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New treatment option for Anatomic Stage IV Breast Cancer AJCC v8
Official title Stereotactic Body Radiation Therapy and FES PET/CT Imaging for the Treatment of Oligoprogressive Estrogen Receptor Positive Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT06260033
What this study is testing
What is F-18 16 Alpha-Fluoroestradiol?
F-18 16 Alpha-Fluoroestradiol is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for anatomic stage iv breast cancer ajcc v8.
Also referred to as 16 alpha-fluroestradiol-17 beta, F-18 FES.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
- Patients that have only liver metastases will not be allowed
- Females only: Pregnant or breastfeeding
See the full eligibility 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...
- 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...
- 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...
- 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...
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
- 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...
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Irvine, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Irvine, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.