Breast CancerNCT07672743
A Phase II Study of Radiation Therapy to Treat Refractory Breast Cancer
A study testing Radical dose radiotherapy in people with Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
For locally advanced or recurrent metastatic breast cancer that is resistant to systemic therapy, radiotherapy (RT) may be considered as the preferred treatment option when the lesion is unresectable, or the patient is not suitable for surgery. 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?
- Radical dose radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2026to 31 Dec 2027
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Locally advanced or recurrent metastatic breast cancer, pathologically confirmed;
- At least one extracranial measurable lesion suitable for radiotherapy;
- Signature of informed consent form.
Who cannot join
- Pregnant or lactation women;
- Severe concomitant conditions, including persistent or active infections, symptomatic congestive heart failure, unstable angina pectoris, and serious arrhythmias et al.
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
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Shu-Lian Wang, MD., +86-010-87787659, wangsl@cicams.ac.cn
About this study
Official title: A Prospective Phase II Study of Radiation Therapy to Treat Refractory Breast Cancer
For locally advanced or recurrent metastatic breast cancer that is resistant to systemic therapy, radiotherapy (RT) may be considered as the preferred treatment option when the lesion is unresectable, or the patient is not suitable for surgery. This study aim to evelatuate the local control of radical dose RT or new RT technique (such as patially fractionated radiation therapy, SFRT) for the locally advanced or recurrent metastatic breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Radical dose radiotherapy
- Keywords
- breast cancer, radiotherapy, spatially fractionated 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.
Radical dose radiotherapyRadiation
Radical dose is delivered for the patients. SFRT is recommended for the patients with bulky tumor (such as ≥ 5cm). SFRT is delivered with 12-20Gy (1 fraction) followed by external beam radiation therapy (EBRT) with EQD2≥60Gy.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Experimental | Radical dose is delivered for the patients. . SFRT is recommended for the patients with bulky tumor (such as ≥ 5cm). SFRT is delivered with 12-20Gy (1 fraction) followed by EBRT with EQD2≥60Gy. Receives: Radiation: Radical dose radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Measured: 3 months
Secondary outcomes (5)
Overall Response Rate (ORR)
Measured: 1 month
Local control
Measured: 1 year
Progression-Free Survival (PFS)
Measured: 1 year
Overall Survival (OS)
Measured: 1 year
Number of participants with treatment-related acute and late adverse events as assessed by CTCAE v5.0
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shulian Wang,MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672743
- Sponsor's protocol ID
- NCC5020
- Status last verified
- Jan 2026
- First submitted
- 25 Jan 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Study of Radiation Therapy to Treat Refractory Breast Cancer
- ClinicalTrials.gov ID
- NCT07672743
- Acronym / sponsor ID
- NCC5020
- Conditions
- Breast Cancer
- Keywords
- breast cancer, radiotherapy, spatially fractionated radiation therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Jun 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 locally advanced or recurrent metastatic breast cancer that is resistant to systemic therapy, radiotherapy (RT) may be considered as the preferred treatment option when the lesion is unresectable, or the patient is not suitable for surgery. This study aim to evelatuate the local control of radical dose RT or new RT technique (such as patially fractionated radiation therapy, SFRT) for the locally advanced or recurrent metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Experimental | Radiation: Radical dose radiotherapyRadical dose is delivered for the patients. . SFRT is recommended for the patients with bulky tumor (such as ≥ 5cm). SFRT is delivered with 12-20Gy (1 fraction) followed by EBRT with EQD2≥60Gy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Locally advanced or recurrent metastatic breast cancer, pathologically confirmed;
- At least one extracranial measurable lesion suitable for radiotherapy;
- Signature of informed consent form.
Key exclusion criteria (2 listed)
- Pregnant or lactation women;
- Severe concomitant conditions, including persistent or active infections, symptomatic congestive heart failure, unstable angina pectoris, and serious arrhythmias et al.
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 |
|---|---|---|
| Radical dose radiotherapyRadical dose is delivered for the patients. SFRT is recommended for the patients with bulky tumor (such as ≥ 5cm). SFRT is delivered with 12-20Gy (1 fraction) followed by external beam radiation therapy (EBRT) with EQD2≥60Gy. | Radiation | Radiotherapy |
Primary outcome
Overall Response Rate (ORR)
Time frame: 3 months
5 secondary outcomes
Overall Response Rate (ORR)
Time frame: 1 month
Local control
Time frame: 1 year
Progression-Free Survival (PFS)
Time frame: 1 year
Overall Survival (OS)
Time frame: 1 year
Number of participants with treatment-related acute and late adverse events as assessed by CTCAE v5.0
Time frame: 1 year
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 29 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radical dose radiotherapy in people with Breast Cancer, 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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 29 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?
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?
Overall Response Rate (ORR) (time frame: 3 months). 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 29 Jun 2026.