Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06260033
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-01-11
Brief Title:
Stereotactic Body Radiation Therapy and FES PETCT Imaging for the Treatment of Oligoprogressive Estrogen Receptor Positive Metastatic Breast Cancer
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
A Phase II Trial of Stereotactic Body Radiation Therapy and Fluoroestradiol Positron Emission Tomography in Patients With Oligoprogressive Estrogen Receptor Positive Metastatic Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial tests how well stereotactic body radiation therapy SBRT works in treating patients with estrogen receptor positive ER breast cancer that has spread from where it first started to other places in the body metastatic and has limited disease progression oligoprogression Currently the standard of care for breast cancer patients with oligoprogressive disease is to change systemic therapy when progression occurs Radiation therapy uses high energy x-rays particles or radioactive seeds to kill cancer cells and shrink tumors SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body except the brain The total dose of radiation is divided into smaller doses fractions given over several days This type of radiation therapy helps spare normal tissue and has been shown to improve survival SBRT may kill more tumor cells and allow patients with oligoprogressive ER metastatic breast cancer to continue taking current systemic treatment
This trial also tests how well ER targeted positron emission tomography PET computed tomography CT imaging using FES works in identifying progressive disease in patients with ER metastatic breast cancer FES a radiolabeled substance binds to estrogen receptors and gives off radiation that can be detected by a PET scan The PET scan an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer FES forms an image that shows where tumor cells with estrogen receptors can be found in the body CT images use x-rays to provide an exact outline of organs FES PETCT may improve identification of progressive disease in patients with ER metastatic breast cancer
This trial also tests how well ER targeted positron emission tomography PET computed tomography CT imaging using FES works in identifying progressive disease in patients with ER metastatic breast cancer FES a radiolabeled substance binds to estrogen receptors and gives off radiation that can be detected by a PET scan The PET scan an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer FES forms an image that shows where tumor cells with estrogen receptors can be found in the body CT images use x-rays to provide an exact outline of organs FES PETCT may improve identification of progressive disease in patients with ER metastatic breast cancer
Detailed Description:
PRIMARY OBJECTIVE
I To determine whether using SBRT to treat oligoprogressive lesions allows ER breast cancer patients to continue on their current systemic therapy for at least 24 weeks post SBRT treatment
SECONDARY OBJECTIVES
I To evaluate adverse events Common Terminology Criteria in Adverse Events CTCAE and Patient-Reported Outcomes PRO-CTCAE in patients who receive SBRT
II To assess whether F-18 16 alpha-fluoroestradiol FES-PET increases the number of lesions found prior to SBRT
III To determine the impact of SBRT on patient quality of life using the European Organization for the Research and Treatment of Cancer EORTC Quality of Life Questionnaire QLQ-C30 and QLQ-BR45
IV To estimate time to the next line of systemic therapy in patients who receive SBRT for oligoprogression
V To estimate progression-free survival time in patients who receive SBRT for oligoprogression
EXPLORATORY OBJECTIVES
I To assess whether FES-PET increases the number of lesions found after SBRT II To describe circulating tumor deoxyribonucleic acid ctDNA levels over time after SBRT treatment
III To identify potential predictors of outcomes to treatment with SBRT
OUTLINE
Patients currently taking selective estrogen receptor modulators SERMsselective estrogen receptor degraders SERDs immediately undergo 3 or 5 treatment fractions of SBRT within 3 weeks in the absence of unacceptable toxicity or evidence of 4 sites of disease progression Patients not currently taking SERMsSERDs first receive F-FES intravenously IV and undergo PETCT scans at baseline After baseline FES PETCT patients with 4 sites of progressive disease then undergo 3 or 5 treatment fractions of SBRT within 3 weeks in the absence of unacceptable toxicity or evidence of 4 sites of disease progression All patients undergo FES PETCT at 12 and 24 weeks Patients with stable disease SD after 12 or 24 week FES PETCT may continue standard systemic therapy Patients with 4 sites of progressive disease after 12 or 24 week FES PETCT may receive SBRT to additional sites in the absence of unacceptable toxicity or evidence of 4 sites of disease progression All patients also undergo CT PETCT or bone scans and blood samples collection during screening and on study
After completion of study intervention patients are followed up at 30 days
I To determine whether using SBRT to treat oligoprogressive lesions allows ER breast cancer patients to continue on their current systemic therapy for at least 24 weeks post SBRT treatment
SECONDARY OBJECTIVES
I To evaluate adverse events Common Terminology Criteria in Adverse Events CTCAE and Patient-Reported Outcomes PRO-CTCAE in patients who receive SBRT
II To assess whether F-18 16 alpha-fluoroestradiol FES-PET increases the number of lesions found prior to SBRT
III To determine the impact of SBRT on patient quality of life using the European Organization for the Research and Treatment of Cancer EORTC Quality of Life Questionnaire QLQ-C30 and QLQ-BR45
IV To estimate time to the next line of systemic therapy in patients who receive SBRT for oligoprogression
V To estimate progression-free survival time in patients who receive SBRT for oligoprogression
EXPLORATORY OBJECTIVES
I To assess whether FES-PET increases the number of lesions found after SBRT II To describe circulating tumor deoxyribonucleic acid ctDNA levels over time after SBRT treatment
III To identify potential predictors of outcomes to treatment with SBRT
OUTLINE
Patients currently taking selective estrogen receptor modulators SERMsselective estrogen receptor degraders SERDs immediately undergo 3 or 5 treatment fractions of SBRT within 3 weeks in the absence of unacceptable toxicity or evidence of 4 sites of disease progression Patients not currently taking SERMsSERDs first receive F-FES intravenously IV and undergo PETCT scans at baseline After baseline FES PETCT patients with 4 sites of progressive disease then undergo 3 or 5 treatment fractions of SBRT within 3 weeks in the absence of unacceptable toxicity or evidence of 4 sites of disease progression All patients undergo FES PETCT at 12 and 24 weeks Patients with stable disease SD after 12 or 24 week FES PETCT may continue standard systemic therapy Patients with 4 sites of progressive disease after 12 or 24 week FES PETCT may receive SBRT to additional sites in the absence of unacceptable toxicity or evidence of 4 sites of disease progression All patients also undergo CT PETCT or bone scans and blood samples collection during screening and on study
After completion of study intervention patients are followed up at 30 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-11094 | REGISTRY | None | None |
| 23353 | OTHER | None | None |
| P30CA033572 | NIH | City of Hope Medical Center | httpsreporternihgovquickSearchP30CA033572 |