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

Phase 2

Recruiting

• Conditions: Recurrent Breast Cancer; Estrogen Receptor Positive Tumor; Her2-negative Tumor; Breast Cancer; Stereotactic Body Radiotherapy; Surgery
• Interventions: Procedure: Surgical resection; Radiation: Stereotactic body radiotherapy; Procedure: Radiofrequency ablation

• Registration Number: NCT03750396
• Lead Sponsor: Gangnam Severance Hospital

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.

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2018-11-16
• Study First Submitted QC: 2018-11-20
• Study First Posted: 2018-11-23
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-12
• Last Update Posted: 2019-02-15
• Primary Completion: 2021-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endocrine and local treatments	Surgical resection	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
Endocrine and local treatments	Stereotactic body radiotherapy	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
Endocrine and local treatments	Radiofrequency ablation	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

Primary Outcome Measures

Name	Time	Method
Progression-free survival	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

Name	Time	Method
Overall survival	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

Trial Locations

Locations (1)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of