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

Yonsei University Health System (YUHS)

Status and phase: Enrolling; Phase 2

Conditions: Breast Cancer; Surgery; Her2-negative Tumor; Estrogen Receptor Positive Tumor; Recurrent Breast Cancer; Stereotactic Body Radiotherapy

Treatments: Procedure: Radiofrequency ablation; Procedure: Surgical resection; Radiation: Stereotactic body radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03750396

CLEAR

Details and patient eligibility

About

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

Full 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.

Enrollment: 110 estimated patients

Sex: Female

Ages: 20 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Endocrine and local treatments

Experimental group

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

Treatment:

Procedure: Surgical resection

Procedure: Radiofrequency ablation

Radiation: Stereotactic body radiotherapy