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

Primary Purpose

Breast Cancer, Recurrent Breast Cancer, Stereotactic Body Radiotherapy

Status

Recruiting

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Surgical resection

Stereotactic body radiotherapy

Radiofrequency ablation

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Oligometastasis, Local treatments

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Gangnam Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endocrine and local treatments

Arm Description

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

Outcomes

Primary Outcome Measures

Progression-free survival

Failure: progression or death due to any cause

Secondary Outcome Measures

Overall survival

Failure: death due to any cause

Full Information

NCT ID

NCT03750396

First Posted

November 16, 2018

Last Updated

February 12, 2019

Sponsor

Gangnam Severance Hospital

Collaborators

Severance Hospital, Samsung Medical Center, Asan Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03750396

Brief Title

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

Acronym

CLEAR

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2018 (Actual)

Primary Completion Date

July 31, 2021 (Anticipated)

Study Completion Date

July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gangnam Severance Hospital

Collaborators

Severance Hospital, Samsung Medical Center, Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Recurrent Breast Cancer, Stereotactic Body Radiotherapy, Estrogen Receptor Positive Tumor, Her2-negative Tumor, Surgery

Keywords

Oligometastasis, Local treatments

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Endocrine and local treatments

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Surgical resection

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Stereotactic body radiotherapy

Other Intervention Name(s)

SBRT

Intervention Description

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).

Intervention Type

Procedure

Intervention Name(s)

Radiofrequency ablation

Other Intervention Name(s)

RFA

Intervention Description

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.

Primary Outcome Measure Information:

Title

Progression-free survival

Description

Failure: progression or death due to any cause

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

Secondary Outcome Measure Information:

Title

Overall survival

Description

Failure: death due to any cause

Time Frame

From the date of registration to the date of death or last follow-up; assessed up to 10 years

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Biologically woman

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sung Gwe Ahn, Ph.D.

Phone

82-2-2019-4402

asg2004@yuhs.ac

First Name & Middle Initial & Last Name or Official Title & Degree

Joon Jeong, Ph.D.

Phone

82-2-2019-3379

gsjjoon@yuhs.ac

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joon Jeong, Ph.D.

Organizational Affiliation

Gangnam Severance Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gangnam Severance Hospital

City

Seoul

ZIP/Postal Code

135720

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joon Jeong, M.D.,Ph.D.

Phone

82220193370

gsjjoon@yuhs.ac

First Name & Middle Initial & Last Name & Degree

Sung Gwe Ahn, M.D.

Phone

82220193370

asg2004@yuhs.ac

12. IPD Sharing Statement

Learn more about this trial

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

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