Breast CancerHARVEST-PRONCT07527689
Ultra-Hypofractionated vs Moderate Hypofractionated Radiotherapy for Regional Lymph Nodes in High Risk Breast Cancer
A study testing Ultra-hypofractionated Regional Nodal Irradiation and Moderate Hypofractionated Regional Nodal Irradiation in people with Breast Cancer, run by Ruijin Hospital at 1 site in China.
Trial summary
For patients with breast cancer, regional nodal irradiation (RNI) can significantly reduce the risks of recurrence and mortality. Moderate hypofractionated regimens (40 to 42.5 Gy in 15 to 16 fractions over 3 weeks) is the established standard of care for RNI. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ultra-hypofractionated Regional Nodal Irradiation and Moderate Hypofractionated Regional Nodal Irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,950 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2026to 30 Mar 2039
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide a signed and dated informed consent form (ICF) before the initiation of any trial-specific procedures.
- Age ≥ 18 years.
- Histologically confirmed invasive breast cancer.
- Have received breast-conserving surgery or mastectomy with axillary staging, including sentinel lymph node biopsy, targeted axillary dissection and/or axillary lymph node dissection.
- Tumor stage is classified as T1, T2, or T3, as defined by the AJCC Cancer Staging Manual, 8th Edition.
- Meeting at least one of the following conditions:
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- Pathological nodal status of pN2 or pN3a;
- Pathological nodal status of pN1 with one or more of the following high-risk factors:
- (I), Age < 40 years. (II), Tumor location in the central or inner quadrant. (III), Estrogen Receptor (ER) negative. (IV), Presence of lymphovascular invasion (LVI). (V), Histological grade III. (VI), Patients presenting with clinical stage cN2-3a before neoadjuvant treatment.
- Pathologically negative surgical margins, defined as "no ink on tumor."
- Karnofsky Performance Status (KPS) score ≥ 80.
- Documented biomarker status for Estrogen Receptor (ER), Progesterone Receptor (PR), HER2, and Ki-67.
- Sufficient wound healing from surgery, with no signs of active infection at the intended radiation site.
Who cannot join
- Nodal stage is classified as N3b or N3c, as defined by the AJCC Cancer Staging Manual, 8th Edition.
- Has undergone or is planning immediate breast reconstruction with a permanent implant or tissue expander.
- Evidence of distant metastatic disease.
- Diagnosis of synchronous bilateral invasive breast cancer or a history of prior invasive cancer in either breast.
- History of prior radiation therapy to the chest, axillary, or supraclavicular regions.
- Known active collagen vascular diseases, particularly systemic lupus erythematosus or scleroderma, which are contraindications to radiotherapy.
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- Presence of any severe, uncontrolled co-morbidity or medical condition that, in the investigator's judgment, would render the participant unsuitable for the study, compromise protocol compliance, or confound the interpretation of study results.
- History of any other malignancy within the 5 years before enrollment, with the exception of adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix.
- Participants who are pregnant or lactating at the time of study enrollment. (Note: In accordance with the standards of each participating institution, women of childbearing age are required to undergo pregnancy testing within 2 weeks prior to randomization.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jia-Yi Chen, PhD, MD contact
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
Jia-Yi Chen, PhD, MD, +86 021-64370045, chenjiayi0188@aliyun.com
About this study
Official title: A Multicenter, Randomized, Controlled Phase III Clinical Trial Comparing Ultra-Hypofractionated Versus Moderate Hypofractionated Radiotherapy for Regional Lymph Nodes in Post-operative Breast Cancer
For patients with breast cancer, regional nodal irradiation (RNI) can significantly reduce the risks of recurrence and mortality. Moderate hypofractionated regimens (40 to 42.5 Gy in 15 to 16 fractions over 3 weeks) is the established standard of care for RNI. Nevertheless, for the majority of patients, a three - week treatment duration is still regarded as lengthy. Although the ultra-hypofractionated regimen (26 Gy in 5 fractions over 1 week) has been proven non-inferior to the moderate hypofractionated regimen for whole breast irradiation, unambiguous evidence supporting its use in comprehensive RNI remains lacking, especially in high risk patients requiring internal mammary node irradiation (IMNI). This prospective, non-inferiority trial is designed to address this evidence gap by evaluating whether a one-week, ultra-hypofractionated regimen (26 Gy in 5 fractions) is non-inferior to the three-week regimen (40 Gy in 15 fractions) for comprehensive RNI, including IMNI.
Read the detailed description
The study intervention is RNI delivered using modern techniques, including Intensity-Modulated Radiation Therapy (IMRT), Volumetric Modulated Arc Therapy (VMAT) or Intensity-Modulated Proton Therapy (IMPT). Technical parameters for treatment delivery, such as target delineation and OARs dose constraints, will be standardized across both arms. The investigational component is the randomized comparison of the ultra-hypofractionated regimen (26 Gy in 5 fractions over one week) and the moderate hypofractionated regimen (40 Gy in 15 fractions over three weeks).
- Conditions
- Breast Cancer
- Being tested
- Ultra-hypofractionated Regional Nodal Irradiation, Moderate Hypofractionated Regional Nodal Irradiation
- Keywords
- Adjuvant Radiotherapy, regional nodal irradiation, internal mammary node irradiation, ultrahypofractionated radiation therapy, hypofractionated radiation 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.
Ultra-hypofractionated Regional Nodal IrradiationRadiation
Also called 5-fraction Regional Nodal Irradiation, Ultra-hypofractionated RNI
26 Gy in 5 fractions over 1 week (5.2 Gy per fraction, once daily). Treatment targets include ipsilateral supraclavicular, infraclavicular, internal mammary regions, chest wall or whole breast, and any portion of the undissected axilla at risk. Sequential tumor bed boost of 10.4 Gy in 2 fractions (5.2 Gy per fraction) for patients after breast-conserving surgery.
Moderate Hypofractionated Regional Nodal IrradiationRadiation
Also called Moderate hypofractionated RNI, 15-fraction Regional Nodal Irradiation
40.05 Gy in 15 fractions over 3 weeks (2.67 Gy per fraction, once daily). Treatment targets include ipsilateral supraclavicular, infraclavicular, internal mammary regions, chest wall or whole breast, and any portion of the undissected axilla at risk. Simultaneous Integrated Boost of 48 Gy in 15 fractions (3.2 Gy per fraction) for patients after breast-conserving surgery.
| Study group | Role | What they receive |
|---|---|---|
| Ultra-hypofractionated regimen | Experimental | Participants will receive ultra-hypofractionated radiotherapy to regional lymph nodes and chest wall/whole breast. For patients after breast-conserving surgery, a sequential boost to the tumor bed will be administered. Systemic therapy (chemotherapy, endocrine therapy, or targeted therapy) will be given according to standard clinical practice. Receives: Radiation: Ultra-hypofractionated Regional Nodal Irradiation |
| Moderate hypofractionated regimen | Active comparator | Participants will receive moderate hypofractionated radiotherapy to regional lymph nodes and chest wall/whole breast. For patients after breast-conserving surgery, a simultaneous integrated boost to the tumor bed will be administered. Systemic therapy (chemotherapy, endocrine therapy, or targeted therapy) will be given according to standard clinical practice. Receives: Radiation: Moderate Hypofractionated Regional Nodal Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive Breast Cancer Recurrence-Free Survival (IBC-RFS)
IBC-RFS, defined as time from randomization until any first invasive ipsilateral breast, chest wall, regional, or distant recurrence, or death from breast cancer. Data for patients who are alive and free of an event at the time of final analysis or are lost to follow-up will be censored at the date of last contact.
Measured: 5 years
Secondary outcomes (6)
Acute Radiation-Induced Toxicity
Incidence of any grade 1 or higher acute radiation-induced toxicity occurring from the start of radiotherapy through 90 days after completion of radiotherapy, graded per CTCAE v5.0, RTOG Acute Radiation Morbidity Scoring Criteria and LENT/SOMA Scoring Scale.
Measured: From start of radiotherapy through 90 days after completion of radiotherapy
Late Radiation-Induced Toxicity
Incidence of any grade 1 or higher radiation-induced toxicity event occurring >90 days after radiotherapy completion, graded using CTCAE v5.0, RTOG/EORTC Late Radiation Morbidity Scoring Schema, and LENT/SOMA Scoring Scale
Measured: From 90 days after completion of radiotherapy to 10 years
Overall Survival (OS)
Time from randomization to death from any cause.
Measured: 10 years
Locoregional Recurrence-Free Survival (LRRFS)
Time from randomization to the first ipsilateral breast, chest wall, or regional nodal recurrence.
Measured: 10 years
Distant Metastasis-Free Survival (DMFS)
Time from randomization to the first evidence of distant metastasis.
Measured: 10 years
Disease-Free Survival (DFS)
Time from randomization to first occurrence of ipsilateral breast cancer recurrence (invasive or DCIS), locoregional recurrence (chest wall or regional lymph nodes), distant metastasis, contralateral invasive breast cancer, or death from any cause.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start22 Apr 2026
- Primary completion30 Mar 2034 (estimated)
- Study completion30 Mar 2039 (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 Ruijin 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
- Parallel groups
- Model description
- Upon confirmation of eligibility and after obtaining informed consent, participants will be randomly assigned in a 1:1 ratio to either Arm A (Ultra-Hypofractionated regimen) or Arm B (Moderate hypofractionated regimen). To ensure a balance of key prognostic factors, randomization will be performed using a stratified block design, with stratification by pathologic nodal status (pN1 vs. pN2-3), and participating centers.
- Masking
- None (open label)
- Enrolment
- 1,950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JIAYI CHEN, Ruijin Hospital
- Investigators
- Jia-Yi Chen, PhD, MD, Principal investigator, Department of Radiation Oncology, Ruijin Hospital, Shanghai Jiao Tong University School of MedicineLu Cao, PhD, MD, Principal investigator, Department of Radiation Oncology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527689
- Sponsor's protocol ID
- RJIBC-ULTRA RNI
- Acronym
- HARVEST-PRO
- Status last verified
- Jun 2026
- First submitted
- 1 Apr 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the publication, after deidentification (text, tables, figures, and appendices), will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Phase III Clinical Trial Comparing Ultra-Hypofractionated Versus Moderate Hypofractionated Radiotherapy for Regional Lymph Nodes in Post-operative Breast Cancer
- ClinicalTrials.gov ID
- NCT07527689
- Acronym / sponsor ID
- HARVEST-PRO / RJIBC-ULTRA RNI
- Conditions
- Breast Cancer
- Keywords
- Adjuvant Radiotherapy, regional nodal irradiation, internal mammary node irradiation, ultrahypofractionated radiation therapy, hypofractionated radiation therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,950 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- 30 Mar 2034 (estimated)
- Study completion
- 30 Mar 2039 (estimated)
- First posted
- 14 Apr 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.
For patients with breast cancer, regional nodal irradiation (RNI) can significantly reduce the risks of recurrence and mortality. Moderate hypofractionated regimens (40 to 42.5 Gy in 15 to 16 fractions over 3 weeks) is the established standard of care for RNI. Nevertheless, for the majority of patients, a three - week treatment duration is still regarded as lengthy. Although the ultra-hypofractionated regimen (26 Gy in 5 fractions over 1 week) has been proven non-inferior to the moderate hypofractionated regimen for whole breast irradiation, unambiguous evidence supporting its use in comprehensive RNI remains lacking, especially in high risk patients requiring internal mammary node irradiation (IMNI). This prospective, non-inferiority trial is designed to address this evidence gap by evaluating whether a one-week, ultra-hypofractionated regimen (26 Gy in 5 fractions) is non-inferior to the three-week regimen (40 Gy in 15 fractions) for comprehensive RNI, including IMNI.
Detailed description
The study intervention is RNI delivered using modern techniques, including Intensity-Modulated Radiation Therapy (IMRT), Volumetric Modulated Arc Therapy (VMAT) or Intensity-Modulated Proton Therapy (IMPT). Technical parameters for treatment delivery, such as target delineation and OARs dose constraints, will be standardized across both arms. The investigational component is the randomized comparison of the ultra-hypofractionated regimen (26 Gy in 5 fractions over one week) and the moderate hypofractionated regimen (40 Gy in 15 fractions over three weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Upon confirmation of eligibility and after obtaining informed consent, participants will be randomly assigned in a 1:1 ratio to either Arm A (Ultra-Hypofractionated regimen) or Arm B (Moderate hypofractionated regimen). To ensure a balance of key prognostic factors, randomization will be performed using a stratified block design, with stratification by pathologic nodal status (pN1 vs. pN2-3), and participating centers.
| Arm | Type | Receives |
|---|---|---|
| Ultra-hypofractionated regimen | Experimental | Radiation: Ultra-hypofractionated Regional Nodal IrradiationParticipants will receive ultra-hypofractionated radiotherapy to regional lymph nodes and chest wall/whole breast. For patients after breast-conserving surgery, a sequential boost to the tumor bed will be administered. Systemic therapy (chemotherapy, endocrine therapy, or targeted therapy) will be given according to standard clinical practice. |
| Moderate hypofractionated regimen | Active comparator | Radiation: Moderate Hypofractionated Regional Nodal IrradiationParticipants will receive moderate hypofractionated radiotherapy to regional lymph nodes and chest wall/whole breast. For patients after breast-conserving surgery, a simultaneous integrated boost to the tumor bed will be administered. Systemic therapy (chemotherapy, endocrine therapy, or targeted therapy) will be given according to standard clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Provide a signed and dated informed consent form (ICF) before the initiation of any trial-specific procedures.
- Age ≥ 18 years.
- Histologically confirmed invasive breast cancer.
- Have received breast-conserving surgery or mastectomy with axillary staging, including sentinel lymph node biopsy, targeted axillary dissection and/or axillary lymph node dissection.
- Tumor stage is classified as T1, T2, or T3, as defined by the AJCC Cancer Staging Manual, 8th Edition.
Key exclusion criteria (9 listed)
- Nodal stage is classified as N3b or N3c, as defined by the AJCC Cancer Staging Manual, 8th Edition.
- Has undergone or is planning immediate breast reconstruction with a permanent implant or tissue expander.
- Evidence of distant metastatic disease.
- Diagnosis of synchronous bilateral invasive breast cancer or a history of prior invasive cancer in either breast.
- History of prior radiation therapy to the chest, axillary, or supraclavicular regions.
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 |
|---|---|---|
| Ultra-hypofractionated Regional Nodal IrradiationAlso: 5-fraction Regional Nodal Irradiation, Ultra-hypofractionated RNI26 Gy in 5 fractions over 1 week (5.2 Gy per fraction, once daily). Treatment targets include ipsilateral supraclavicular, infraclavicular, internal mammary regions, chest wall or whole breast, and any portion of the undissected axilla at risk. Sequential tumor bed boost of 10.4 Gy in 2 fractions (5.2 Gy per fraction) for patients after breast-conserving surgery. | Radiation | Ultra-hypofractionated regimen |
| Moderate Hypofractionated Regional Nodal IrradiationAlso: Moderate hypofractionated RNI, 15-fraction Regional Nodal Irradiation40.05 Gy in 15 fractions over 3 weeks (2.67 Gy per fraction, once daily). Treatment targets include ipsilateral supraclavicular, infraclavicular, internal mammary regions, chest wall or whole breast, and any portion of the undissected axilla at risk. Simultaneous Integrated Boost of 48 Gy in 15 fractions (3.2 Gy per fraction) for patients after breast-conserving surgery. | Radiation | Moderate hypofractionated regimen |
Primary outcome
Invasive Breast Cancer Recurrence-Free Survival (IBC-RFS)
Time frame: 5 years
IBC-RFS, defined as time from randomization until any first invasive ipsilateral breast, chest wall, regional, or distant recurrence, or death from breast cancer. Data for patients who are alive and free of an event at the time of final analysis or are lost to follow-up will be censored at the date of last contact.
6 secondary outcomes
Acute Radiation-Induced Toxicity
Time frame: From start of radiotherapy through 90 days after completion of radiotherapy
Late Radiation-Induced Toxicity
Time frame: From 90 days after completion of radiotherapy to 10 years
Overall Survival (OS)
Time frame: 10 years
Locoregional Recurrence-Free Survival (LRRFS)
Time frame: 10 years
Distant Metastasis-Free Survival (DMFS)
Time frame: 10 years
Disease-Free Survival (DFS)
Time frame: 10 years
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 30 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the publication, after deidentification (text, tables, figures, and appendices), will be shared.
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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.
Jia-Yi Chen, PhD, MD contact
Jia-Yi Chen, PhD, MD principal investigator
Department of Radiation Oncology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lu Cao, PhD, MD principal investigator
Department of Radiation Oncology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra-hypofractionated Regional Nodal Irradiation and Moderate Hypofractionated Regional Nodal Irradiation in people with Breast Cancer, run by Ruijin 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 13 inclusion and 9 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 30 Jun 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?
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 Lu Cao, PhD, MD (+86 147824551281, cl11879@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive Breast Cancer Recurrence-Free Survival (IBC-RFS) (time frame: 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 30 Jun 2026.