Breast Cancer Early Stage Breast Cancer (Stage 1-3)Phase 3NCT07269691
RaSOLVE: 125I Radioactive Seed Marking Effects on Pathological Complete Response Rate and Prognosis Post-Neoadjuvant Therapy in Early/Advanced Breast Cancer
A Phase 3 study testing Iodine-125 Radioactive Seed Marking and Standard Neoadjuvant Therapy in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3) and Breast Cancer, run by Pengfei Qiu at 1 site in China.
Trial summary
This study is an open-label, controlled, multicenter phase III clinical trial designed to evaluate whether the use of iodine-125 radioactive seed markers can improve treatment response for patients with early or locally advanced breast cancer undergoing neoadjuvant therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer
- What is being tested?
- Iodine-125 Radioactive Seed Marking and Standard Neoadjuvant Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Female patients aged 18 to 70 years.
- ECOG performance status 0-1.
- Pathologically confirmed, previously untreated, unilateral primary invasive breast cancer.
- Clinical stage cT1cN1-2M0 or cT2-3N0-2M0 (AJCC 8th edition).
- Adequate organ function within 7 days prior to randomization:
- Hemoglobin ≥ 90 g/L
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- ANC ≥ 1.5×10⁹/L; Lymphocyte count ≥ 0.5×10⁹/L
- Platelet count ≥ 100×10⁹/L
- WBC 3.0-15×10⁹/L
- ALT, AST ≤ 2.5×ULN; ALP ≤ 2.5×ULN; TBIL ≤ 1.5×ULN
- Serum creatinine ≤ 1.5×ULN and creatinine clearance ≥ 60 mL/min
- PT, APTT ≤ 1.5×ULN
- Urine protein < 2+ or 24-hour urine protein ≤ 1 g
- LVEF ≥ 55%
- QTcF < 470 ms
- Negative serum pregnancy test within 3 days prior to first treatment for women of childbearing potential and agreement to use effective contraception.
- Willing and able to sign informed consent.
Who cannot join
- Bilateral breast cancer or history of DCIS, LCIS, invasive breast cancer, or metastatic breast cancer.
- Any malignancy diagnosed within the past 5 years except cured cervical carcinoma in situ or non-melanoma skin cancer.
- Prior systemic chemotherapy, targeted therapy, immunotherapy, or radiotherapy within 1 year.
- Prior exposure to anthracyclines, taxanes, or platinum agents.
- Primary or secondary immunodeficiency; uncontrolled autoimmune disease (except controlled hypothyroidism or type 1 diabetes).
- Interstitial lung disease or severe chronic lung disease.
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- Clinically significant cardiovascular disease, including:
- NYHA class ≥ III
- Myocardial infarction or stroke within 3 months
- Uncontrolled hypertension
- Clinically significant arrhythmia or heart failure
- Arterial/venous thrombosis within 3 months.
- Vaccination with live attenuated vaccine within 28 days.
- Active HBV, HCV, or HIV infection.
- Major surgery within 28 days (except diagnostic procedures).
- Severe infection within 4 weeks or systemic antibiotic-treated infection within 2 weeks.
- History of bone marrow or organ transplantation.
- Coagulation abnormalities (INR > 1.5 or APTT > 1.5×ULN).
- Peripheral neuropathy ≥ Grade 2.
- Treatment with systemic immunostimulatory agents within 4 weeks or immunosuppressive agents within 2 weeks.
- Known allergy to study agents.
- Participation in another clinical trial within 4 weeks.
- Pregnancy, breastfeeding, or planning pregnancy.
- Substance abuse or psychiatric conditions that may affect compliance.
- Any condition that, in the investigator's judgment, makes the patient unsuitable for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shandong Cancer Hospital affiliated to Shandong First Medical University
Jinan, Shandong, 250117
Pengfei Qiu MD, +86-26215, qiupengfei2002@126.com
About this study
Official title: RaSOLVE: An Open-Label, Controlled, Randomized, Multicenter Phase III Clinical Trial Assessing the Impact of Preoperative 125I Radioactive Seed Localization on Pathological Complete Response Rate (tpCR: ypT0/is ypN0) and Long-Term Prognosis (iDFS/OS) in Women With Early or Locally Advanced Newly Diagnosed Untreated Breast Cancer Following Neoadjuvant Therapy
This study is an open-label, controlled, multicenter phase III clinical trial designed to evaluate whether the use of iodine-125 radioactive seed markers can improve treatment response for patients with early or locally advanced breast cancer undergoing neoadjuvant therapy.
Neoadjuvant therapy is widely used for breast cancer to shrink tumors, increase the chances of breast-conserving surgery, and help determine the most effective postoperative treatments. Achieving a pathological complete response (pCR) after neoadjuvant therapy is strongly associated with better long-term outcomes.
Read more
In this study, qualified participants will be randomly assigned in a 1:1 ratio to either the experimental group or the control group.
Experimental group: Patients will receive placement of iodine-125 seed markers in the primary breast tumor and biopsy-proven positive axillary lymph nodes before starting neoadjuvant therapy.
Control group: Patients will undergo standard neoadjuvant therapy without seed placement.
All participants will then complete neoadjuvant therapy followed by surgery. Pathological evaluation will determine whether the cancer has completely disappeared. Long-term outcomes, including invasive disease-free survival, will be followed for at least five years.
The goal of this study is to determine whether radioactive seed marking can increase the rate of pathological complete response and improve prognosis in patients receiving neoadjuvant therapy for breast cancer. The study will also explore whether iodine-125 seeds may activate immune responses that contribute to treatment effectiveness.
Read the detailed description
This multicenter, open-label, controlled phase III clinical trial aims to investigate the clinical value of iodine-125 radioactive seed markers in patients with early or locally advanced breast cancer undergoing neoadjuvant therapy. Current guidelines support pre-treatment marking of primary tumors and lymph nodes to improve surgical accuracy and reduce false-negative rates in sentinel lymph node biopsy after neoadjuvant therapy. However, the optimal marking method remains unclear. Iodine-125 seeds offer potential advantages, including high localization accuracy, improved identification of metastatic lymph nodes, and favorable cost-effectiveness compared with other wireless or metallic markers.
Eligible patients will be randomized 1:1 into either the experimental or control group.
Experimental group: Under ultrasound guidance, iodine-125 seeds (0.1-0.3 mCi) will be implanted into the primary breast tumor and biopsy-proven positive axillary lymph nodes before the first cycle of neoadjuvant therapy. Seed positions will be monitored throughout therapy by ultrasound, mammography, and MRI to confirm they have not migrated (defined as ≤5 mm deviation from baseline).
Control group: Patients will receive neoadjuvant therapy without seed implantation.
All participants will receive standard neoadjuvant systemic therapy according to disease subtype and investigator assessment. Following therapy, participants will undergo surgery, and pathological responses will be evaluated by predefined criteria. Patients will be followed for at least five years to assess invasive disease-free survival and other outcomes.
Objectives and Endpoints
The primary objective is to compare the pathological complete response (pCR) rate between the seed-marked arm and the control arm. pCR is defined as ypT0/is and ypN0, meaning no residual invasive carcinoma in the breast or regional lymph nodes.
Secondary objectives include breast pCR (bpCR), axillary pCR (apCR), and invasive disease-free survival (iDFS). An exploratory endpoint will evaluate whether iodine-125 seeds may stimulate immune activation by monitoring peripheral blood CD4+/CD8+ T-cell ratios during treatment.
Study Rationale
Neoadjuvant therapy plays a critical role in downstaging tumors and improving surgical options. Achieving pCR is associated with significantly improved long-term survival outcomes, particularly for HER2-positive and triple-negative breast cancer. Our preliminary work suggests that patients receiving iodine-125 seed implantation prior to neoadjuvant therapy show improved pCR rates across molecular subtypes compared with patients without seed placement. Therefore, this trial aims to confirm the effectiveness and safety of radioactive seed marking in a rigorously controlled phase III study and to explore its biological mechanisms.
Safety Monitoring
Adverse events and serious adverse events will be recorded from the time informed consent is obtained until postoperative follow-up. All safety assessments, including laboratory tests, imaging, and clinical examinations, will be performed according to protocol-defined schedules. The relationship between adverse events and seed implantation will be evaluated by investigators following prespecified criteria.
This trial is expected to provide high-quality evidence regarding the clinical utility of iodine-125 seeds in improving response assessment, enhancing pCR rates, and potentially affecting long-term prognosis in breast cancer patients receiving neoadjuvant therapy. It may also contribute novel insights into radiotherapy-related immunomodulatory mechanisms.
- Being tested
- Iodine-125 Radioactive Seed Marking, Standard Neoadjuvant Therapy
- Keywords
- Iodine-125 seed Radioactive seed marking Breast cancer Neoadjuvant therapy Pathological complete response
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodine-125 Radioactive Seed MarkingDevice
Ultrasound-guided implantation of iodine-125 radioactive seeds (0.1-0.3 mCi) into the primary breast tumor and biopsy-confirmed positive axillary lymph nodes prior to the first cycle of neoadjuvant therapy. Seed position will be verified during treatment using ultrasound, mammography, and MRI.
Arm(s) Applied to：
Standard Neoadjuvant TherapyDrug
Systemic neoadjuvant therapy based on breast cancer subtype and clinical guidelines, which may include chemotherapy, targeted therapy, immunotherapy, or endocrine therapy as assessed by investigators. All participants in both arms will receive neoadjuvant therapy followed by surgery.
| Study group | Role | What they receive |
|---|---|---|
| Iodine-125 Seed Marking | Experimental | Participants in this arm will undergo ultrasound-guided implantation of Iodine-125 radioactive seeds (0.1-0.3 mCi) into the primary breast tumor and biopsy-confirmed metastatic axillary lymph nodes before starting neoadjuvant therapy. Seed position will be monitored every two cycles using ultrasound and confirmed preoperatively by mammography and MRI. After implantation, all participants will receive standard neoadjuvant therapy followed by surgery and pathological assessment according to study protocol. Receives: Device: Iodine-125 Radioactive Seed Marking; Drug: Standard Neoadjuvant Therapy |
| No Seed Marking | Active comparator | Participants in this arm will receive standard neoadjuvant therapy without implantation of iodine-125 seeds. After neoadjuvant therapy is completed, participants will undergo surgery and pathological evaluation according to standard clinical practice. Receives: Drug: Standard Neoadjuvant Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response (pCR)
Pathologic complete response (pCR) is defined as no residual invasive carcinoma in both the resected breast tissue and ipsilateral regional lymph nodes following completion of neoadjuvant therapy and surgery (ypT0/is, ypN0). Residual ductal carcinoma in situ (DCIS) may be present. This definition is fully consistent with the study protocol.
Measured: At the time of surgery, approximately 6-8 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized 1:1 to the iodine-125 seed marking group or the control group.
- Masking
- None (open label)
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pengfei Qiu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pengfei Qiu, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269691
- Sponsor's protocol ID
- SDZLEC2025-477-01
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the dataset contains sensitive clinical information and is subject to institutional and regulatory restrictions in China. Data sharing is not planned due to privacy protection requirements and limitations in the current data management framework.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RaSOLVE: An Open-Label, Controlled, Randomized, Multicenter Phase III Clinical Trial Assessing the Impact of Preoperative 125I Radioactive Seed Localization on Pathological Complete Response Rate (tpCR: ypT0/is ypN0) and Long-Term Prognosis (iDFS/OS) in Women With Early or Locally Advanced Newly Diagnosed Untreated Breast Cancer Following Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT07269691
- Acronym / sponsor ID
- SDZLEC2025-477-01
- Keywords
- Iodine-125 seed Radioactive seed marking Breast cancer Neoadjuvant therapy Pathological complete response
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Pengfei QiuUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 8 Dec 2025 (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 study is an open-label, controlled, multicenter phase III clinical trial designed to evaluate whether the use of iodine-125 radioactive seed markers can improve treatment response for patients with early or locally advanced breast cancer undergoing neoadjuvant therapy.
Neoadjuvant therapy is widely used for breast cancer to shrink tumors, increase the chances of breast-conserving surgery, and help determine the most effective postoperative treatments. Achieving a pathological complete response (pCR) after neoadjuvant therapy is strongly associated with better long-term outcomes.
In this study, qualified participants will be randomly assigned in a 1:1 ratio to either the experimental group or the control group.
Experimental group: Patients will receive placement of iodine-125 seed markers in the primary breast tumor and biopsy-proven positive axillary lymph nodes before starting neoadjuvant therapy.
Control group: Patients will undergo standard neoadjuvant therapy without seed placement.
All participants will then complete neoadjuvant therapy followed by surgery. Pathological evaluation will determine whether the cancer has completely disappeared. Long-term outcomes, including invasive disease-free survival, will be followed for at least five years.
The goal of this study is to determine whether radioactive seed marking can increase the rate of pathological complete response and improve prognosis in patients receiving neoadjuvant therapy for breast cancer. The study will also explore whether iodine-125 seeds may activate immune responses that contribute to treatment effectiveness.
Detailed description
This multicenter, open-label, controlled phase III clinical trial aims to investigate the clinical value of iodine-125 radioactive seed markers in patients with early or locally advanced breast cancer undergoing neoadjuvant therapy. Current guidelines support pre-treatment marking of primary tumors and lymph nodes to improve surgical accuracy and reduce false-negative rates in sentinel lymph node biopsy after neoadjuvant therapy. However, the optimal marking method remains unclear. Iodine-125 seeds offer potential advantages, including high localization accuracy, improved identification of metastatic lymph nodes, and favorable cost-effectiveness compared with other wireless or metallic markers.
Eligible patients will be randomized 1:1 into either the experimental or control group.
Experimental group: Under ultrasound guidance, iodine-125 seeds (0.1-0.3 mCi) will be implanted into the primary breast tumor and biopsy-proven positive axillary lymph nodes before the first cycle of neoadjuvant therapy. Seed positions will be monitored throughout therapy by ultrasound, mammography, and MRI to confirm they have not migrated (defined as ≤5 mm deviation from baseline).
Control group: Patients will receive neoadjuvant therapy without seed implantation.
All participants will receive standard neoadjuvant systemic therapy according to disease subtype and investigator assessment. Following therapy, participants will undergo surgery, and pathological responses will be evaluated by predefined criteria. Patients will be followed for at least five years to assess invasive disease-free survival and other outcomes.
Objectives and Endpoints
The primary objective is to compare the pathological complete response (pCR) rate between the seed-marked arm and the control arm. pCR is defined as ypT0/is and ypN0, meaning no residual invasive carcinoma in the breast or regional lymph nodes.
Secondary objectives include breast pCR (bpCR), axillary pCR (apCR), and invasive disease-free survival (iDFS). An exploratory endpoint will evaluate whether iodine-125 seeds may stimulate immune activation by monitoring peripheral blood CD4+/CD8+ T-cell ratios during treatment.
Study Rationale
Neoadjuvant therapy plays a critical role in downstaging tumors and improving surgical options. Achieving pCR is associated with significantly improved long-term survival outcomes, particularly for HER2-positive and triple-negative breast cancer. Our preliminary work suggests that patients receiving iodine-125 seed implantation prior to neoadjuvant therapy show improved pCR rates across molecular subtypes compared with patients without seed placement. Therefore, this trial aims to confirm the effectiveness and safety of radioactive seed marking in a rigorously controlled phase III study and to explore its biological mechanisms.
Safety Monitoring
Adverse events and serious adverse events will be recorded from the time informed consent is obtained until postoperative follow-up. All safety assessments, including laboratory tests, imaging, and clinical examinations, will be performed according to protocol-defined schedules. The relationship between adverse events and seed implantation will be evaluated by investigators following prespecified criteria.
This trial is expected to provide high-quality evidence regarding the clinical utility of iodine-125 seeds in improving response assessment, enhancing pCR rates, and potentially affecting long-term prognosis in breast cancer patients receiving neoadjuvant therapy. It may also contribute novel insights into radiotherapy-related immunomodulatory mechanisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized 1:1 to the iodine-125 seed marking group or the control group.
| Arm | Type | Receives |
|---|---|---|
| Iodine-125 Seed Marking | Experimental | Device: Iodine-125 Radioactive Seed Marking, Drug: Standard Neoadjuvant TherapyParticipants in this arm will undergo ultrasound-guided implantation of Iodine-125 radioactive seeds (0.1-0.3 mCi) into the primary breast tumor and biopsy-confirmed metastatic axillary lymph nodes before starting neoadjuvant therapy. Seed position will be monitored every two cycles using ultrasound and confirmed preoperatively by mammography and MRI. After implantation, all participants will receive standard neoadjuvant therapy followed by surgery and pathological assessment according to study protocol. |
| No Seed Marking | Active comparator | Drug: Standard Neoadjuvant TherapyParticipants in this arm will receive standard neoadjuvant therapy without implantation of iodine-125 seeds. After neoadjuvant therapy is completed, participants will undergo surgery and pathological evaluation according to standard clinical practice. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Female patients aged 18 to 70 years.
- ECOG performance status 0-1.
- Pathologically confirmed, previously untreated, unilateral primary invasive breast cancer.
- Clinical stage cT1cN1-2M0 or cT2-3N0-2M0 (AJCC 8th edition).
- Adequate organ function within 7 days prior to randomization:
Key exclusion criteria (25 listed)
- Bilateral breast cancer or history of DCIS, LCIS, invasive breast cancer, or metastatic breast cancer.
- Any malignancy diagnosed within the past 5 years except cured cervical carcinoma in situ or non-melanoma skin cancer.
- Prior systemic chemotherapy, targeted therapy, immunotherapy, or radiotherapy within 1 year.
- Prior exposure to anthracyclines, taxanes, or platinum agents.
- Primary or secondary immunodeficiency; uncontrolled autoimmune disease (except controlled hypothyroidism or type 1 diabetes).
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 |
|---|---|---|
| Iodine-125 Radioactive Seed MarkingUltrasound-guided implantation of iodine-125 radioactive seeds (0.1-0.3 mCi) into the primary breast tumor and biopsy-confirmed positive axillary lymph nodes prior to the first cycle of neoadjuvant therapy. Seed position will be verified during treatment using ultrasound, mammography, and MRI. Arm(s) Applied to： | Device | Iodine-125 Seed Marking |
| Standard Neoadjuvant TherapySystemic neoadjuvant therapy based on breast cancer subtype and clinical guidelines, which may include chemotherapy, targeted therapy, immunotherapy, or endocrine therapy as assessed by investigators. All participants in both arms will receive neoadjuvant therapy followed by surgery. | Drug | Iodine-125 Seed Marking, No Seed Marking |
Primary outcome
Pathologic Complete Response (pCR)
Time frame: At the time of surgery, approximately 6-8 months after enrollment
Pathologic complete response (pCR) is defined as no residual invasive carcinoma in both the resected breast tissue and ipsilateral regional lymph nodes following completion of neoadjuvant therapy and surgery (ypT0/is, ypN0). Residual ductal carcinoma in situ (DCIS) may be present. This definition is fully consistent with the study protocol.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the dataset contains sensitive clinical information and is subject to institutional and regulatory restrictions in China. Data sharing is not planned due to privacy protection requirements and limitations in the current data management framework.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Iodine-125 Radioactive Seed Marking and Standard Neoadjuvant Therapy in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3) and Breast Cancer, run by Pengfei Qiu at 1 site in China.
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 17 inclusion and 25 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: opening soon, as of the sponsor's last update on 8 Dec 2025. 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pengfei Qiu MD (+86-26215, qiupengfei2002@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response (pCR) (time frame: At the time of surgery, approximately 6-8 months after enrollment). 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 8 Dec 2025.