Breast CancerPhase 2UNIQUENCT05762900
Ultra-hypofractioNated Adjuvant Radiotherapy ± sImultaneous Integrated Boost for Low-risk Breast Cancer Patients
A Phase 2 study testing Ultra-fractionated radiation therapy in people with Breast Cancer and Radiotherapy Side Effect, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a phase II study to investigate the feasibility of Ultra-hypofractionated radiotherapy with or without simultaneous integrated boost for low risk breast cancer patients who have received breast conservative surgery of mastectomy. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Breast Cancer, Radiotherapy Side Effect
- What is being tested?
- Ultra-fractionated radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2022to 25 Oct 2030
- 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 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with invasive or non-invasive breast cancer;
- The patients have undergone breast-conserving surgery or mastectomy with axillary sentinel nodal biopsy or dissection;
- Stage ypT0-2N0-1 (if receive neoadjuvant therapy) or stage pT0-2N0-1 (if receive upfront surgery).
- No distant metastasis;
- Life expectancy ≥6 months;
- Organ function is fine (Hemoglobin ≥100g/L, leukocyte ≥2×109/L, neutrophil ≥1×109/L, platelet ≥80×109/L; Creatinine 1.5 mg/dl or less; Alanine aminotransferase/aspartate aminotransferase ≤2.5×UNL.);
Show all 9Show fewer
- Patients are willing to cooperate to follow up;
- Patients should sign the informed consent;
- Women of childbearing age need effective contraception.
Who cannot join
- Biopsy proven ipsilateral supraclavicular, infraclavicular or internal mammary nodal involvement.
- Concurrent or previous neuropathy overlapping with the radiation volume or brachial plexus injury;
- Patients who had radiotherapy to the ipsilateral breast, lymph-drainage regions or adjacent areas before;
- Concurrent active connective tissue disease;
- Other malignancies, which affect patient life expectancy (except adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder neoplasms (no more than T1), early stage thyroid carcinoma);
- Severe comorbidities or active disease (Poorly controlled heart disease: New York Classification of Cardiac Function ≥ Grade 2, active coronary heart disease, unstable angina pectoris, arrhythmia requiring medical treatment/persistent refractory hypertension; Myocardial infarction, stroke within six months; Poorly controlled diabetes persists. Fasting blood glucose ≥ 10mmol/L, 2 hours postprandial blood glucose ≥ 13 mmol/L. Poorly controlled psychosis develops or worsens within six months; Active infection; Positive for antibodies to HIV).
- Pregnant or breast-feeding.
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
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, 100021
Hao Jing, M.D., 8610-87788281, owletskim@163.com
About this study
Official title: Ultra-hypofractioNated Radiotherapy ± sImultaneous Integrated Boost for Low-risk(risQue) Breast Cancer Patients After Breast Conservative sUrgery or mastEctomy (UNIQUE)
This is a phase II study to investigate the feasibility of Ultra-hypofractionated radiotherapy with or without simultaneous integrated boost for low risk breast cancer patients who have received breast conservative surgery of mastectomy.
Read the detailed description
During the study, the patients would undergo radiation of 5.2Gy for 5 fractions to the prophylactic radiation volumes and and a 6Gy per-fraction simultaneous boost to the tumor bed or other high-risk volumes. Acute toxicity of grade 2 or higher in the following 12 weeks after radiotherapy is the primary end point.
- Conditions
- Breast Cancer, Radiotherapy Side Effect
- Being tested
- Ultra-fractionated radiation therapy
- Keywords
- Breast cancer, Ultra-fractionated radiotherapy, Toxicity, Lymph-drainage region irradiation
- Medical subject headings
- Breast Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-fractionated radiation therapyRadiation
Also called Simultaneous Integrated Boost
5.2Gy per fraction for 5 fractions with an integrated boost of 6Gy per fraction.
| Study group | Role | What they receive |
|---|---|---|
| Ultra-hypofractionated arm | Experimental | The patients will be treated by Ultra-hypofractionated irradiation. Receives: Radiation: Ultra-fractionated radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of patients who develop radiation-associated acute toxicity (≥ 2 degree)
The investigators will record the incidence of ≥ 2 degree radiation-associated acute toxicity, such as breast or chest wall oedema, acute dermatitis, breast pain,itch of breast skin; ≥ 3 degree radiation-associated esophagitis; ≥ 3 degree radiation-associated lymphopenia.
Measured: until 12 weeks from the completion of postoperative radiotherapy
Secondary outcomes (8)
Local recurrence rate
The incidence of recurrence of any invasive or non-invasive breast cancer in the ipsilateral breast or chest wall.
Measured: Local recurrence rate would be recorded and reported until at least 5 years after diagnosis.
Local regional recurrence rate
The incidence of recurrence in the ipsilateral breast/chest wall or the lymphatic nodal regions.
Measured: Local regional recurrence rate would be recorded and reported until at least 5 years after diagnosis.
Disease-free survival
The time interval from diagnosis to any event of recurrence or death.
Measured: Until at least 5 years after diagnosis.
Overall survival
The time interval from diagnosis to death from any reason.
Measured: Until at least 5 years after diagnosis.
The rate of patients who develop radiation-associated long-term toxicity
The investigators will record the incidence of any long-term toxicities, such as skin or subcutaneous fibrosis, pain, breast distortion, brachial plexopathy, lymphodema, cardiac event, rib fracture, pulmonary fibrosis, and so on.
Measured: From 12 weeks to 5 years post radiotherapy.
Quality of Life.
European Organization for Research and Treatment of Cancer General Quality of Life Questionnaire (brev: EORTC C-30) is used. The higher the score, the worse the situation, with the range of 28 to 112.
Measured: European Organization Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire EORTC QLQ-C30 to record patients' quality of life before and at 12, 24 and 60 months after radiotherapy.
Quality of Life.
European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (brev: EORTC BR-23) is used. The higher the score, the worse the situation, with the range of 23 to 92.
Measured: The patients' quality of life will be evaluated before and at 12, 24 and 60 months after radiotherapy.
The cosmetic outcome.
Breast Cancer Treatment Outcome Scale 22 (brev: BCTOS 22) is used, for patients who receive breast conservative surgery. The higher the score, the worse the cosmesis, with the range of 22 to 88.
Measured: The cosmetic outcome will be evaluated before and at 12, 24 and 60 months after radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start25 Oct 2022
- Primary completion25 Oct 2025 (estimated)
- Study completion25 Oct 2030 (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 Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The treatment is not a drug.
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HAO JING, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762900
- Sponsor's protocol ID
- 22/409-3611
- Acronym
- UNIQUE
- Status last verified
- Mar 2023
- First submitted
- 20 Feb 2023
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-hypofractioNated Radiotherapy ± sImultaneous Integrated Boost for Low-risk(risQue) Breast Cancer Patients After Breast Conservative sUrgery or mastEctomy (UNIQUE)
- ClinicalTrials.gov ID
- NCT05762900
- Acronym / sponsor ID
- UNIQUE / 22/409-3611
- Conditions
- Breast Cancer, Radiotherapy Side Effect
- Keywords
- Breast cancer, Ultra-fractionated radiotherapy, Toxicity, Lymph-drainage region irradiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 25 Oct 2025 (estimated)
- Study completion
- 25 Oct 2030 (estimated)
- First posted
- 10 Mar 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.
This is a phase II study to investigate the feasibility of Ultra-hypofractionated radiotherapy with or without simultaneous integrated boost for low risk breast cancer patients who have received breast conservative surgery of mastectomy.
Detailed description
During the study, the patients would undergo radiation of 5.2Gy for 5 fractions to the prophylactic radiation volumes and and a 6Gy per-fraction simultaneous boost to the tumor bed or other high-risk volumes. Acute toxicity of grade 2 or higher in the following 12 weeks after radiotherapy is the primary end point.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The treatment is not a drug.
| Arm | Type | Receives |
|---|---|---|
| Ultra-hypofractionated arm | Experimental | Radiation: Ultra-fractionated radiation therapyThe patients will be treated by Ultra-hypofractionated irradiation. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients diagnosed with invasive or non-invasive breast cancer;
- The patients have undergone breast-conserving surgery or mastectomy with axillary sentinel nodal biopsy or dissection;
- Stage ypT0-2N0-1 (if receive neoadjuvant therapy) or stage pT0-2N0-1 (if receive upfront surgery).
- No distant metastasis;
- Life expectancy ≥6 months;
Key exclusion criteria (7 listed)
- Biopsy proven ipsilateral supraclavicular, infraclavicular or internal mammary nodal involvement.
- Concurrent or previous neuropathy overlapping with the radiation volume or brachial plexus injury;
- Patients who had radiotherapy to the ipsilateral breast, lymph-drainage regions or adjacent areas before;
- Concurrent active connective tissue disease;
- Other malignancies, which affect patient life expectancy (except adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder neoplasms (no more than T1), early stage thyroid carcinoma);
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-fractionated radiation therapyAlso: Simultaneous Integrated Boost5.2Gy per fraction for 5 fractions with an integrated boost of 6Gy per fraction. | Radiation | Ultra-hypofractionated arm |
Primary outcome
The rate of patients who develop radiation-associated acute toxicity (≥ 2 degree)
Time frame: until 12 weeks from the completion of postoperative radiotherapy
The investigators will record the incidence of ≥ 2 degree radiation-associated acute toxicity, such as breast or chest wall oedema, acute dermatitis, breast pain,itch of breast skin; ≥ 3 degree radiation-associated esophagitis; ≥ 3 degree radiation-associated lymphopenia.
8 secondary outcomes
Local recurrence rate
Time frame: Local recurrence rate would be recorded and reported until at least 5 years after diagnosis.
Local regional recurrence rate
Time frame: Local regional recurrence rate would be recorded and reported until at least 5 years after diagnosis.
Disease-free survival
Time frame: Until at least 5 years after diagnosis.
Overall survival
Time frame: Until at least 5 years after diagnosis.
The rate of patients who develop radiation-associated long-term toxicity
Time frame: From 12 weeks to 5 years post radiotherapy.
Quality of Life.
Time frame: European Organization Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire EORTC QLQ-C30 to record patients' quality of life before and at 12, 24 and 60 months after radiotherapy.
Quality of Life.
Time frame: The patients' quality of life will be evaluated before and at 12, 24 and 60 months after radiotherapy.
The cosmetic outcome.
Time frame: The cosmetic outcome will be evaluated before and at 12, 24 and 60 months 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 10 Mar 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Breast Cancer
Active, not recruiting
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer
Bone Metastases, HER2-positive Breast Cancer
Active, not recruitingObservational study
A ReaL World Study of DS-8201
Breast Cancer Metastatic, Treatment Efficacy
RecruitingPhase 3
A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
Breast Neoplasms
RecruitingObservational study
Characterization of Extracellular Vesicles in Breast Cancer Patients
Breast Cancer
Not yet recruitingPhase 4
Evaluation of the Efficacy and Acceptability of a Phytotherapy Combining Devil's Claw, Blackcurrant and Meadowsweet for the Management of Aromatase Inhibitor-induced Arthralgia in Patients Treated for Localized Breast Cancer in the Adjuvant Setting
Hormone Therapy-induced Arthralgia, Phytotherapy
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 Ultra-fractionated radiation therapy in people with Breast Cancer and Radiotherapy Side Effect, run by Cancer Institute and Hospital, 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 9 inclusion and 7 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 10 Mar 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?
Contact Shu-Lian Wang, M.D. (8610-87788290, wangsl@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of patients who develop radiation-associated acute toxicity (≥ 2 degree) (time frame: until 12 weeks from the completion of postoperative 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 10 Mar 2023.