Using targeted radiation therapy for treating specific metastatic breast cancer cases
A Phase II Trial of Stereotactic Body Radiation Therapy and Fluoroestradiol Positron Emission Tomography in Patients With Oligoprogressive Estrogen Receptor Positive Metastatic Breast Cancer
This study is testing if a targeted radiation treatment can help people with certain types of metastatic breast cancer keep taking their regular medication for at least 24 weeks while also checking how it affects their safety and quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 2 sites (Duarte, California and 1 other locations) |
| Trial ID | NCT06260033 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the effectiveness of stereotactic body radiation therapy (SBRT) in patients with estrogen receptor positive metastatic breast cancer that has limited progression. The study aims to determine if SBRT allows patients to continue their current systemic therapy for at least 24 weeks while assessing the safety and quality of life impacts. Patients will receive SBRT in 3 to 5 fractions over a few weeks, and the study will also explore the use of FES-PET imaging to identify lesions before and after treatment. The trial includes various assessments of patient outcomes and adverse events.
Who should consider this trial
Good fit: Ideal candidates are adults with estrogen receptor positive metastatic breast cancer experiencing limited disease progression.
Not a fit: Patients with more than four sites of disease progression or those with certain complications like malignant pleural effusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help patients maintain their current treatment regimen while effectively managing their cancer progression.
How similar studies have performed: Other studies have shown promising results with SBRT in similar contexts, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Duarte, California and 1 other locations
- City of Hope Medical Center — Duarte, California, United States (Recruiting)
- City of Hope at Irvine Lennar — Irvine, California, United States (Recruiting)
Study contacts
- Principal investigator: Jose G Bazan — City of Hope Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.