Breast CancerPhase 2CLEARNCT03750396
Local Treatment in ER-positive/HER2-negative Oligo-metastatic Breast Cancer
A Phase 2 study testing Surgical resection, Stereotactic body radiotherapy and Radiofrequency ablation in people with Breast Cancer and Recurrent Breast Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
Local treatment in addition to endocrine treatment as 1st line for oligo-metastatic ER-positive/HER2-negative breast cancer. Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Recurrent Breast Cancer, Stereotactic Body Radiotherapy
- What is being tested?
- Surgical resection, Stereotactic body radiotherapy and Radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2018to 31 Jul 2025
- Phase
- Phase 2
- 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 20 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -ER-positive/HER2-negative in primary tumor
- Oligometastases: ≤ 2 lesions in single organ or site (lung, bone, liver, adrenal glands, distant LNs)
- Recurrent cancer after completion of primary treatment (RFI≥1year)
- Metastatic lesions are feasible for resection or radiotherapy (Size≤3cm)
Who cannot join
- De Novo metastatic cancer at initial diganosis
- Recurrence-free inverval < 1 year
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Severance Hospital
Seoul, 135720
Joon Jeong, M.D.,Ph.D., 82220193370, gsjjoon@yuhs.ac
Sung Gwe Ahn, M.D., 82220193370, asg2004@yuhs.ac
About this study
Official title: Local Treatment in Addition to Endocrine Therapy in ER-positive/HER2-negative Oligo-metastatic Breast Cancer (CLEAR): a Multicentre, Single -Arm, Phase 2 Trial
Local treatment in addition to endocrine treatment as 1st line for oligo-metastatic ER-positive/HER2-negative breast cancer.
Read the detailed description
Local treatment included surgical resection, stereotactic body radiotherapy, palliative radiotherapy, and radiofrequency ablation. Stereotactic body radiotherapy is preferred as a radiation modality.
Endocrine therapies with/without target therapy including CDK4/6 inhibitors or mTOR inhibitors are the mainstay of 1st line treatment for ER-positive/HER2-negative metastatic breast cancer.
- Conditions
- Breast Cancer, Recurrent Breast Cancer, Stereotactic Body Radiotherapy, Estrogen Receptor Positive Tumor, Her2-negative Tumor, Surgery
- Being tested
- Surgical resection, Stereotactic body radiotherapy, Radiofrequency ablation
- Keywords
- Oligometastasis, Local treatments
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical resectionProcedure or surgery
Surgical resection for their metastatic lesions will be performed. Achievement of tumor-free margin is not mandatory.
Stereotactic body radiotherapyRadiation
Also called SBRT
Deliver appropriate metastasis directed radiotherapy while minimizing exposure of surrounding normal tissues. Total radiation dose and fractions are various according to metastatic lesions (57~97.5Gy/6~10 Fraction).
Radiofrequency ablationProcedure or surgery
Also called RFA
RFA is a localized thermal treatment technique designed to induce tumor destruction by heating the tumor tissue to temperatures that exceed 60℃. The alternating current of radiofrequency waves passing down from an uninsulated electrode tip into the surrounding tissues generates changes in the direction of ions and creates ionic agitation and frictional heating. This tissue heating then drives extracellular and intracellular water out of the tissue, resulting in tissue destruction by coagulative necrosis.
| Study group | Role | What they receive |
|---|---|---|
| Endocrine and local treatments | Experimental | Endocrine therapy is a standard-of-care for 1st line treatment in the patients with ER+/HER2- metastatic breast cancer.
Endocrine options included aromatase inhibitors, aromatase inhibitors with CDK4/6 inhibitors, fulvestrant, fulvestrant with CDK4/6 inhibitors, everolimus with exemestane, tamoxifen. For premenopausal women, agents for ovarian function suppression using GnRH agonists or surgical ovarian ablation including bilateral salpingo-oophorectomy are allowed.
Local treatments for metastatic lesions will be added in this group.
Local treatments include modalities described below:
i) Surgical resection: the achievement of tumor-free margin is not obligatory. ii) Stereotactic body radiotherapy iii) Radiofrequency ablation Receives: Procedure: Surgical resection; Radiation: Stereotactic body radiotherapy; Procedure: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Failure: progression or death due to any cause
Measured: From the date of registration to the date of first PFS failure or last follow-up; assessed up to 6 years; Median PFS of all registered patients will be over 30 months
Secondary outcomes (1)
Overall survival
Failure: death due to any cause
Measured: From the date of registration to the date of death or last follow-up; assessed up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start1 Aug 2018
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2025 (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
- Model description
- Endocrine therapy is a standard-of-care for 1st line treatment in the patients with ER+/HER2- metastatic breast cancer. Local treatments for metastatic lesions will be added in this group. All patients will undergo local treatments in addition to endocrine therapies. Local treatments include modalities described below: i) Surgical resection: the achievement of tumor-free margin is not obligatory. ii) Stereotactic body radiotherapy iii) Radiofrequency ablation
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Severance Hospital, Samsung Medical Center, Asan Medical Center
- Responsible party
- Principal investigator, Joon Jeong, Gangnam Severance Hospital
- Investigators
- Joon Jeong, Ph.D., Principal investigator, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750396
- Sponsor's protocol ID
- CLEAR
- Acronym
- CLEAR
- Status last verified
- Feb 2019
- First submitted
- 16 Nov 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Treatment in Addition to Endocrine Therapy in ER-positive/HER2-negative Oligo-metastatic Breast Cancer (CLEAR): a Multicentre, Single -Arm, Phase 2 Trial
- ClinicalTrials.gov ID
- NCT03750396
- Acronym / sponsor ID
- CLEAR / CLEAR
- Conditions
- Breast Cancer, Recurrent Breast Cancer, Stereotactic Body Radiotherapy, Estrogen Receptor Positive Tumor, Her2-negative Tumor, Surgery
- Keywords
- Oligometastasis, Local treatments
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Collaborators
- Severance Hospital, Samsung Medical Center, Asan Medical Center
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 23 Nov 2018 (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.
Local treatment in addition to endocrine treatment as 1st line for oligo-metastatic ER-positive/HER2-negative breast cancer.
Detailed description
Local treatment included surgical resection, stereotactic body radiotherapy, palliative radiotherapy, and radiofrequency ablation. Stereotactic body radiotherapy is preferred as a radiation modality.
Endocrine therapies with/without target therapy including CDK4/6 inhibitors or mTOR inhibitors are the mainstay of 1st line treatment for ER-positive/HER2-negative metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Endocrine therapy is a standard-of-care for 1st line treatment in the patients with ER+/HER2- metastatic breast cancer. Local treatments for metastatic lesions will be added in this group. All patients will undergo local treatments in addition to endocrine therapies. Local treatments include modalities described below: i) Surgical resection: the achievement of tumor-free margin is not obligatory. ii) Stereotactic body radiotherapy iii) Radiofrequency ablation
| Arm | Type | Receives |
|---|---|---|
| Endocrine and local treatments | Experimental | Procedure: Surgical resection, Radiation: Stereotactic body radiotherapy, Procedure: Radiofrequency ablationEndocrine therapy is a standard-of-care for 1st line treatment in the patients with ER+/HER2- metastatic breast cancer. Endocrine options included aromatase inhibitors, aromatase inhibitors with CDK4/6 inhibitors, fulvestrant, fulvestrant with CDK4/6 inhibitors, everolimus with exemestane, tamoxifen. For premenopausal women, agents for ovarian function suppression using GnRH agonists or surgical ovarian ablation including bilateral salpingo-oophorectomy are allowed. Local treatments for metastatic lesions will be added in this group. Local treatments include modalities described below: i) Surgical resection: the achievement of tumor-free margin is not obligatory. ii) Stereotactic body radiotherapy iii) Radiofrequency ablation |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- -ER-positive/HER2-negative in primary tumor
- Oligometastases: ≤ 2 lesions in single organ or site (lung, bone, liver, adrenal glands, distant LNs)
- Recurrent cancer after completion of primary treatment (RFI≥1year)
- Metastatic lesions are feasible for resection or radiotherapy (Size≤3cm)
Key exclusion criteria (2 listed)
- De Novo metastatic cancer at initial diganosis
- Recurrence-free inverval < 1 year
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 |
|---|---|---|
| Surgical resectionSurgical resection for their metastatic lesions will be performed. Achievement of tumor-free margin is not mandatory. | Procedure or surgery | Endocrine and local treatments |
| Stereotactic body radiotherapyAlso: SBRTDeliver appropriate metastasis directed radiotherapy while minimizing exposure of surrounding normal tissues. Total radiation dose and fractions are various according to metastatic lesions (57~97.5Gy/6~10 Fraction). | Radiation | Endocrine and local treatments |
| Radiofrequency ablationAlso: RFARFA is a localized thermal treatment technique designed to induce tumor destruction by heating the tumor tissue to temperatures that exceed 60℃. The alternating current of radiofrequency waves passing down from an uninsulated electrode tip into the surrounding tissues generates changes in the direction of ions and creates ionic agitation and frictional heating. This tissue heating then drives extracellular and intracellular water out of the tissue, resulting in tissue destruction by coagulative necrosis. | Procedure or surgery | Endocrine and local treatments |
Primary outcome
Progression-free survival
Time frame: From the date of registration to the date of first PFS failure or last follow-up; assessed up to 6 years; Median PFS of all registered patients will be over 30 months
Failure: progression or death due to any cause
1 secondary outcome
Overall survival
Time frame: From the date of registration to the date of death or last follow-up; assessed up to 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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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.
Joon Jeong, Ph.D. principal investigator
Gangnam Severance Hospital
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 Surgical resection, Stereotactic body radiotherapy and Radiofrequency ablation in people with Breast Cancer and Recurrent Breast Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
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: status not confirmed, as of the sponsor's last update on 15 Feb 2019. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sung Gwe Ahn, Ph.D. (82-2-2019-4402, asg2004@yuhs.ac), 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: From the date of registration to the date of first PFS failure or last follow-up; assessed up to 6 years; Median PFS of all registered patients will be over 30 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 15 Feb 2019.