Stereotactic Body Radiation Therapy and FES PET/CT Imaging for the Treatment of Oligoprogressive Estrogen Receptor Positive Metastatic Breast Cancer
A Phase II Trial of Stereotactic Body Radiation Therapy and Fluoroestradiol Positron Emission Tomography in Patients With Oligoprogressive Estrogen Receptor Positive Metastatic Breast Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: X-rays, CT scans, PET scans, Questionnaires, Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors."
- "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."
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests focused radiation called SBRT for breast cancer that uses estrogen to grow and has spread, with only a few spots getting worse. It tests whether SBRT can let patients stay on their current cancer medicine. It also tests whether FES PET/CT scans, which use a radioactive tracer that attaches to estrogen receptors, can better find cancer that is getting worse.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older, of any sex, and give written consent yourself or through a legal representative.
- Be able to care for yourself and be up and about at least half of your waking hours. Read and understand English or Spanish for study forms.
- Have breast cancer confirmed by a tissue test that has spread and is estrogen receptor positive (ER+), meaning it uses estrogen to grow. Any PR or HER2 test result is allowed.
- Have 1–4 cancer spots outside the brain getting worse, based on scans or your cancer doctor's judgment. Worsening spots in the breast or same-side armpit count as one site.
- All worsening spots must have clear edges and be safe to treat with SBRT in 3–5 sessions, including near areas treated with radiation before.
- Previously treated brain tumors must be stable. Cancer must not be getting worse in the brain, and there must be no past or current cancer in the lining around the brain or spinal cord.
- If you can become pregnant, have a negative pregnancy test.
- If you or your partner could become pregnant, use effective birth control or avoid sex that could cause pregnancy during the study and for at least 1 month after the last study treatment.
Who can't join
- The listing places having 1–3 prior courses of whole-body treatment for cancer that has spread under exclusions. Ask the study team to clarify this rule.
- Recent cancer treatment within 7–14 days before SBRT, as decided by the doctor. Chemotherapy must stop during SBRT and may restart 7–14 days afterward. Hormone therapy may continue with the doctor's approval.
- An uncontrolled illness that makes whole-body cancer treatment unsafe.
- Another past or current cancer, unless it is one of the allowed low-risk cancers or the study leader approves it.
- Cancer that has spread only to the liver.
- Pregnancy or breastfeeding.
- More than 4 worsening cancer spots. Worsening cancer-related fluid around the lungs or in the belly, or certain cancer spread through the belly or lungs, counts as more than 4 spots.
- Any other condition that makes study procedures unsafe, or difficulty following all study steps, including travel or scheduling needs.
Simplified for readability. The official criteria below are what the study team uses.
Official 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)
Study sites (2)
CA
- City of Hope Medical Center · Duarte, CA 91010Jose G. Bazan · Study contact · 626-505-7901 · jbazan@coh.orgJose G. Bazan · Principal investigatorMore trials in Duarte
- City of Hope at Irvine Lennar · Irvine, CA 92618Jose G. Bazan · Study contact · 626-505-7901 · jbazan@coh.orgJose G. Bazan · Principal investigatorMore trials in Irvine