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

NCT03750396 | Unknown Phase 2

• 1 other identifier: CLEAR
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Oligometastasis; Local treatments

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Failure: progression or death due to any cause

  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

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

Study Arms (1)

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

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

Interventions

Surgical resection PROCEDURE

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

Endocrine and local treatments

Stereotactic body radiotherapy RADIATION

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).

Also known as: SBRT

Endocrine and local treatments

Radiofrequency ablation PROCEDURE

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.

Also known as: RFA

Endocrine and local treatments

Eligibility Criteria

• Age: 20 Years - 75 Years
• Gender Eligibility Details: Biologically woman
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead
• Severance Hospital: collaborator
• Samsung Medical Center: collaborator
• Asan Medical Center: collaborator

Study Sites (1)

Gangnam Severance Hospital

Seoul, 135720, South Korea

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiosurgery; Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Radiofrequency Therapy; Ablation Techniques

Study Officials

• Joon Jeong, Ph.D.

  Gangnam Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung Gwe Ahn, Ph.D.

CONTACT

82-2-2019-4402; asg2004@yuhs.ac

Joon Jeong, Ph.D.

CONTACT

82-2-2019-3379; gsjjoon@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 23, 2018
• Study Start: August 1, 2018
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2025
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

KR (1)