A Phase II Study of Radiation Therapy to Treat Refractory Breast Cancer

N/ANot Yet RecruitingNCT07672743

Cancer Institute and Hospital, Chinese Academy of Medical Sciences29 enrolled

Overview

For locally advanced or recurrent metastatic breast cancer that is resistant to systemic therapy, radiotherapy (RT) may be considered as the preferred treatment option when the lesion is unresectable, or the patient is not suitable for surgery. This study aim to evelatuate the local control of radical dose RT or new RT technique (such as patially fractionated radiation therapy, SFRT) for the locally advanced or recurrent metastatic breast cancer.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Radical dose radiotherapyRADIATION

Radical dose is delivered for the patients. SFRT is recommended for the patients with bulky tumor (such as ≥ 5cm). SFRT is delivered with 12-20Gy (1 fraction) followed by external beam radiation therapy (EBRT) with EQD2≥60Gy.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; * Locally advanced or recurrent metastatic breast cancer, pathologically confirmed; * At least one extracranial measurable lesion suitable for radiotherapy; * Signature of informed consent form. Exclusion Criteria: * Pregnant or lactation women; * Severe concomitant conditions, including persistent or active infections, symptomatic congestive heart failure, unstable angina pectoris, and serious arrhythmias et al.

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Overall Response Rate (ORR)

Time frame: 3 months

Secondary Outcomes

Overall Response Rate (ORR)

Time frame: 1 month

Local control

Time frame: 1 year

Progression-Free Survival (PFS)

Time frame: 1 year

Overall Survival (OS)

Time frame: 1 year

Number of participants with treatment-related acute and late adverse events as assessed by CTCAE v5.0

Time frame: 1 year

Data from ClinicalTrials.gov

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