Breast CancerPhase 3NCT00793962
A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-risk Breast Cancer
A Phase 3 study testing hypofractionation radiotherapy and conventional fractionation radiotherapy in people with Breast Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to compare the efficacy and toxicities of hypofractionation radiotherapy with conventional fractionation radiotherapy in breast cancer patients treated with mastectomy.It is hypothesized that the efficacy and toxicities are similar between the two groups. 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?
- hypofractionation radiotherapy and conventional fractionation radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 810 participants
- Where
- 1 siteChina
- Study dates
- Jun 2008to Sep 2018
- Phase
- Phase 3
- 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
- Ipsilateral histologically confirmed invasive breast cancer
- Undergone total mastectomy and axillary dissection
- T3-4,or >=4 positive axillary lymph nodes
- Fit for chemotherapy(if indicated),endocrine therapy(if indicated)and postoperative irradiation
- Written,informed consent
- cT3-4,or cN2, or pathological positive axillary lymph nodes during mastectomy for patients who had received neoadjuvant chemotherapy or hormone therapy
Show all 10Show fewer
- no supraclavicular or internal mammary nodes metastases
- no distant metastases
- enrollment date no more than 8 months after surgery or no more than 2 months after chemotherapy for patients who didn't receive neoadjuvant systemic therapy.
- enrollment date no more than 2 months after surgery for patients who had received neoadjuvant systemic therapy and didn't need adjuvant chemotherapy.
Who cannot join
- Patients who undergone previous irradiation to the ipsilateral chest wall and supraclavicular region
- Previous or concurrent malignant other than non-melanomatous skin cancer
- Unable or unwilling to give informed consent
- bilateral breast cancer
- immediate or delayed ipsilateral breast cancer reconstruction
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
About this study
The purpose of this study is to compare the efficacy and toxicities of hypofractionation radiotherapy with conventional fractionation radiotherapy in breast cancer patients treated with mastectomy.It is hypothesized that the efficacy and toxicities are similar between the two groups.
Read the detailed description
Eligible breast cancer patients with mastectomy and axillary dissection are randomized into 2 groups:conventional fractionation radiotherapy of 50 Gy in 25 fractions within 5 weeks to ipsilateral chest wall and supraclavicular nodal region,and hypofractionation radiotherapy of 43.5Gy in 15 fractions within 3 weeks to the same region.
During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.
- Conditions
- Breast Cancer
- Being tested
- hypofractionation radiotherapy, conventional fractionation radiotherapy
- Keywords
- breast cancer, mastectomy, radiotherapy, fractionation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypofractionation radiotherapyRadiation
Also called radiotherapy
radiotherapy of 43.5Gy/15f/3w to the chest wall and supraclavicular nodal region
conventional fractionation radiotherapyRadiation
Also called radiotherapy
50Gy/25/f/5w
| Study group | Role | What they receive |
|---|---|---|
| hypofractionation radiotherapy | Experimental | breast cancer women with mastectomy high-risk: T3-4 and/or 4 or more axillary nodes involvement postmastectomy hypofractionation radiotherapy of 43.5Gy/15f/3w to the chest wall and supraclavicular nodal region Receives: Radiation: hypofractionation radiotherapy |
| conventional fractionation radiotherapy | Active comparator | breast cancer women with mastectomy high-risk with T3-4 and/or 4 or more axillary nodes postmastectomy conventional fractionation radiotherapy of 50Gy/25f/5w to the chest wall and supraclavicular nodal region Receives: Radiation: conventional fractionation radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
locoregional control rate
ipsilateral chest wall, axilla, supraclavicular and internal mammary nodal relapse
Measured: 5 years
Secondary outcomes (1)
overall survival
any death
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startJun 2008
- Primary completionMay 2016
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 810 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu lian Wang, Chinese Academy of Medical Sciences
- Investigators
- shu-lian wang, M.D., Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical SciencesYe-xiong Li, M.D., Study chair, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793962
- Sponsor's protocol ID
- LC2008A06
- Status last verified
- Oct 2018
- First submitted
- 17 Nov 2008
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sun GY, Chen SY, Tang Y, Fang H, Song YW, Liu YP, Jin J, Li N, Lu NN, Tang Y, Qi SN, Chen B, Jing H, Zhai YR, Zhang WW, Liu X, Yang ZB, Zhao XR, Song YC, Wang DQ, Wang SJ, Qiu ZH, Zhang CN, Yang SJ, Zhu JR, Liu JR, Shen XW, Hu C, Li YX, Wang SL. Hypofractionated versus conventional fractionated postmastectomy radiotherapy for patients with high-risk breast cancer (CHN HYPOPMRT): 10-year outcomes from a randomised, non-inferiority, open-label, phase 3 trial. Lancet Oncol. 2026 Oct;27(10):1249-1259. doi: 10.1016/S1470-2045(26)00297-4.
PubMed 42805199Yang J, Qi SN, Fang H, Song YW, Jin J, Liu YP, Wang WH, Yang Y, Tang Y, Ren H, Chen B, Lu NN, Tang Y, Li N, Jing H, Wang SL, Li YX. Cost-effectiveness of postmastectomy hypofractionated radiation therapy vs conventional fractionated radiation therapy for high-risk breast cancer. Breast. 2021 Aug;58:72-79. doi: 10.1016/j.breast.2021.04.002. Epub 2021 Apr 19.
PubMed 33933925Wang SL, Fang H, Song YW, Wang WH, Hu C, Liu YP, Jin J, Liu XF, Yu ZH, Ren H, Li N, Lu NN, Tang Y, Tang Y, Qi SN, Sun GY, Peng R, Li S, Chen B, Yang Y, Li YX. Hypofractionated versus conventional fractionated postmastectomy radiotherapy for patients with high-risk breast cancer: a randomised, non-inferiority, open-label, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):352-360. doi: 10.1016/S1470-2045(18)30813-1. Epub 2019 Jan 30.
PubMed 30711522
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-risk Breast Cancer
- ClinicalTrials.gov ID
- NCT00793962
- Acronym / sponsor ID
- LC2008A06
- Conditions
- Breast Cancer
- Keywords
- breast cancer, mastectomy, radiotherapy, fractionation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 810 participants (actual)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- May 2016 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 19 Nov 2008 (estimated)
- 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 purpose of this study is to compare the efficacy and toxicities of hypofractionation radiotherapy with conventional fractionation radiotherapy in breast cancer patients treated with mastectomy.It is hypothesized that the efficacy and toxicities are similar between the two groups.
Detailed description
Eligible breast cancer patients with mastectomy and axillary dissection are randomized into 2 groups:conventional fractionation radiotherapy of 50 Gy in 25 fractions within 5 weeks to ipsilateral chest wall and supraclavicular nodal region,and hypofractionation radiotherapy of 43.5Gy in 15 fractions within 3 weeks to the same region.
During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypofractionation radiotherapy | Experimental | Radiation: hypofractionation radiotherapybreast cancer women with mastectomy high-risk: T3-4 and/or 4 or more axillary nodes involvement postmastectomy hypofractionation radiotherapy of 43.5Gy/15f/3w to the chest wall and supraclavicular nodal region |
| conventional fractionation radiotherapy | Active comparator | Radiation: conventional fractionation radiotherapybreast cancer women with mastectomy high-risk with T3-4 and/or 4 or more axillary nodes postmastectomy conventional fractionation radiotherapy of 50Gy/25f/5w to the chest wall and supraclavicular nodal region |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Ipsilateral histologically confirmed invasive breast cancer
- Undergone total mastectomy and axillary dissection
- T3-4,or >=4 positive axillary lymph nodes
- Fit for chemotherapy(if indicated),endocrine therapy(if indicated)and postoperative irradiation
- Written,informed consent
Key exclusion criteria (5 listed)
- Patients who undergone previous irradiation to the ipsilateral chest wall and supraclavicular region
- Previous or concurrent malignant other than non-melanomatous skin cancer
- Unable or unwilling to give informed consent
- bilateral breast cancer
- immediate or delayed ipsilateral breast cancer reconstruction
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 |
|---|---|---|
| hypofractionation radiotherapyAlso: radiotherapyradiotherapy of 43.5Gy/15f/3w to the chest wall and supraclavicular nodal region | Radiation | hypofractionation radiotherapy |
| conventional fractionation radiotherapyAlso: radiotherapy50Gy/25/f/5w | Radiation | conventional fractionation radiotherapy |
Primary outcome
locoregional control rate
Time frame: 5 years
ipsilateral chest wall, axilla, supraclavicular and internal mammary nodal relapse
1 secondary outcome
overall survival
Time frame: 5 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 11 Oct 2018.
- Derived from this study: PubMed 42805199Sun GY, Chen SY, Tang Y, Fang H, Song YW, Liu YP, Jin J, Li N, Lu NN, Tang Y, Qi SN, Chen B, Jing H, Zhai YR, Zhang WW, Liu X, Yang ZB, Zhao XR, Song YC, Wang DQ, Wang SJ, Qiu ZH, Zhang CN, Yang SJ, Zhu JR, Liu JR, Shen XW, Hu C, Li YX, Wang SL. Hypofractionated versus conventional fractionated postmastectomy radiotherapy for patients with high-risk breast cancer (CHN HYPOPMRT): 10-year outcomes from a randomised, non-inferiority, open-label, phase 3 trial. Lancet Oncol. 2026 Oct;27(10):1249-1259. doi: 10.1016/S1470-2045(26)00297-4.
- Derived from this study: PubMed 33933925Yang J, Qi SN, Fang H, Song YW, Jin J, Liu YP, Wang WH, Yang Y, Tang Y, Ren H, Chen B, Lu NN, Tang Y, Li N, Jing H, Wang SL, Li YX. Cost-effectiveness of postmastectomy hypofractionated radiation therapy vs conventional fractionated radiation therapy for high-risk breast cancer. Breast. 2021 Aug;58:72-79. doi: 10.1016/j.breast.2021.04.002. Epub 2021 Apr 19.
- Derived from this study: PubMed 30711522Wang SL, Fang H, Song YW, Wang WH, Hu C, Liu YP, Jin J, Liu XF, Yu ZH, Ren H, Li N, Lu NN, Tang Y, Tang Y, Qi SN, Sun GY, Peng R, Li S, Chen B, Yang Y, Li YX. Hypofractionated versus conventional fractionated postmastectomy radiotherapy for patients with high-risk breast cancer: a randomised, non-inferiority, open-label, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):352-360. doi: 10.1016/S1470-2045(18)30813-1. Epub 2019 Jan 30.
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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.
shu-lian wang, M.D. principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Ye-xiong Li, M.D. study chair
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing hypofractionation radiotherapy and conventional fractionation radiotherapy in people with Breast Cancer, run by Chinese Academy of Medical Sciences 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 10 inclusion and 5 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 11 Oct 2018. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
locoregional control rate (time frame: 5 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 NCT00793962, which also lists 3 linked publications.
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 11 Oct 2018.