Breast Cancer MetastaticPhase 3NCT04646564
Radiotherapy for Extracranial Oligometastatic Breast Cancer
A Phase 3 study of Breast Cancer Metastatic, run by Chinese Academy of Medical Sciences at 2 sites in China.
Trial summary
More and more evidence suggests that local radiotherapy can improve the outcomes for patients with oligometastatic disease. The purpose of this study is to assess the impact of radiotherapy, compared with standard systemic therapy alone, on survival, local control and toxicities in patients with extracranial… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer Metastatic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 2 sitesChina
- Study dates
- 6 Apr 2021to 30 Apr 2026
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years old
- ECOG performance status 0-2.
- Newly-diagnosed or metachronous extracranial oligometastatic diseases confirmed by pathology or imaging, with or without locoregional disease (biopsy of metastasis is preferred).
- Total number of locoregional and metastatic lesions of 1-5 , the maximum diameter of lesions ≤5 cm and at least one lesion could be evaluated by RECIST1.1.
- Have received or plan to receive systemic therapy.
- All lesions could be safely treated by radiotherapy.
- Life expectancy > 6 months.
- Have adequate organ function.
Who cannot join
- Have metastases in the central nervous system.
- have indications for palliative radiotherapy to reduce symptoms, such as pain, bleeding, obstruction, and pending fractures caused by the tumor.
- Have moderate/severe liver dysfunction (Child Pugh B or C) from liver metastases, .
- Malignant pleural effusion
- Unable to tolerate radiotherapy due to serious comorbidity
- Have received prior radiotherapy for target area
- Pregnant or lactating women
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Shu-lian Wang, M.D, 8610-87788803, wangsl@cicams.ac.cn
- Recruiting
Wei-Fang Yang
Taizhou, Zhejiang
Wei-Fang Yang, M.D.
About this study
Official title: Systemic Therapy With or Without Local Radiotherapy for Extracranial Oligometastatic Breast Cancer
More and more evidence suggests that local radiotherapy can improve the outcomes for patients with oligometastatic disease. The purpose of this study is to assess the impact of radiotherapy, compared with standard systemic therapy alone, on survival, local control and toxicities in patients with extracranial oligometastatic breast cancer. Eligible patients are randomized in a 1:2 ratio between the control arm (standard systemic therapy), and the WLRT arm (standard systemic therapy + radiotherapy). Randomization will be stratified by three factors: visceral metastasis (yes vs.no), number of metastases(≤2 vs. >2), hormone receptor(positive vs. negative). SBRT technique is preferred. During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.
- Conditions
- Breast Cancer Metastatic
- Being tested
- standard of care, radiotherapy + standard of care
- Keywords
- breast neoplasm, oligometastases, radiotherapy, stereotactic ablative 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.
standard of careDrug
patients receive appropriate therapy at the discretion of the treating oncologist, i.e. systemic therapy according to molecular subtypes, including chemotherapy, endocrine therapy, targeted therapy, or immunotherapy.
radiotherapy + standard of careRadiation
Patients receive radiotherapy to all known metastases. SBRT technique is preferred, especially for metastases in bone, lung and liver. Conventional RT can be used when SBRT is not appropriate, such as metastasis in mediastinal or contralateral supraclavicular nodal regions. Total doses of 30Gy to 50Gy in 5 fractions for SBRT are recommended depending on the tolerance of adjacent normal tissue. Total dose of 60Gy in 25 fractions is recommended for conventional RT.
Patients can receive systemic therapy concurrently with RT at the discretion of treating radiation oncologist. After completion of SBRT to all sites of known metastatic disease, patients will continue standard of care therapy per the treating oncologist.
| Study group | Role | What they receive |
|---|---|---|
| control arm | Active comparator | standard of care Receives: Drug: standard of care |
| study arm | Experimental | radiotherapy + standard of care Receives: Drug: standard of care; Radiation: radiotherapy + standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Time from randomization to disease progression at any site or death.
Measured: 2 years
Secondary outcomes (6)
Overall Survival
Time from randomization to death from any cause.
Measured: 2 years
Local control rate
Incidence of tumor control within RT fields during follow up.
Measured: 2 years
Incidence of toxicities
Incidence of acute and late toxicities from treatment graded according to radiation therapy oncology group (RTOG) radiation injury criteria and National Cancer Institute CTCAE version 4.0
Measured: 2 years
Quality of Life measured by the Functional Assessment of Cancer Therapy- General (FACT-G)
Assessment of quality of life scores by FACT-G
Measured: 2 years
Translational exploration
Assessment of circulating tumor cells (CTCs), ctDNA, as prognostic and predictive markers of survival, and for early detection of progression.
Measured: 2 years
Proportion of acceptable SBRT completion
Proportion of patients who completed SBRT with acceptable dose prescriptions
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start6 Apr 2021
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer MetastaticStudies 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
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Liaoning Cancer Hospital & Institute, Wuhan University, China-Japan Union Hospital, Jilin University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, West China Hospital, Shanxi Province Cancer Hospital, Peking Union Medical College Hospital
- 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 Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646564
- Sponsor's protocol ID
- NCC2493
- Status last verified
- Jan 2022
- First submitted
- 10 Nov 2020
- Last updated
- 11 Jan 2022
- 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 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Therapy With or Without Local Radiotherapy for Extracranial Oligometastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT04646564
- Acronym / sponsor ID
- NCC2493
- Conditions
- Breast Cancer Metastatic
- Keywords
- breast neoplasm, oligometastases, radiotherapy, stereotactic ablative radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Liaoning Cancer Hospital & Institute, Wuhan University, China-Japan Union Hospital, Jilin University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, West China Hospital, Shanxi Province Cancer Hospital, Peking Union Medical College Hospital
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 30 Nov 2020 (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.
More and more evidence suggests that local radiotherapy can improve the outcomes for patients with oligometastatic disease. The purpose of this study is to assess the impact of radiotherapy, compared with standard systemic therapy alone, on survival, local control and toxicities in patients with extracranial oligometastatic breast cancer. Eligible patients are randomized in a 1:2 ratio between the control arm (standard systemic therapy), and the WLRT arm (standard systemic therapy + radiotherapy). Randomization will be stratified by three factors: visceral metastasis (yes vs.no), number of metastases(≤2 vs. >2), hormone receptor(positive vs. negative). SBRT technique is preferred. 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 |
|---|---|---|
| control arm | Active comparator | Drug: standard of carestandard of care |
| study arm | Experimental | Drug: standard of care, Radiation: radiotherapy + standard of careradiotherapy + standard of care |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-70 years old
- ECOG performance status 0-2.
- Newly-diagnosed or metachronous extracranial oligometastatic diseases confirmed by pathology or imaging, with or without locoregional disease (biopsy of metastasis is preferred).
- Total number of locoregional and metastatic lesions of 1-5 , the maximum diameter of lesions ≤5 cm and at least one lesion could be evaluated by RECIST1.1.
- Have received or plan to receive systemic therapy.
Key exclusion criteria (7 listed)
- Have metastases in the central nervous system.
- have indications for palliative radiotherapy to reduce symptoms, such as pain, bleeding, obstruction, and pending fractures caused by the tumor.
- Have moderate/severe liver dysfunction (Child Pugh B or C) from liver metastases, .
- Malignant pleural effusion
- Unable to tolerate radiotherapy due to serious comorbidity
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 |
|---|---|---|
| standard of carepatients receive appropriate therapy at the discretion of the treating oncologist, i.e. systemic therapy according to molecular subtypes, including chemotherapy, endocrine therapy, targeted therapy, or immunotherapy. | Drug | control arm, study arm |
| radiotherapy + standard of carePatients receive radiotherapy to all known metastases. SBRT technique is preferred, especially for metastases in bone, lung and liver. Conventional RT can be used when SBRT is not appropriate, such as metastasis in mediastinal or contralateral supraclavicular nodal regions. Total doses of 30Gy to 50Gy in 5 fractions for SBRT are recommended depending on the tolerance of adjacent normal tissue. Total dose of 60Gy in 25 fractions is recommended for conventional RT. Patients can receive systemic therapy concurrently with RT at the discretion of treating radiation oncologist. After completion of SBRT to all sites of known metastatic disease, patients will continue standard of care therapy per the treating oncologist. | Radiation | study arm |
Primary outcome
Progression-free Survival
Time frame: 2 years
Time from randomization to disease progression at any site or death.
6 secondary outcomes
Overall Survival
Time frame: 2 years
Local control rate
Time frame: 2 years
Incidence of toxicities
Time frame: 2 years
Quality of Life measured by the Functional Assessment of Cancer Therapy- General (FACT-G)
Time frame: 2 years
Translational exploration
Time frame: 2 years
Proportion of acceptable SBRT completion
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Breast Cancer Metastatic, run by Chinese Academy of Medical Sciences at 2 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 8 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: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu-lian Wang, M.D (8610-87788803, wangsl@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (time frame: 2 years). 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 11 Jan 2022.