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Local Treatment in ER-positive/HER2-negative Oligo-metastatic Breast Cancer (CLEAR)

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ClinicalTrials.gov Identifier: NCT03750396
Recruitment Status : Recruiting
First Posted : November 23, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
Severance Hospital
Samsung Medical Center
Asan Medical Center
Information provided by (Responsible Party):
Joon Jeong, Gangnam Severance Hospital

Brief Summary:
Local treatment in addition to endocrine treatment as 1st line for oligo-metastatic ER-positive/HER2-negative breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Recurrent Breast Cancer Stereotactic Body Radiotherapy Estrogen Receptor Positive Tumor Her2-negative Tumor Surgery Procedure: Surgical resection Radiation: Stereotactic body radiotherapy Procedure: Radiofrequency ablation Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
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
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Endocrine and local treatments

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

Procedure: Surgical resection
Surgical resection for their metastatic lesions will be performed. Achievement of tumor-free margin is not mandatory.

Radiation: Stereotactic body radiotherapy
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).
Other Name: SBRT

Procedure: Radiofrequency ablation
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.
Other Name: RFA




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: From the date of registration to the date of death or last follow-up; assessed up to 10 years ]
    Failure: death due to any cause



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Biologically woman
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-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)

Exclusion Criteria:

  • De Novo metastatic cancer at initial diganosis
  • Recurrence-free inverval < 1 year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03750396


Contacts
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Contact: Sung Gwe Ahn, Ph.D. 82-2-2019-4402 asg2004@yuhs.ac
Contact: Joon Jeong, Ph.D. 82-2-2019-3379 gsjjoon@yuhs.ac

Locations
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Korea, Republic of
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of, 135720
Contact: Joon Jeong, M.D.,Ph.D.    82220193370    gsjjoon@yuhs.ac   
Contact: Sung Gwe Ahn, M.D.    82220193370    asg2004@yuhs.ac   
Sponsors and Collaborators
Gangnam Severance Hospital
Severance Hospital
Samsung Medical Center
Asan Medical Center
Investigators
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Principal Investigator: Joon Jeong, Ph.D. Gangnam Severance Hospital
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Responsible Party: Joon Jeong, Professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT03750396    
Other Study ID Numbers: CLEAR
First Posted: November 23, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joon Jeong, Gangnam Severance Hospital:
Oligometastasis
Local treatments
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases