A Randomized, Multicenter, Open-label Clinical Study Using Peripheral Blood Circulating Tumor DNA to Evaluate the Efficacy of Preoperative Treatment With Pyrotinib + Trastuzumab + Docetaxel Versus Pertuzumab + Trastuzumab + Docetaxel in Early or Locally Advanced HER2-positive Breast Cancer
New Trial Tests Chemo Combinations for HER2+ Breast Cancer Using Blood Tests
Plain English Summary
ctDNA in HER2+ EBC Neoadjuvant Treatment is a Phase 2 clinical trial sponsored by Shanghai Jiao Tong University School of Medicine studying Breast Cancer. This trial compares two different chemotherapy combinations given before surgery for HER2-positive breast cancer. It is for patients with early or locally advanced HER2-positive breast cancer. Participation involves receiving one of the two treatment regimens and having blood drawn to measure circulating tumor DNA (ctDNA). Standard treatment options for this condition include surgery, chemotherapy, radiation, and targeted therapies. The trial aims to enroll 60 participants.
Official Summary
This study is a randomized, open-label, multicenter clinical study for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer, aiming to compare the peripheral blood ctDNA clearance of neoadjuvant pyrotinib + trastuzumab + docetaxel and pertuzumab + trastuzumab + docetaxel for one course and to evaluate the therapeutic effectiveness of four courses of neoadjuvant therapy
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with HER2-positive breast cancer that is early stage or locally advanced (tumor larger than 2cm) can join. Patients must have good general health, with normal kidney, liver, bone marrow, and heart function. Individuals who have had prior cancer treatment or have other serious health conditions may not be eligible. The trial is for adults. This trial is studying 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 well the cancer cells in the blood disappear after the first round of treatment, indicating how effectively the therapy is working early on. The specific primary outcome measures are: ctDNA clearance after one cycle neoadjuvant treatment (3 months after neoadjuvant treatment initation). 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 find a potentially more effective way to treat HER2-positive breast cancer before surgery by monitoring treatment response through a simple blood test, addressing the need for perso Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Breast Cancer, where improved treatment options are needed.
Investor Insight
This trial explores novel chemotherapy combinations for a significant subset of breast cancer patients, potentially leading to improved treatment outcomes and offering a competitive edge in the target Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if this trial is a good fit for you, considering your specific cancer type and overall health. You will receive one of two pre-surgery chemotherapy regimens, and regular blood tests will be performed to monitor treatment effectiveness. The study involves treatment over several months, followed by surgery and potentially further treatment. 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: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 60 participants
Interventions
- DRUG: pyrotinib — pyrotinib 320mg p.o. qd
- DRUG: pertuzumab — pertuzumab ivgtt q3w, 840mg for initiation, 420mg for maintenance
- DRUG: trastuzumab — trastuzumab ivgtt q3w, 8mg/kg for initiation, 6mg/kg for maintenance
- DRUG: docetaxel — docetaxel ivgtt q3w, 80-100mg/m2
Primary Outcomes
- ctDNA clearance after one cycle neoadjuvant treatment (3 months after neoadjuvant treatment initation)
Secondary Outcomes
- ctDNA clearance after two cycle neoadjuvant treatment (3 months after neoadjuvant treatment initation)
- pCR rate (6 months after neoadjuvant treatment initation)
- bpCR rate (6 months after neoadjuvant treatment initation)
- ORR (6 months after neoadjuvant treatment initation)
- EFS (2 years after surgery)
Full Eligibility Criteria
Inclusion Criteria: * histologically diagnosed with Stage II-III HER2+ breast cancer (primary diameter \>2cm) * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Intact renal, hepatic, bone marrow and cardiac functions including baseline left ventricular ejection fraction (LVEF) ≥ 55% measured by echocardiography * No prior treatment Exclusion Criteria: * Bilateral or metastatic breast cancer * History of other malignancies * Severe cardiovascular disease * Allergic to any of the regimens
Trial Locations
- Ruijin Hospital, Shanghai, China
Frequently Asked Questions
What is clinical trial NCT07335081?
NCT07335081 is a Phase 2 INTERVENTIONAL study titled "ctDNA in HER2+ EBC Neoadjuvant Treatment." It is currently recruiting and is sponsored by Shanghai Jiao Tong University School of Medicine. The trial targets enrollment of 60 participants.
What conditions does NCT07335081 study?
This trial investigates treatments for Breast Cancer. The primary condition under study is Breast Cancer.
What treatments are being tested in NCT07335081?
The interventions being studied include: pyrotinib (DRUG), pertuzumab (DRUG), trastuzumab (DRUG), docetaxel (DRUG). pyrotinib 320mg p.o. qd
What does Phase 2 mean for NCT07335081?
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 NCT07335081?
This trial is currently "Recruiting." It started on 2024-02-01. The estimated completion date is 2026-12-31.
Who is sponsoring NCT07335081?
NCT07335081 is sponsored by Shanghai Jiao Tong University School of Medicine. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07335081?
The trial aims to enroll 60 participants. The trial is currently recruiting and accepting new participants.
How is NCT07335081 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07335081?
The primary outcome measures are: ctDNA clearance after one cycle neoadjuvant treatment (3 months after neoadjuvant treatment initation). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07335081 being conducted?
This trial is being conducted at 1 site, including Shanghai (China).
Where can I find official information about NCT07335081?
The official record for NCT07335081 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07335081. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07335081 testing in simple terms?
This trial compares two different chemotherapy combinations given before surgery for HER2-positive breast cancer. It is for patients with early or locally advanced HER2-positive breast cancer.
Why is this trial significant?
This trial aims to find a potentially more effective way to treat HER2-positive breast cancer before surgery by monitoring treatment response through a simple blood test, addressing the need for perso
What are the potential risks of participating in NCT07335081?
Common side effects of chemotherapy can include fatigue, nausea, hair loss, and a higher risk of infection. Specific risks associated with these drugs may include heart problems, nerve damage, and allergic reactions. The study is open-label, meaning both you and your doctor will know which treatment you are receiving, which could introduce bias. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07335081?
Ask your doctor if this trial is a good fit for you, considering your specific cancer type and overall health. You will receive one of two pre-surgery chemotherapy regimens, and regular blood tests will be performed to monitor treatment effectiveness. The study involves treatment over several months, followed by surgery and potentially further treatment. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07335081 signal from an investment perspective?
This trial explores novel chemotherapy combinations for a significant subset of breast cancer patients, potentially leading to improved treatment outcomes and offering a competitive edge in the target 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 receiving one of the two treatment regimens and having blood drawn to measure circulating tumor DNA (ctDNA). 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.