Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer Following Neoadjuvant Chemotherapy and Surgery
New trial screens for hidden breast cancer spread after treatment
Plain English Summary
Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer is a Phase 2 clinical trial sponsored by H. Lee Moffitt Cancer Center and Research Institute studying Breast Cancer, Node-positive Breast Cancer. This trial tests how well CT scans can find if breast cancer has spread to other parts of the body after initial treatment. It is for patients with node-positive breast cancer who have finished chemotherapy and surgery. Participation involves CT scans of the chest, abdomen, and pelvis at the start and potentially again at 6 months. Standard follow-up care and imaging are the current alternatives. The trial aims to enroll 120 participants.
Official Summary
The purpose of the study is to determine the frequency of systemic metastasis in node positive breast cancer following chemotherapy and surgery. Participants will be asked to spend about 6 months in this study. Participants will undergo a computed tomography (CT) screening of the thorax, abdomen, and pelvis at baseline prior to adjuvant radiation therapy and another CT screening of the thorax, abdomen, and pelvis at 6 months if the baseline CT is found to be negative.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with node-positive breast cancer (HER2+ or triple-negative, or HR+/HER2- with specific node involvement) who have completed chemotherapy and surgery can join. Patients with a history of cancer spread (metastasis) or certain other cancers may not be eligible. You must be 18 or older, have at least 6 months life expectancy, and be able to undergo CT scans. Good general health and the ability to comply with study procedures are required. This trial is studying Breast Cancer, Node-positive Breast Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how often CT scans detect cancer that has spread to distant parts of the body, helping doctors understand the risk of recurrence. The specific primary outcome measures are: Systemic Metastasis (Baseline and 6 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial aims to improve early detection of cancer spread, which is crucial for timely and effective treatment decisions in breast cancer patients. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Breast Cancer, Node-positive Breast Cancer, where improved treatment options are needed.
Investor Insight
This study addresses a critical need for better systemic screening in a significant breast cancer subgroup, potentially improving patient outcomes and impacting future diagnostic guidelines. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor about the specific CT scan procedures and what to expect. Understand that participation involves undergoing CT scans and potentially additional follow-up based on results. Be prepared for the time commitment of approximately 6 months for the study's core screening period. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NON_RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 120 participants
Interventions
- OTHER: CT Scan — Participants will undergo a screening CT thorax, abdomen, pelvis at baseline prior to adjuvant radiation therapy and additional screening CT thorax, abdomen, and pelvis at 6 months if the baseline CT is found to be negative.
Primary Outcomes
- Systemic Metastasis (Baseline and 6 months)
Secondary Outcomes
- Metastasis Treatment (Up to 12 months)
- Metastasis Frequency (Up to 12 months)
Full Eligibility Criteria
Inclusion Criteria: * Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status. * HR+ will be defined as ER and/or PR ≥ 10%. To be classified as HER2+ disease, overexpression of HER2 by either IHC or in-situ hybridization is necessary as defined by the ASCO / CAP Guidelines27. Triple negative will be classified as ER and PR \<10% and HER2-. * Node positive HER2+ and triple negative breast cancer (ypN+) following receipt of neoadjuvant chemotherapy. HR+/HER2- patients should have ypN2 or ypN3 disease following receipt of neoadjuvant chemotherapy and surgery. * Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen. To include HER2 directed therapy for HER2+ patients. * Age ≥ 18. * Life expectancy ≥ 6 months. * Eastern Cooperative Oncology Group performance status 0 to 2. * Patients must be able to understand and the willingness to sign an informed consent for study procedures. * Ability to understand and stated willingness to comply with all study procedures and availability for the duration of the study. Exclusion Criteria: * Prior diagnosis of systemic metastases. * Patients with prior history of non-breast cancer malignancies should have NED ≥ 2 years excluding adequately treated non-melanoma skin cancer, in situ cancer of the cervix or bladder. * Contraindication towards CT IV contrast. * Chronic kidney disease stage IV or V or end stage renal disease (CrCl \<30 ml/min).
Trial Locations
- Moffitt Cancer Center, Tampa, Florida, United States
Frequently Asked Questions
What is clinical trial NCT06833502?
NCT06833502 is a Phase 2 INTERVENTIONAL study titled "Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer." It is currently recruiting and is sponsored by H. Lee Moffitt Cancer Center and Research Institute. The trial targets enrollment of 120 participants.
What conditions does NCT06833502 study?
This trial investigates treatments for Breast Cancer, Node-positive Breast Cancer. The primary condition under study is Breast Cancer.
What treatments are being tested in NCT06833502?
The interventions being studied include: CT Scan (OTHER). Participants will undergo a screening CT thorax, abdomen, pelvis at baseline prior to adjuvant radiation therapy and additional screening CT thorax, abdomen, and pelvis at 6 months if the baseline CT is found to be negative.
What does Phase 2 mean for NCT06833502?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT06833502?
This trial is currently "Recruiting." It started on 2025-02-24. The estimated completion date is 2026-10.
Who is sponsoring NCT06833502?
NCT06833502 is sponsored by H. Lee Moffitt Cancer Center and Research Institute. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06833502?
The trial aims to enroll 120 participants. The trial is currently recruiting and accepting new participants.
How is NCT06833502 designed?
This is a interventional study, uses non_randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT06833502?
The primary outcome measures are: Systemic Metastasis (Baseline and 6 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06833502 being conducted?
This trial is being conducted at 1 site, including Tampa, Florida (United States).
Where can I find official information about NCT06833502?
The official record for NCT06833502 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06833502. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06833502 testing in simple terms?
This trial tests how well CT scans can find if breast cancer has spread to other parts of the body after initial treatment. It is for patients with node-positive breast cancer who have finished chemotherapy and surgery.
Why is this trial significant?
This trial aims to improve early detection of cancer spread, which is crucial for timely and effective treatment decisions in breast cancer patients.
What are the potential risks of participating in NCT06833502?
Risks associated with CT scans include radiation exposure and potential allergic reactions to contrast dye. There is a small chance of false positive results, leading to unnecessary anxiety or further testing. The scans may detect other medical conditions unrelated to breast cancer. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06833502?
Ask your doctor about the specific CT scan procedures and what to expect. Understand that participation involves undergoing CT scans and potentially additional follow-up based on results. Be prepared for the time commitment of approximately 6 months for the study's core screening period. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06833502 signal from an investment perspective?
This study addresses a critical need for better systemic screening in a significant breast cancer subgroup, potentially improving patient outcomes and impacting future diagnostic guidelines. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participation involves CT scans of the chest, abdomen, and pelvis at the start and potentially again at 6 months. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.