Breast CancerNCT03856372
Hypofractionated Vs Conventional Fractionated Postmastectomy Radiotherapy for High Risk Breast Cancer
A study testing Hypofractionated and Conventional in people with Breast Cancer, run by Fudan University at 3 sites in China.
Trial summary
The study was designed to investigate whether hypofractionated adjuvant radiotherapy is noninferior to conventionally fractionated adjuvant radiotherapy in terms of efficacy and toxicities for high risk breast cancer patients treated with mastectomy Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Hypofractionated and Conventional
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,494 participants
- Where
- 3 sitesChina
- Study dates
- 1 Sep 2018to 30 Aug 2022
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age18-75 years
- Pathologically confirmed invasive breast cancer
- Treated with mastectomy and axillary lymph node dissection with more than 10 resected lymph nodes. Immediate or delayed ipsilateral breast cancer reconstruction is accepted
- Negative surgical margins
- Pathologic T1-2N1 with at least one of the following risk factors: <40 years, Grade 3, lymphovascular invasion positive, ER/PR negative or HER2 overexpression, or pT3-4, or pN2-3 (four or more positive axillary lymph nodes)
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- No distant metastases
- No supraclavicular or internal mammary nodes metastases
- ECOG:0-1
- Adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-HER2 treatment is accepted.
- No neoadjuvant chemotherapy
- Fit for postoperative radiotherapy. No contraindications to radiotherapy
- Signed informed consent
Who cannot join
- Concurrent or previous malignancy excluding basal or squamous cell carcinoma of the skin
- Previous radiotherapy to the chest wall or regional lymph node areas
- Patients with severe non-malignant comorbidity in cardiovascular or respiration system
- Patients with medical contraindication for radiotherapy: systemic lupus erythematosus, cirrhosis
- pT1-2N1 with none of the following risk factors: <40 years, Grade 3, lymphovascular invasion positive, ER/PR negative or HER2 overexpression
- Patients with supraclavicular or internal mammary nodes metastases
Show all 13Show fewer
- Known definitive clinical or radiologic evidence of metastatic disease
- Bilateral breast cancer or historically confirmed contralateral invasive breast cancer
- Treated with neoadjuvant chemotherapy
- ECOG: 3-4
- Pregnant or lactating
- Conditions indicating that the patient cannot go through the radiation therapy or follow up
- Unable or unwilling to sign informed consent
Trial locations and contacts
3 sites in 1 country.
China3 sites
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Huangpu Branch, Shanghai ninth people's hospital
Shanghai, Shanghai Municipality
Suzhou Municipal hospital
Suzhou, Jiangsu
About this study
Official title: Postmastectomy Hypofractionated Versus Conventional Fractionated Radiotherapy in High Risk Breast Cancer: a Phase III Randomized Clinical Trial
The study was designed to investigate whether hypofractionated adjuvant radiotherapy is noninferior to conventionally fractionated adjuvant radiotherapy in terms of efficacy and toxicities for high risk breast cancer patients treated with mastectomy
Read the detailed description
The randomization is between 50 Gy / 25 fractions and 42.5 Gy/16 fractions, 5 fractions weekly.
Eligible breast cancer patients with mastectomy and axillary dissection will be randomized 1:1 into two groups: conventional fractionated (CF) radiotherapy of 50 Gy / 25 fractions and hypofractionated (HF) radiotherapy of 42.5 Gy/16 fractions, 5 fractions weekly.
The primary endpoint is loco-regional recurrence. Other cancer related events and acute/late radiation morbidities will also be evaluated. The patients will be followed for 10 years.
It is hypothesized that for women operated for high risk breast cancer with indication of postmastectomy adjuvant radiotherapy, hypofractionated radiotherapy is noninferior to conventional fractionated radiotherapy in terms of the efficacy and toxicities.
- Conditions
- Breast Cancer
- Being tested
- Hypofractionated, Conventional
- Keywords
- Postmastectomy Hypofractionated Adjuvant 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.
HypofractionatedRadiation
Also called Experimental Arm
daily fractions, five fractions per week.
ConventionalRadiation
Also called Standard Arm
daily fractions, five fractions per week.
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated | Experimental | 42.5 Gy / 16 fractions, 2.66 Gy per fraction, 5 fractions weekly Receives: Radiation: Hypofractionated |
| Conventional | Active comparator | 50 Gy / 25 fractions, 2.00 Gy per fraction, 5 fractions weekly Receives: Radiation: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loco-regional recurrence (LRR)
Defined as any clinical and biopsy-proven tumor recurrence involving the ipsilateral chest wall and/or regional nodes (including axillary, supraclavicular, infraclavicular, or internal mammary nodes). Time to loco-regional recurrence is defined as the interval starting from the date of randomization until the event. LRR will be assessed every 3 months during the first 2 years after the last fraction received, every 6 months during the following 3-5 years and every year thereafter through 10 years
Measured: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
Secondary outcomes (14)
Distant metastasis free survival (DMFS)
Distant metastasis is defined as clinical detection of metastatic disease beyond the chest wall and/or regional lymph nodes or death or last visit. Distant metastasis free survival (DMFS) is defined as the interval starting from the date of randomization until to the event. Distant metastasis will be assessed every 3 months during the first 2 years after the last fraction received, every 6 months during the following 3-5 years and every year thereafter through 10 years.
Measured: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
Disease free survival (DFS)
Defined as the interval from the date of randomization to any disease recurrence or death or last visit. It will be assessed every 3 months during the first 2 years after the last fraction received, every 6 months during the following 3-5 years and every year thereafter through 10 years
Measured: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
Overall survival (OS)
Defined as the interval from the date of randomization to death or last visit. It will be assessed every 3 months during the first 2 years after the last fraction received, every 6 months during the following 3-5 years and every year thereafter through 10 years
Measured: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
CTCAE Toxicity Assessment-Acute toxicity
Acute toxicity (development of radiation dermatitis, pruritus, pain, radiation esophagitis, and radiation pneumonitis) will be assessed according to toxicity criteria of CTCAE version 4.03 before treatment, every week of treatment, the end of treatment, 2 weeks, 3 months after the last fraction received and every year thereafter through 10 years
Measured: before treatment, every week of treatment, the end of treatment, 2 weeks, 3 months after the last fraction received, every year through 10 years
CTCAE Toxicity Assessment-Late toxicity
Late toxicity (development of sclerosis in irradiated area and ischemic heart disease) will be assessed according to toxicity criteria of CTCAE version 4.03 before treatment and every year through 10 years following the completion of radiotherapy
Measured: before treatment, every year after the last fraction received through 10 years
LENT-SOMA Toxicity Assessment
Development of dyspigmentation, telangiectasia in irradiated area and radiation pulmonary fibrosis will be assessed according to toxicity criteria of LENT-SOMA before treatment and every year through 10 years following the completion of radiotherapy
Measured: before treatment, every year after the last fraction received through 10 years
Number of patients with Arm Lymphedema
Arm lymphedema defined as ≥10% increase in the treated arm circumference over baseline circumference compared to the contralateral arm. Arm circumference 15 cm above the medial epicondyle (upper arms) and 15 cm below the medial epicondyle (lower arms) will be measured before treatment and every year through 10 years following the completion of radiotherapy at every time point
Measured: before treatment, every year after the last fraction received through 10 years
Number of patients with impaired shoulder movement (Range of motion of the shoulders)
Impaired shoulder movement is present when >20 degrees difference between arms at flexion and/or Abduction. Shoulder movement (Range of motion of the shoulders) will be assessed before treatment and every year through 10 years following the completion of radiotherapy
Measured: before treatment, every year after the last fraction received through 10 years
Number of patients with symptomatic rib fracture
Symptomatic rib fracture will be diagnosed by evidence of a correlative lesion on plain film or CT. It will be assessed before treatment and every year through 10 years following the completion of radiotherapy
Measured: before treatment, every year after the last fraction received through 10 years
Number of patients with brachial plexopathy
Brachial plexopathy will be documented if damage to the brachial plexus is suspected and patients have symptoms of pain, paresthesia, numbness, or other symptoms. Suspected cases of brachial plexopathy will be subject to confirmation by neurophysiological assessment. Brachial plexopathy will be assessed before treatment and every year through 10 years following the completion of radiotherapy
Measured: before treatment, every year after the last fraction received through 10 years
Number of patients with reconstruction complications
For patients received mastectomy and reconstruction, the following complications will be assessed before treatment and every year through 10 years following the completion of radiotherapy: capsular contraction, partial or entire flap necrosis or loss, implant leakage and rupture, implant exposure, infection, hematoma/seroma and secondary surgical intervention
Measured: before treatment, every year after the last fraction received through 10 years
Cosmetic outcomes for patients received mastectomy with reconstruction
The cosmetic outcomes will be evaluated by radiation oncologists, nurses and patients using digital photographs and Harvard/NSABP/RTOG Breast Cosmesis Grading Scale. Harvard/NSABP/RTOG Breast Cosmesis Grading Scale classifies the overall aesthetic results in four categories from excellent, good, fair to poor; comparing the reconstructed breast to the control breast. Excellent, there is minimal or no difference in the size or shape of the treated breast; good, slight difference in the size or shape of the treated breast; fair, obvious difference in the size or shape of the treated breast; and poor, marked change in the size or shape of the treated breast. The cosmetic outcomes will be assessed before treatment and every year through 10 years following the completion of radiotherapy. The breast cosmetic outcome will be measured by Harvard 4 scale (poor, fair, good, excellent) evaluation system
Measured: before treatment, every year after the last fraction received through 10 years
Quality of Life Life-EORTC QLQ-C30 (version 3)
Patients' quality of life will be assessed using self-administered questionnaire EORTC-QLQ-C30 (version 3) before treatment, the end of treatment, and every year through 10 years following the completion of radiotherapy
Measured: before treatment, the end of treatment, every year after the last fraction received through 10 years
Quality of Life-EORTC breast-cancer module (BR23)
Patients' quality of life will be assessed using self-administered questionnaire EORTC breast-cancer module (BR23) before treatment, the end of treatment, and every year through 10 years following the completion of radiotherapy
Measured: before treatment, the end of treatment, every year after the last fraction received through 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start1 Sep 2018
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 1,494 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinli Ma, Fudan University
- Investigators
- Jinli Ma, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856372
- Sponsor's protocol ID
- FDRT-BC008
- Status last verified
- Feb 2019
- First submitted
- 20 Feb 2019
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang X, Zhang X, Chen X, Yang Z, Mei X, Zhang L, Meng J, Shi W, Luo J, Jin K, Gu Y, Mo M, Zhang Z, Yu K, Liu G, Wu J, Shao Z, Guo X, Yu X, Ma J. Hypofractionated Versus Conventionally Fractionated Postmastectomy Radiotherapy With Internal Mammary Node Irradiation for High-Risk Breast Cancer (HypoMast-IMNI): A Randomized Phase III Trial. J Clin Oncol. 2026 Oct 19:JCO2502843. doi: 10.1200/JCO-25-02843. Online ahead of print.
PubMed 42896129
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postmastectomy Hypofractionated Versus Conventional Fractionated Radiotherapy in High Risk Breast Cancer: a Phase III Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03856372
- Acronym / sponsor ID
- FDRT-BC008
- Conditions
- Breast Cancer
- Keywords
- Postmastectomy Hypofractionated Adjuvant Radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,494 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 27 Feb 2019 (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.
The study was designed to investigate whether hypofractionated adjuvant radiotherapy is noninferior to conventionally fractionated adjuvant radiotherapy in terms of efficacy and toxicities for high risk breast cancer patients treated with mastectomy
Detailed description
The randomization is between 50 Gy / 25 fractions and 42.5 Gy/16 fractions, 5 fractions weekly.
Eligible breast cancer patients with mastectomy and axillary dissection will be randomized 1:1 into two groups: conventional fractionated (CF) radiotherapy of 50 Gy / 25 fractions and hypofractionated (HF) radiotherapy of 42.5 Gy/16 fractions, 5 fractions weekly.
The primary endpoint is loco-regional recurrence. Other cancer related events and acute/late radiation morbidities will also be evaluated. The patients will be followed for 10 years.
It is hypothesized that for women operated for high risk breast cancer with indication of postmastectomy adjuvant radiotherapy, hypofractionated radiotherapy is noninferior to conventional fractionated radiotherapy in terms of the efficacy and toxicities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated | Experimental | Radiation: Hypofractionated42.5 Gy / 16 fractions, 2.66 Gy per fraction, 5 fractions weekly |
| Conventional | Active comparator | Radiation: Conventional50 Gy / 25 fractions, 2.00 Gy per fraction, 5 fractions weekly |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Female
- Age18-75 years
- Pathologically confirmed invasive breast cancer
- Treated with mastectomy and axillary lymph node dissection with more than 10 resected lymph nodes. Immediate or delayed ipsilateral breast cancer reconstruction is accepted
- Negative surgical margins
Key exclusion criteria (13 listed)
- Concurrent or previous malignancy excluding basal or squamous cell carcinoma of the skin
- Previous radiotherapy to the chest wall or regional lymph node areas
- Patients with severe non-malignant comorbidity in cardiovascular or respiration system
- Patients with medical contraindication for radiotherapy: systemic lupus erythematosus, cirrhosis
- pT1-2N1 with none of the following risk factors: <40 years, Grade 3, lymphovascular invasion positive, ER/PR negative or HER2 overexpression
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 |
|---|---|---|
| HypofractionatedAlso: Experimental Armdaily fractions, five fractions per week. | Radiation | Hypofractionated |
| ConventionalAlso: Standard Armdaily fractions, five fractions per week. | Radiation | Conventional |
Primary outcome
Loco-regional recurrence (LRR)
Time frame: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
Defined as any clinical and biopsy-proven tumor recurrence involving the ipsilateral chest wall and/or regional nodes (including axillary, supraclavicular, infraclavicular, or internal mammary nodes). Time to loco-regional recurrence is defined as the interval starting from the date of randomization until the event. LRR will be assessed every 3 months during the first 2 years after the last fraction received, every 6 months during the following 3-5 years and every year thereafter through 10 years
14 secondary outcomes
Distant metastasis free survival (DMFS)
Time frame: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
Disease free survival (DFS)
Time frame: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
Overall survival (OS)
Time frame: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
CTCAE Toxicity Assessment-Acute toxicity
Time frame: before treatment, every week of treatment, the end of treatment, 2 weeks, 3 months after the last fraction received, every year through 10 years
CTCAE Toxicity Assessment-Late toxicity
Time frame: before treatment, every year after the last fraction received through 10 years
LENT-SOMA Toxicity Assessment
Time frame: before treatment, every year after the last fraction received through 10 years
Number of patients with Arm Lymphedema
Time frame: before treatment, every year after the last fraction received through 10 years
Number of patients with impaired shoulder movement (Range of motion of the shoulders)
Time frame: before treatment, every year after the last fraction received through 10 years
Number of patients with symptomatic rib fracture
Time frame: before treatment, every year after the last fraction received through 10 years
Number of patients with brachial plexopathy
Time frame: before treatment, every year after the last fraction received through 10 years
Number of patients with reconstruction complications
Time frame: before treatment, every year after the last fraction received through 10 years
Cosmetic outcomes for patients received mastectomy with reconstruction
Time frame: before treatment, every year after the last fraction received through 10 years
Quality of Life Life-EORTC QLQ-C30 (version 3)
Time frame: before treatment, the end of treatment, every year after the last fraction received through 10 years
Quality of Life-EORTC breast-cancer module (BR23)
Time frame: before treatment, the end of treatment, every year after the last fraction received through 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Derived from this study: PubMed 42896129Wang X, Zhang X, Chen X, Yang Z, Mei X, Zhang L, Meng J, Shi W, Luo J, Jin K, Gu Y, Mo M, Zhang Z, Yu K, Liu G, Wu J, Shao Z, Guo X, Yu X, Ma J. Hypofractionated Versus Conventionally Fractionated Postmastectomy Radiotherapy With Internal Mammary Node Irradiation for High-Risk Breast Cancer (HypoMast-IMNI): A Randomized Phase III Trial. J Clin Oncol. 2026 Oct 19:JCO2502843. doi: 10.1200/JCO-25-02843. Online ahead of print.
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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.
Jinli Ma, MD, PhD principal investigator
Fudan University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated and Conventional in people with Breast Cancer, run by Fudan University at 3 sites 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 13 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: finished, as of the sponsor's last update on 3 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 3 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Loco-regional recurrence (LRR) (time frame: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03856372, which also lists 1 linked publication.
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 3 Sep 2026.