Breast CancerPhase 1/2NCT02988648
A Clinical Trial Evaluating the Safety and Clinical Activity of Radioiodide (131I-) as a Novel Targeted Therapy for Metastatic Breast Cancer That Overexpresses Functional Na/I Symporter
A Phase 1/2 study testing Radioiodide (131I-) in people with Breast Cancer, run by Yale University at 1 site in United States.
Trial summary
The purpose of this phase I/II study is to evaluate the safety and clinical activity of Radioiodide (131I-) as a novel targeted therapy for metastatic breast cancer that overexpresses functional Na/I symporter. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Radioiodide (131I-)
- Type of treatment
- 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
- Dec 2016to Jan 2018
- Phase
- Phase 1/2
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Each patient must meet all inclusion criteria in order to be considered for enrollment:
- Histologically confirmed breast cancer with clinical and/or radiological evidence of measurable or evaluable metastatic disease by Response Evaluation in Solid Tumors (RECIST) 1.1.
- Life expectancy ≥12 weeks.
- Radiologic or clinical evidence of disease progression on prior hormonal and/or chemotherapy
- There is no restriction on the number of prior lines of therapy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of < 2.
Show all 16Show fewer
- Full recovery to Grade ≤ 2 from any prior side effects of prior therapy for cancer including radiation therapy, chemotherapy, and/or immunotherapy.
- Adequate bone marrow function defined as white blood cells (WBCs) ≥ 3.0 × 109/L, neutrophils ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L.
- Adequate renal function defined as serum creatinine < 1.5 mg/dL or creatinine clearance (GFR) > 40 mL/min calculated using the following formula: GFR = 175 x Serum Cr-1.154 x age-0.203 x 0.742 (female) and x 1.212 (if patient is African American).
- Adequate liver function defined as AST, ALT ≤ 3 × upper limit of normal (UNL) in the absence of liver metastasis and ≤ 5 × UNL with liver metastases; bilirubin < 1.5 × UNL; alkaline phosphatase ≤ 2.5 × UNL in the absence of liver metastasis and < 5 × UNL in case of bone metastases.
- TSH, T3 and free T4 must be within normal range.
- The patient should not have had intravenous or intrathecal iodinated contrast agents (IVP, CT with contrast, myelogram, angiogram) for 4 weeks prior to screening to their 124I- PET/CT scans and/or 131I- treatment.
- Patients with treated brain metastases are eligible if the brain metastases have remained stable for more than 4 weeks after completing therapy to the brain.
- Normal urine or serum Beta-HCG in premenopausal women of childbearing potential
- Women of childbearing potential must agree to use effective contraception during the treatment period and for at least 6 months after the last dose of 124I- and/or 131I- as these agents interfere with radioactive iodide uptake
- Signed informed consent.
Who cannot join
- Concurrent anti-tumor treatment including radiation therapy, hormonal and chemotherapy.
- Patients with symptomatic cardiac disease such as coronary artery disease, congestive heart failure, or atrial fibrillation.
- Significant gastrointestinal abnormalities, including: ulcerative colitis, chronic diarrhea associated with intestinal malabsorption, Crohn's disease, and prior surgical procedures affecting absorption.
- Women who are nursing or pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Clinical Trial Evaluating the Safety and Clinical Activity of Radioiodide (131I-) as a Novel Targeted Therapy for Metastatic Breast Cancer That Overexpresses Functional Na/I Symporter
The purpose of this phase I/II study is to evaluate the safety and clinical activity of Radioiodide (131I-) as a novel targeted therapy for metastatic breast cancer that overexpresses functional Na/I symporter. The study will enroll patients with metastatic breast cancer who have had clinical and/or radiographic evidence of disease progression on prior hormonal and/or chemotherapy.
Read the detailed description
The primary objectives of the study are as follows:
- To evaluate the feasibility of using 124I- PET/CT scans to identify patients whose metastatic lesions accumulate radioactive iodide and therefore are candidates for 131I- therapy.
- Determine the frequency of iodide (124I) enriching metastatic breast cancer.
- Evaluate the safety and clinical activity of one-time 131I treatment to patients who screen positive on 124I- PET/CT screening, positivity is defined as calculated iodide enrichment that will allow delivering 2000 cGy or more radiation to one or more metastatic lesion by administering up to 200mCi 131I-.
The secondary objectives of the study are as follows:
- To investigate a correlation between NIS expression in tumor tissue with 124I- uptake on screening PET/CT scan
The Phase I portion will follow a 3+3 design with 4 dose levels (30, 60, 120, and 200 mCi) of I- treatment. The maximum tolerated dose will be used in the Phase II efficacy assessment which will follow a Simon's optimal two-stage design. The primary efficacy measure is objective tumor response rate (CR or PR) with targeted activity level of > 20% response rate.
The study will be terminated for futility if no tumor response is seen in the first 12 patients. If futility criteria is not met, a total of 37 eligible patients will be enrolled in the Phase II portion. If 4 or more responses are seen after 37 patients were evaluated, then the investigators will conclude that the regimen warrants further study.
- Conditions
- Breast Cancer
- Being tested
- Radioiodide (131I-)
- Keywords
- Metastatic Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radioiodide (131I-)Radiation
The Phase I portion will follow a 3+3 design with 4 dose levels (30, 60, 120, and 200 mCi) of I- treatment. The maximum tolerated dose (from Phase I) will be used in the Phase II efficacy assessment which will follow a Simon's optimal two-stage design.
| Study group | Role | What they receive |
|---|---|---|
| radioiodide (I-) | Experimental | The Phase I portion will follow a 3+3 design with 4 dose levels (30, 60, 120, and 200 mCi) of I- treatment. The maximum tolerated dose (from Phase I) will be used in the Phase II efficacy assessment which will follow a Simon's optimal two-stage design. Receives: Radiation: Radioiodide (131I-) |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective tumor response rate
The primary efficacy measure is objective tumor response rate (CR or PR) with targeted activity level of > 20% response rate.
Patients should be followed regularly until disease progression and until resolution of all acute toxicities associated with treatment administration. If stable disease or resolution of toxicities takes longer than 24 weeks, follow up frequency will be determined by the treating physician.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJan 2018
- Study completionJan 2018
Why it stopped: The study was withdrawn due to lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Yale 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lajos Pusztai, M.D., D.Phil, Principal investigator, Yale University: Professor of Medicine, Section of Medical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988648
- Sponsor's protocol ID
- 1607018035
- Status last verified
- Aug 2018
- First submitted
- 7 Dec 2016
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Trial Evaluating the Safety and Clinical Activity of Radioiodide (131I-) as a Novel Targeted Therapy for Metastatic Breast Cancer That Overexpresses Functional Na/I Symporter
- ClinicalTrials.gov ID
- NCT02988648
- Acronym / sponsor ID
- 1607018035
- Conditions
- Breast Cancer
- Keywords
- Metastatic Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn due to lack of enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 9 Dec 2016 (estimated)
- 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.
The purpose of this phase I/II study is to evaluate the safety and clinical activity of Radioiodide (131I-) as a novel targeted therapy for metastatic breast cancer that overexpresses functional Na/I symporter. The study will enroll patients with metastatic breast cancer who have had clinical and/or radiographic evidence of disease progression on prior hormonal and/or chemotherapy.
Detailed description
The primary objectives of the study are as follows:
- To evaluate the feasibility of using 124I- PET/CT scans to identify patients whose metastatic lesions accumulate radioactive iodide and therefore are candidates for 131I- therapy.
- Determine the frequency of iodide (124I) enriching metastatic breast cancer.
- Evaluate the safety and clinical activity of one-time 131I treatment to patients who screen positive on 124I- PET/CT screening, positivity is defined as calculated iodide enrichment that will allow delivering 2000 cGy or more radiation to one or more metastatic lesion by administering up to 200mCi 131I-.
The secondary objectives of the study are as follows:
- To investigate a correlation between NIS expression in tumor tissue with 124I- uptake on screening PET/CT scan
The Phase I portion will follow a 3+3 design with 4 dose levels (30, 60, 120, and 200 mCi) of I- treatment. The maximum tolerated dose will be used in the Phase II efficacy assessment which will follow a Simon's optimal two-stage design. The primary efficacy measure is objective tumor response rate (CR or PR) with targeted activity level of > 20% response rate.
The study will be terminated for futility if no tumor response is seen in the first 12 patients. If futility criteria is not met, a total of 37 eligible patients will be enrolled in the Phase II portion. If 4 or more responses are seen after 37 patients were evaluated, then the investigators will conclude that the regimen warrants further study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| radioiodide (I-) | Experimental | Radiation: Radioiodide (131I-)The Phase I portion will follow a 3+3 design with 4 dose levels (30, 60, 120, and 200 mCi) of I- treatment. The maximum tolerated dose (from Phase I) will be used in the Phase II efficacy assessment which will follow a Simon's optimal two-stage design. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically confirmed breast cancer with clinical and/or radiological evidence of measurable or evaluable metastatic disease by Response Evaluation in Solid Tumors (RECIST) 1.1.
- Life expectancy ≥12 weeks.
- Radiologic or clinical evidence of disease progression on prior hormonal and/or chemotherapy
- There is no restriction on the number of prior lines of therapy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of < 2.
Key exclusion criteria (4 listed)
- Concurrent anti-tumor treatment including radiation therapy, hormonal and chemotherapy.
- Patients with symptomatic cardiac disease such as coronary artery disease, congestive heart failure, or atrial fibrillation.
- Significant gastrointestinal abnormalities, including: ulcerative colitis, chronic diarrhea associated with intestinal malabsorption, Crohn's disease, and prior surgical procedures affecting absorption.
- Women who are nursing or pregnant.
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 |
|---|---|---|
| Radioiodide (131I-)The Phase I portion will follow a 3+3 design with 4 dose levels (30, 60, 120, and 200 mCi) of I- treatment. The maximum tolerated dose (from Phase I) will be used in the Phase II efficacy assessment which will follow a Simon's optimal two-stage design. | Radiation | radioiodide (I-) |
Primary outcome
objective tumor response rate
Time frame: Up to 24 weeks
The primary efficacy measure is objective tumor response rate (CR or PR) with targeted activity level of > 20% response rate. Patients should be followed regularly until disease progression and until resolution of all acute toxicities associated with treatment administration. If stable disease or resolution of toxicities takes longer than 24 weeks, follow up frequency will be determined by the treating physician.
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 22 Aug 2018.
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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.
Lajos Pusztai, M.D., D.Phil principal investigator
Yale University: Professor of Medicine, Section of Medical Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Radioiodide (131I-) in people with Breast Cancer, run by Yale 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 16 inclusion and 4 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 22 Aug 2018. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
objective tumor response rate (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2018.