoperative axillary nodal status (ypN- vs. ypN+), location of the involved nodal station (SCV vs. non-SCV), and molecular subtype (TNBC vs. non-TNBC). The primary endpoint is 3-year IBCRFI. Secondary endpoints include locoregional recurrence-free survival, distant metastasis-free survival, disease-free survival, overall survival, toxicity, and patient-reported outcomes. With a non-inferiority margin of 8%, a one-sided α of 0.05, 80% power, and 10% drop-out rate, a total of 534 patients will be enrolled.
Discussion The REACT-N3 trial will provide high-level evidence on the safety of boost omission in cN3 breast cancer patients with cCR 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
cN3b: metastasis to ipsilateral IMNs with concurrent level I/II ALN involvement.
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 (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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
a standard boost of 10Gy was delivered to the initially involved but undissected nodal stations that achieved clinical complete response
Radiation: standard boost
no boost was given to the initially involved but undissected nodal stations that achieved clinical complete response after neoadjuvant systemic therapy
Radiation: boost omission
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
no boost to the initially involved but undissected nodal stations that achieved clinical complete response after neoadjuvant systemic therapy
3-year invasive breast cancer (IBC) recurrence-free interval (RFI)
Time frame: 3-year
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Sep 2030, 48 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 48 months is above that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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