Breast CancerPhase 2NCT05692674
A Prospective Phase II Study for Adjuvant Hypofractionated Intensity-modulated Proton Radiotherapy for Post Operative Breast Cancer With Implantation Reconstruction
A Phase 2 study testing adjuvant hypofractionated intensity-modulated proton radiotherapy in people with Breast Cancer, run by Shanghai Proton and Heavy Ion Center at 1 site in China.
Trial summary
The incidence of breast reconstruction failure after conventional photon radiotherapy for breast cancer is about 18.7%. At present, there is limited data on proton radiotherapy for post operative breast cancer with implantation reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- adjuvant hypofractionated intensity-modulated proton radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2023to 1 Sep 2028
- Phase
- Phase 2
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1: Patients with pathologically confirmed breast cancer
- 2: Indications: patients who need adjuvant radiotherapy after mastectomy and implant reconstruction
- 3: No distant metastasis
- 4: Had no chest and breast radiotherapy history
- 5: Between the ages of 18 and 80
- 6: ECOG general status score is 0-2,There are no serious pulmonary hypertension, cardiovascular disease, peripheral vascular disease, serious chronic heart disease and other complications that may affect the radiotherapy
- 7: Non pregnancy (confirmed by serum or urine β- HCG test) or lactating women
- 8: The patient must sign the informed consent form for receiving radiotherapy.
Who cannot join
- 1: No pathological confirmation；
- 2: Distant metastasis；
- 3: Had chest and breast radiotherapy history
- 4: Organs at risk could not achieve safe dose
- 5: Pregnancy (confirmed by serum or urine β- HCG test) or lactating women
- 6: Poor general health status, i.e. KPS<70, or ECOG>2
- 7: There are serious complications that may affect the radiotherapy, including: a) unstable angina, congestive heart failure and myocardial infarction requiring hospitalization in the past 6 months； b) Acute bacterial or systemic fungal infection；c) Chronic obstructive pulmonary disease exacerbation or other respiratory diseases need hospitalization； d) Patients with immunosuppression；e) With connective tissue disease, such as active scleroderma or lupus and other contraindications to radiotherapy；
- 8: Unable to understand the purpose of treatment or unwilling/unable to sign informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Proton and Heavy Ion center
Shanghai, Shanghai Municipality, 201321
Ping Li, +86 021-38296666, ping.li@sphic.org.cn
Cihang Bao, +86 021-38296666, cihang.Bao@sphic.org.cn
About this study
The incidence of breast reconstruction failure after conventional photon radiotherapy for breast cancer is about 18.7%. At present, there is limited data on proton radiotherapy for post operative breast cancer with implantation reconstruction. Proton radiotherapy for breast cancer can significantly reduce the radiation dose of the ipsilateral heart and lung, thereby reducing the incidence of cardiac events and radiation pneumonia. This study is aimed at the study of adjuvant hypofractionated intensity-modulated proton radiotherapy for post operative breast cancer with implantation reconstruction. It can provide an ideal treatment option for such patients to effectively protect the heart and lungs without increasing the failure rate of breast reconstruction after adjuvant radiotherapy.
- Conditions
- Breast Cancer
- Being tested
- adjuvant hypofractionated intensity-modulated proton radiotherapy
- Keywords
- breast cancer, hypofractionated, proton radiotherapy, implantation reconstruction, postoperative 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.
adjuvant hypofractionated intensity-modulated proton radiotherapyRadiation
CTV1: chest wall ± regional lymph drainage area, 40.05Gy (RBE) in 15 fractions with proton radiotherapy;
| Study group | Role | What they receive |
|---|---|---|
| adjuvant hypofractionated intensity-modulated proton radiotherapy | Experimental | CTV1: chest wall ± regional lymph drainage area, proton therapy. Receives: Radiation: adjuvant hypofractionated intensity-modulated proton radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the failure rate of breast reconstruction after hypofractionated proton radiotherapy
Reoperation
Measured: within 2 years after hypofractionated proton radiotherapy
Secondary outcomes (2)
Acute and late toxicities
Treatment related toxicity assessed by CTCAE v4.03
Measured: within 5 years after radiotherapy
Tumor local control rate, overall survival rate and progression free survival rate
The Ipsilateral breast and regional lymph nodes recurrence, death and progression
Measured: within 5 years after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start10 Jan 2023 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Proton and Heavy Ion Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing Zhang,MD, Shanghai Proton and Heavy Ion Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692674
- Sponsor's protocol ID
- SPHIC-TR-BCa2022-02
- Status last verified
- Jan 2023
- First submitted
- 11 Jan 2023
- Last updated
- 20 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Study for Adjuvant Hypofractionated Intensity-modulated Proton Radiotherapy for Post Operative Breast Cancer With Implantation Reconstruction
- ClinicalTrials.gov ID
- NCT05692674
- Acronym / sponsor ID
- SPHIC-TR-BCa2022-02
- Conditions
- Breast Cancer
- Keywords
- breast cancer, hypofractionated, proton radiotherapy, implantation reconstruction, postoperative adjuvant radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Shanghai Proton and Heavy Ion CenterUniversity, hospital or other
- Study start
- 10 Jan 2023 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 20 Jan 2023 (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 incidence of breast reconstruction failure after conventional photon radiotherapy for breast cancer is about 18.7%. At present, there is limited data on proton radiotherapy for post operative breast cancer with implantation reconstruction. Proton radiotherapy for breast cancer can significantly reduce the radiation dose of the ipsilateral heart and lung, thereby reducing the incidence of cardiac events and radiation pneumonia. This study is aimed at the study of adjuvant hypofractionated intensity-modulated proton radiotherapy for post operative breast cancer with implantation reconstruction. It can provide an ideal treatment option for such patients to effectively protect the heart and lungs without increasing the failure rate of breast reconstruction after adjuvant radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adjuvant hypofractionated intensity-modulated proton radiotherapy | Experimental | Radiation: adjuvant hypofractionated intensity-modulated proton radiotherapyCTV1: chest wall ± regional lymph drainage area, proton therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1: Patients with pathologically confirmed breast cancer
- 2: Indications: patients who need adjuvant radiotherapy after mastectomy and implant reconstruction
- 3: No distant metastasis
- 4: Had no chest and breast radiotherapy history
- 5: Between the ages of 18 and 80
Key exclusion criteria (8 listed)
- 1: No pathological confirmation；
- 2: Distant metastasis；
- 3: Had chest and breast radiotherapy history
- 4: Organs at risk could not achieve safe dose
- 5: Pregnancy (confirmed by serum or urine β- HCG test) or lactating women
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 |
|---|---|---|
| adjuvant hypofractionated intensity-modulated proton radiotherapyCTV1: chest wall ± regional lymph drainage area, 40.05Gy (RBE) in 15 fractions with proton radiotherapy; | Radiation | adjuvant hypofractionated intensity-modulated proton radiotherapy |
Primary outcome
the failure rate of breast reconstruction after hypofractionated proton radiotherapy
Time frame: within 2 years after hypofractionated proton radiotherapy
Reoperation
2 secondary outcomes
Acute and late toxicities
Time frame: within 5 years after radiotherapy
Tumor local control rate, overall survival rate and progression free survival rate
Time frame: within 5 years after radiotherapy
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 20 Jan 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing adjuvant hypofractionated intensity-modulated proton radiotherapy in people with Breast Cancer, run by Shanghai Proton and Heavy Ion Center 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 8 inclusion and 8 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 20 Jan 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the failure rate of breast reconstruction after hypofractionated proton radiotherapy (time frame: within 2 years after hypofractionated proton radiotherapy). 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 20 Jan 2023.