Trial Title:
Stereotactic Body Radiation Therapy and FES PET/CT Imaging for the Treatment of Oligoprogressive Estrogen Receptor Positive Metastatic Breast Cancer
NCT ID:
NCT06260033
Condition:
Anatomic Stage IV Breast Cancer AJCC v8
Estrogen Receptor-Positive Breast Carcinoma
Metastatic Breast Carcinoma
Conditions: Official terms:
Carcinoma
Breast Neoplasms
Estradiol
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Treatment (SBRT, FES PET/CT)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Bone Scan
Description:
Undergo bone scan
Arm group label:
Treatment (SBRT, FES PET/CT)
Other name:
Bone Scintigraphy
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo PET/CT scan
Arm group label:
Treatment (SBRT, FES PET/CT)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Drug
Intervention name:
F-18 16 Alpha-Fluoroestradiol
Description:
Given IV
Arm group label:
Treatment (SBRT, FES PET/CT)
Other name:
16 alpha-fluroestradiol-17 beta
Other name:
F-18 FES
Other name:
FES
Other name:
Fluorine-18 16 alpha-fluoroestradiol
Other name:
Fluoroestradiol F-18
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET/CT scan
Arm group label:
Treatment (SBRT, FES PET/CT)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron emission tomography (procedure)
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Treatment (SBRT, FES PET/CT)
Intervention type:
Radiation
Intervention name:
Stereotactic Body Radiation Therapy
Description:
Undergo SBRT
Arm group label:
Treatment (SBRT, FES PET/CT)
Other name:
SABR
Other name:
SBRT
Other name:
Stereotactic Ablative Body Radiation Therapy
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 PET/CT 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 (SERMs)/selective
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 SERMs/SERDs first receive F-FES
intravenously (IV) and undergo PET/CT scans at baseline. After baseline FES PET/CT,
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 PET/CT at 12 and 24 weeks. Patients with
stable disease (SD) after 12 or 24 week FES PET/CT may continue standard systemic
therapy. Patients with ≤ 4 sites of progressive disease after 12 or 24 week FES PET/CT
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, PET/CT, or bone scans,
and blood samples collection during screening and on study.
After completion of study intervention, patients are followed up at 30 days.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Documented informed consent of the participant and/or legally authorized
representative
- Age: ≥ 18 years
- Female or male
- Eastern Cooperative Oncology Group (ECOG) ≤ 2
- Ability to read and understand English or Spanish for questionnaires
- Histologically confirmed ER+ (any progesterone receptor [PR] and human epidermal
growth factor receptor 2 [HER2] status is allowed) metastatic breast cancer
- The presence of metastatic breast cancer at the time of study entry with progression
in 1-4 lesions (including new lesions). Patients that have disease progression in
the breast and/or ipsilateral axilla will be considered to have only 1 site of
progression even if multiple nodules/lymph nodes are present. Patients with
progression in > 4 lesions are not allowed. Patients with current progression of
malignant pleural effusions, malignant ascites, abdominal carcinomatosis, and/or
lymphangitic pulmonary involvement are considered to have > 4 metastases (Note that
patients with a history of these conditions earlier in the disease course with no
evidence of progression of these conditions are eligible.)
- Evidence of extracranial disease progression in 1-4 discrete lesions will be defined
by either of the following:
- Progression of disease by Response Evaluation Criteria in Solid Tumors (RECIST)
version (v) 1.1 or PET Response Criteria in Solid Tumors (PERCIST) v 1.0
criteria OR
- Progression of disease in at least 1 but up to 4 lesions as determined by the
patient's treating oncologists such that the treating oncologist recommends
changing to the next line systemic therapy. Note that a patient may not
technically meet RECIST v 1.1 criteria for disease progression in this setting
- SBRT must be feasible for all progressing lesions. Feasibility includes but is not
limited to:
- All progressing lesions must have distinct borders AND
- Progressing lesions may not be located within 3 cm of previously irradiated
critical structures such as the spinal cord, brachial plexus, brainstem,
stomach, and/or small/large bowel that would render the metastasis unsafe to
target with SBRT per the treating radiation oncologist
- Patients with prior treated brain metastases that are stable are allowed. Patients
must not have intracranial disease progression. Patients with prior or current
leptomeningeal disease are not allowed
- All progressing lesions must be amenable to stereotactic body radiation therapy to a
dose of 30 Gy to 40 Gy in 3 to 5 fractions per the treating radiation oncologist
- Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test, If
the urine test is positive or cannot be confirmed as negative, a serum pregnancy
test will be required
- Agreement by females and males of childbearing potential to use an effective method
of birth control or abstain from heterosexual activity for the course of the study
through at least 1 months after the last dose of protocol therapy.
- Childbearing potential defined as not being surgically sterilized (men and
women) or have not been free from menses for > 1 year (women only)
Exclusion Criteria:
- Has received at least one line, but not more than three lines, of systemic therapy
for metastatic disease
- Patients may not have received chemotherapy, radiation therapy, biological therapy,
immunotherapy, or other anti-cancer treatment within 7-14 days of the start of study
therapy (SBRT) at the discretion of treating physician. Chemotherapy must be held
during study therapy and can resume 7-14 days after completion of all study therapy
(SBRT) at the discretion of treating physician. (Patients may continue
anti-endocrine/hormone therapy before, during and after study therapy at the
discretion of the treating medical oncologist.)
- Clinically significant uncontrolled illness such that the patient is no longer a
candidate for systemic therapy
- Prior or concurrent malignancy. Prior malignancies with a low probability of
recurrence requiring treatment such as the following are allowed: carcinoma in situ
of the cervix, non-melanoma skin cancer, and low grade (Gleason score ≤ 6 = Gleason
group 1) localized prostate cancer. Prior malignancies not listed require principal
investigator (PI) approval
- Patients that have only liver metastases will not be allowed
- Females only: Pregnant or breastfeeding
- Any other condition that would, in the Investigator's judgment, contraindicate the
patient's participation in the clinical study due to safety concerns with clinical
study procedures
- Prospective participants who, in the opinion of the investigator, may not be able to
comply with all study procedures (including compliance issues related to
feasibility/logistics)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jose G. Bazan
Phone:
626-505-7901
Email:
jbazan@coh.org
Investigator:
Last name:
Jose G. Bazan
Email:
Principal Investigator
Facility:
Name:
City of Hope at Irvine Lennar
Address:
City:
Irvine
Zip:
92618
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jose G. Bazan
Phone:
626-505-7901
Email:
jbazan@coh.org
Investigator:
Last name:
Jose G. Bazan
Email:
Principal Investigator
Start date:
July 23, 2024
Completion date:
October 29, 2026
Lead sponsor:
Agency:
City of Hope Medical Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
City of Hope Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06260033
