Anatomic Stage IV Breast Cancer AJCC v8Phase 2NCT05315687
Radioembolization of Metastatic Breast Cancer to the Liver as a 2nd/3rd Line Therapy
A Phase 2 study testing Y-90 SIR-Spheres, Yttrium-90 Microsphere Radioembolization and Systemic Therapy in people with Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, run by Emory University at 1 site in United States.
Trial summary
This phase II trial studies the effects of radioembolization with yttrium Y-90 works as a 2nd or 3rd line therapy for treating patients with breast cancer that has spread to the liver (metastatic to the liver). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Carcinoma in the Liver
- What is being tested?
- Y-90 SIR-Spheres, Yttrium-90 Microsphere Radioembolization and Systemic Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2022to 31 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Biopsy proven metastatic breast cancer to the liver (liver biopsy including routine genetic profiling) if not performed before, the biopsy will be performed at the time of shunt of study/mapping.
- The metastatic breast cancer to the liver or the primary metastatic breast cancer with one of the following receptor profiling: 1. Triple Negative Breast Cancer (TNBC) (i.e ER-, PR-, HER2-); 2. ER+, PR+, HER2-; 3. ER+, PR-, HER2-; 4. ER-, PR+, HER2-. HER2 negative breast cancer is defined as IHC result of 0 or 1+ in a core needle biopsy specimen of primary breast cancer.
- Tumor burden =< 50% of liver
Show all 28Show fewer
- Baseline HIDA scan demonstrating normal liver function
- No radiographic, clinical or biopsy evidence of cirrhosis
- Patients to be enrolled in either arm of the study should be deemed appropriate candidate for permissible lines of systemic therapies
- If applicable, patients must have stable brain metastasis (mets) defined as unchanged CNS disease in the past 6 months.
- Life expectancy > 12 weeks as determined by the Investigator
- Hemoglobin >= 8.0 g/dl (within 28 days of cycle 1 day 1)
- White blood cell (WBC) >= 1500/uL (after at least 7 days without growth factor support or transfusion) (within 28 days of cycle 1 day 1)
- Absolute neutrophil count (ANC) >= 1,000/mcL (after at least 7 days without growth factor support or transfusion) (within 28 days of cycle 1 day 1)
- Platelets >= 50,000/mcL (no transfusions allowed within 7 days of day 1 to meet entry criteria) (within 28 days of cycle 1 day 1)
- Prothrombin time (PT)/international normalized ratio (INR) < 1.5 (within 28 days of cycle 1 day 1)
- Total bilirubin =< 2 X institutional upper limit of normal (ULN) (within 28 days of cycle 1 day 1)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 5X institutional upper limit of normal (ULN) (within 28 days of cycle 1 day 1)
- Serum creatinine =< 2 mg/dL (or glomerular filtration rate >= 40 mL/min) (within 28 days of cycle 1 day 1)
- Lipase and amylase =< 1.5 x ULN (within 28 days of cycle 1 day 1)
- The effects of Y90 radioembolization/chemotherapy on the developing human fetus are unknown. For this reason, female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy
- FCBP and men treated or enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry for the duration of study participation, and X months after completion of treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- A female of childbearing potential (FCBP) is a sexually mature woman who:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months. This will be assess during screening's H\&P by reviewing with subject her reproductive history.
- No surgery, radiotherapy, chemotherapy, immunotherapy, or investigational therapy within 14 days of initiation of therapy on study
- Willingness and ability of the subject to comply with scheduled visits, drug \& device administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions
- Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation
Who cannot join
- HER2+ breast cancer regardless of ER and PR status.
- Patients who have had chemotherapy or within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier (i.e., have residual toxicities > grade 1)
- Patients who are receiving any other investigational agents or an investigational device within 14 days before starting treatment
- Any prior liver directed intervention (surgical or liver directed therapy for metastatic breast cancer)
- Extrahepatic disease (other than permissible criteria described above).
- Patient with insurance denial for Y90 treatment Consented participants for which Y90 treatment pre-certification was not obtained. This subjects will be considered as a screen failure.
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
About this study
Official title: Safety and Efficacy of Radioembolization of Metastatic Breast Cancer to the Liver as a 2nd/3rd Line Therapy
This phase II trial studies the effects of radioembolization with yttrium Y-90 works as a 2nd or 3rd line therapy for treating patients with breast cancer that has spread to the liver (metastatic to the liver). Yttrium Y-90 radioembolization is a therapy that injects radioactive particles directly into an artery that feeds liver tumors to cut off their blood supply.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the efficacy of Y90 radioembolization as a 2nd or 3rd line therapeutic option in conjunction with systemic therapy by assessing progression free survival (PFS).
SECONDARY OBJECTIVES:
- To evaluate the safety of Y90 radioembolization as a 2nd or 3rd line therapeutic option in conjunction with systemic therapy by evaluating treatment related toxicities and identifying baseline predictors of treatment related toxicity.
II. To evaluate the impact of tumor biology i.e. triple negative breast cancer (TNBC) versus (vs.) non-TNBC on PFS and toxicity.
III. To evaluate quality of life (QOL) changes in patients receiving Y90 versus others.
IV. To evaluate the survival (OS) benefit of addition of Y90 radioembolization to systemic therapy.
- To evaluate compare inflammatory changes in the in the targeted tumors before and after Y90 radioembolization for identification of potential synergistic immunotherapy pathways.
VI. To identify genetic biomarkers of treatment response to Y90 radioembolization.
VII. Evaluation of efficacy and accuracy of hepatobiliary iminodiacetic acid (HIDA) scan as a tool to objectively quantify baseline and post treatment hepatic dysfunction.
VIII. Evaluating timing of Y90 relative to lines of therapies already utilized and disease course.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive systemic therapy. Beginning 1-6 weeks after starting systemic therapy, patients also undergo Y90 radioembolization.
ARM II: Patients receive systemic therapy.
After completion of study treatment, patients are followed up at 4-8 weeks, and then every 12-16 weeks for 2 years.
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Carcinoma in the Liver, Prognostic Stage IV Breast Cancer AJCC v8
- Being tested
- Y-90 SIR-Spheres, Yttrium-90 Microsphere Radioembolization, Systemic Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y-90 SIR-SpheresDevice
Y-90 SIR-Spheres
Yttrium-90 Microsphere RadioembolizationProcedure or surgery
Also called Yttrium Y 90 Microsphere Therapy, Yttrium-90 Radioembolization
Undergo Y90 radioembolization
Systemic TherapyOther
Systemic Therapy
| Study group | Role | What they receive |
|---|---|---|
| Arm I (systemic therapy, Y90 radioembolization) | Experimental | Patients receive systemic therapy. Beginning 1-6 weeks after starting systemic therapy, patients also undergo Y90 radioembolization. Receives: Device: Y-90 SIR-Spheres; Procedure: Yttrium-90 Microsphere Radioembolization; Other: Systemic Therapy |
| Arm II (systemic therapy) | Active comparator | Patients receive systemic therapy. Receives: Other: Systemic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver and overall progression free survival (PFS)
Progression of disease is defined objectively by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 using magnetic resonance imaging (MRI) or computed tomography (CT) and/or by positron emission tomography (PET) using PET Response Criteria in Solid Tumors (PERCIST) criteria. PFS will be estimated using the Kaplan-Meier method, and treatment groups will be compared using log-rank tests. Median PFS will be reported, along with a 95% confidence interval estimated using the Brookmeyer-Crowley method.
Measured: From date of randomization to date of progression or death, where those alive without progression are censored at date of last imaging scan, assessed up to 24 months
Secondary outcomes (1)
Liver progression free survival (PFS)
Liver progression is defined as progression of disease in the liver only by RECIST 1.1 or PERCIST criteria. Liver PFS will be estimated using the Kaplan-Meier method, and treatment groups will be compared using log-rank tests. Median liver PFS will be reported, along with a 95% confidence interval estimated using the Brookmeyer-Crowley method.
Measured: From date of randomization to date of liver progression or death, where those alive without liver progression are censored at date of last imaging scan, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start17 Aug 2022
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Why it stopped: Study is being closed because PI left Emory
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anatomic Stage IV Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Sirtex Medical
- Responsible party
- Principal investigator, Nima Kokabi, Emory University
- Investigators
- Nima Kokabi, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315687
- Sponsor's protocol ID
- STUDY00002373
- Other IDs
- NCI-2021-03144, STUDY00002373, RAD5251-21, P30CA138292
- Status last verified
- Jan 2024
- First submitted
- 22 Mar 2022
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Wu R, Gogineni K, Meisel J, Szabo S, Thirunavu M, Friend S, Bercu Z, Sethi I, Natarajan N, Switchenko J, Levy J, Abdalla E, Weakland L, Kalinsky K, Kokabi N. Study Protocol: Efficacy and Safety of Radioembolization (REM) as an Early Modality (EM) Therapy for Metastatic Breast Cancer (BR) to the Liver with Y90 (REMEMBR Y90). Cardiovasc Intervent Radiol. 2022 Nov;45(11):1725-1734. doi: 10.1007/s00270-022-03254-4. Epub 2022 Aug 25.
PubMed 36008574
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Radioembolization of Metastatic Breast Cancer to the Liver as a 2nd/3rd Line Therapy
- ClinicalTrials.gov ID
- NCT05315687
- Acronym / sponsor ID
- STUDY00002373
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Carcinoma in the Liver, Prognostic Stage IV Breast Cancer AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study is being closed because PI left Emory
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Sirtex Medical
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies the effects of radioembolization with yttrium Y-90 works as a 2nd or 3rd line therapy for treating patients with breast cancer that has spread to the liver (metastatic to the liver). Yttrium Y-90 radioembolization is a therapy that injects radioactive particles directly into an artery that feeds liver tumors to cut off their blood supply.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the efficacy of Y90 radioembolization as a 2nd or 3rd line therapeutic option in conjunction with systemic therapy by assessing progression free survival (PFS).
SECONDARY OBJECTIVES:
- To evaluate the safety of Y90 radioembolization as a 2nd or 3rd line therapeutic option in conjunction with systemic therapy by evaluating treatment related toxicities and identifying baseline predictors of treatment related toxicity.
II. To evaluate the impact of tumor biology i.e. triple negative breast cancer (TNBC) versus (vs.) non-TNBC on PFS and toxicity.
III. To evaluate quality of life (QOL) changes in patients receiving Y90 versus others.
IV. To evaluate the survival (OS) benefit of addition of Y90 radioembolization to systemic therapy.
- To evaluate compare inflammatory changes in the in the targeted tumors before and after Y90 radioembolization for identification of potential synergistic immunotherapy pathways.
VI. To identify genetic biomarkers of treatment response to Y90 radioembolization.
VII. Evaluation of efficacy and accuracy of hepatobiliary iminodiacetic acid (HIDA) scan as a tool to objectively quantify baseline and post treatment hepatic dysfunction.
VIII. Evaluating timing of Y90 relative to lines of therapies already utilized and disease course.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive systemic therapy. Beginning 1-6 weeks after starting systemic therapy, patients also undergo Y90 radioembolization.
ARM II: Patients receive systemic therapy.
After completion of study treatment, patients are followed up at 4-8 weeks, and then every 12-16 weeks for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (systemic therapy, Y90 radioembolization) | Experimental | Device: Y-90 SIR-Spheres, Procedure: Yttrium-90 Microsphere Radioembolization, Other: Systemic TherapyPatients receive systemic therapy. Beginning 1-6 weeks after starting systemic therapy, patients also undergo Y90 radioembolization. |
| Arm II (systemic therapy) | Active comparator | Other: Systemic TherapyPatients receive systemic therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Male or female
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Biopsy proven metastatic breast cancer to the liver (liver biopsy including routine genetic profiling) if not performed before, the biopsy will be performed at the time of shunt of study/mapping.
- The metastatic breast cancer to the liver or the primary metastatic breast cancer with one of the following receptor profiling: 1. Triple Negative Breast Cancer (TNBC) (i.e ER-, PR-, HER2-); 2. ER+, PR+, HER2-; 3. ER+, PR-, HER2-; 4. ER-, PR+, HER2-. HER2 negative breast cancer is defined as IHC result of 0 or 1+ in a core needle biopsy specimen of primary breast cancer.
Key exclusion criteria (6 listed)
- HER2+ breast cancer regardless of ER and PR status.
- Patients who have had chemotherapy or within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier (i.e., have residual toxicities > grade 1)
- Patients who are receiving any other investigational agents or an investigational device within 14 days before starting treatment
- Any prior liver directed intervention (surgical or liver directed therapy for metastatic breast cancer)
- Extrahepatic disease (other than permissible criteria described above).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Y-90 SIR-SpheresY-90 SIR-Spheres | Device | Arm I (systemic therapy, Y90 radioembolization) |
| Yttrium-90 Microsphere RadioembolizationAlso: Yttrium Y 90 Microsphere Therapy, Yttrium-90 RadioembolizationUndergo Y90 radioembolization | Procedure or surgery | Arm I (systemic therapy, Y90 radioembolization) |
| Systemic TherapySystemic Therapy | Other | Arm I (systemic therapy, Y90 radioembolization), Arm II (systemic therapy) |
Primary outcome
Liver and overall progression free survival (PFS)
Time frame: From date of randomization to date of progression or death, where those alive without progression are censored at date of last imaging scan, assessed up to 24 months
Progression of disease is defined objectively by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 using magnetic resonance imaging (MRI) or computed tomography (CT) and/or by positron emission tomography (PET) using PET Response Criteria in Solid Tumors (PERCIST) criteria. PFS will be estimated using the Kaplan-Meier method, and treatment groups will be compared using log-rank tests. Median PFS will be reported, along with a 95% confidence interval estimated using the Brookmeyer-Crowley method.
1 secondary outcome
Liver progression free survival (PFS)
Time frame: From date of randomization to date of liver progression or death, where those alive without liver progression are censored at date of last imaging scan, assessed up to 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Derived from this study: PubMed 36008574Wu R, Gogineni K, Meisel J, Szabo S, Thirunavu M, Friend S, Bercu Z, Sethi I, Natarajan N, Switchenko J, Levy J, Abdalla E, Weakland L, Kalinsky K, Kokabi N. Study Protocol: Efficacy and Safety of Radioembolization (REM) as an Early Modality (EM) Therapy for Metastatic Breast Cancer (BR) to the Liver with Y90 (REMEMBR Y90). Cardiovasc Intervent Radiol. 2022 Nov;45(11):1725-1734. doi: 10.1007/s00270-022-03254-4. Epub 2022 Aug 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nima Kokabi principal investigator
Emory University Hospital/Winship Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Y-90 SIR-Spheres, Yttrium-90 Microsphere Radioembolization and Systemic Therapy in people with Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver and overall progression free survival (PFS) (time frame: From date of randomization to date of progression or death, where those alive without progression are censored at date of last imaging scan, assessed up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05315687, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.