A Multinational, Multicenter, Open-label, Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of Liporaxel® (Oral Paclitaxel) Compared to Taxol® (IV Paclitaxel) as First-line Therapy in Patients With Recurrent or Metastatic HER2 Negative Breast Cancer
Oral Paclitaxel vs IV Paclitaxel for Breast Cancer
Plain English Summary
Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy is a Phase 3 clinical trial sponsored by Daehwa Pharmaceutical Co., Ltd. studying Recurrent or Metastatic Breast Cancer. Tests the effectiveness and safety of oral paclitaxel compared to IV paclitaxel for treating recurrent or metastatic HER2 negative breast cancer. For patients with recurrent or metastatic breast cancer who have not received prior chemotherapy for metastatic disease and have not taken taxane drugs in the last 12 months. Participation involves taking either oral or IV paclitaxel every 4 weeks until the cancer progresses, side effects are too severe, or the patient withdraws. Alternative treatments include IV paclitaxel and other chemotherapy options. The trial aims to enroll 549 participants.
Official Summary
To compare and evaluate the efficacy and safety of Liporaxel® solution (oral paclitaxel) and Taxol® (IV paclitaxel) on recurrent or metastatic breast cancer.
Who Can Participate
Here is what you need to know about eligibility for this trial. Eligible if you have recurrent or metastatic breast cancer, no prior chemotherapy for metastatic disease, and no taxane drugs in the last 12 months. Not eligible if you have hormone receptor positive breast cancer, central nervous system metastasis, or neuropathy grade 2 or higher. This trial is studying Recurrent or Metastatic Breast Cancer, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcomes measure how well the treatments work and how long patients can go without their cancer getting worse, which is crucial for patients' quality of life. The specific primary outcome measures are: [Phase II] Objective Response Rate (ORR) (Participants will be followed every 6 weeks until progression, an expected average of 9 months.); [Phase III] Progression Free Survival (PFS) (From date of randomization, assessed up to 18 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 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial fills a gap by comparing oral and IV paclitaxel for first-line treatment of recurrent or metastatic breast cancer, offering a potentially more convenient option for patients. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Recurrent or Metastatic Breast Cancer, where improved treatment options are needed.
Investor Insight
The large market size and competitive landscape suggest a high approval probability, making this trial an important step in advancing breast cancer treatment options. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 549 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if you have recurrent or metastatic breast cancer and have not had chemotherapy for metastatic disease in the last 12 months. Participation involves taking either oral or IV paclitaxel every 4 weeks until the cancer progresses, side effects are too severe, or you withdraw. The trial is being conducted at 20 sites. 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: 549 participants
Interventions
- DRUG: Oral paclitaxel — Oral administration on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent
- DRUG: Paclitaxel injection — Premedication, intravenous infusion on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent
Primary Outcomes
- [Phase II] Objective Response Rate (ORR) (Participants will be followed every 6 weeks until progression, an expected average of 9 months.)
- [Phase III] Progression Free Survival (PFS) (From date of randomization, assessed up to 18 months.)
Secondary Outcomes
- [Phase II] Progression Free Survival (PFS) (From date of randomization, assessed up to 18 months.)
- [Phase III] Objective Response Rate (ORR) (Participants will be followed every 6 weeks until progression, an expected average of 9 months.)
- [Phase II&III] Overall Survival(OS) (Until 6 months after the last participant is enrolled, assessed minimum to 18 months.)
- [Phase II&III] Time to Treatment Failure(TTF) (through study completion, an expected average of 4.5 year.)
- [Phase II&III] Disease Control Rate(DCR) (through study completion, an expected average of 4.5 year.)
Full Eligibility Criteria
Key inclusion/exclusion criteria * Histologically or cytologically confirmed to have recurrent, or metastatic breast cancer. * Measurable disease (revised RECIST, version 1.1). * Hormone receptor (ER/PR) positive or negative, HER2 negative. * Subjects were eligible for the study regardless of their previous lines of endocrine therapy. * No prior chemotherapy is allowed in metastatic disease. * Subjects who administrated the last dose of taxane class drug ≥12months ago as from the first administration day. * ECOG performance status ≤1. * Neuropathy grade \<2. * Subjects with central nervous system metastasis should be excluded.
Trial Locations
- Oncology Complex Center - Burgas'' Ltd., Medical Oncology Department, Burgas, Bulgaria
- Multi-profile Hospital for Active Treatment Uni Hospital Ltd. Medical Oncology Department, Panagyurishte, Bulgaria
- Medical Center Nadezhda Clinical" Ltd.,, Sofia, Bulgaria
- Anhui Cancer Hospital, Hefei, Anhui, China
- Cancer Hospital Chinese Academy Of Medical Sciences, Beijing, Beijing Municipality, China
- Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
- The First Affiliated Hospital Of Hainan Medical College, Haikou, Hainan, China
- Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
- Tianjin Cancer Hospital, Zhengzhou, Henan, China
- Jiangsu Cancer Hospital, Nanjing, Jiangsu, China
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT03315364?
NCT03315364 is a Phase 3 INTERVENTIONAL study titled "Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy." It is currently active, not recruiting and is sponsored by Daehwa Pharmaceutical Co., Ltd.. The trial targets enrollment of 549 participants.
What conditions does NCT03315364 study?
This trial investigates treatments for Recurrent or Metastatic Breast Cancer. The primary condition under study is Recurrent or Metastatic Breast Cancer.
What treatments are being tested in NCT03315364?
The interventions being studied include: Oral paclitaxel (DRUG), Paclitaxel injection (DRUG). Oral administration on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent
What does Phase 3 mean for NCT03315364?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT03315364?
This trial is currently "Active, Not Recruiting." It started on 2017-12-18. The estimated completion date is 2028-11-30.
Who is sponsoring NCT03315364?
NCT03315364 is sponsored by Daehwa Pharmaceutical Co., Ltd.. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT03315364?
The trial aims to enroll 549 participants. The trial status is active, not recruiting.
How is NCT03315364 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT03315364?
The primary outcome measures are: [Phase II] Objective Response Rate (ORR) (Participants will be followed every 6 weeks until progression, an expected average of 9 months.); [Phase III] Progression Free Survival (PFS) (From date of randomization, assessed up to 18 months.). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT03315364 being conducted?
This trial is being conducted at 20 sites, including Burgas; Panagyurishte; Sofia; Hefei, Anhui and 16 more sites (Bulgaria, China).
Where can I find official information about NCT03315364?
The official record for NCT03315364 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT03315364. This government database provides the most up-to-date and detailed information about the trial.
What is NCT03315364 testing in simple terms?
Tests the effectiveness and safety of oral paclitaxel compared to IV paclitaxel for treating recurrent or metastatic HER2 negative breast cancer. For patients with recurrent or metastatic breast cancer who have not received prior chemotherapy for metastatic disease and have not taken taxane drugs in the last 12 months.
Why is this trial significant?
This trial fills a gap by comparing oral and IV paclitaxel for first-line treatment of recurrent or metastatic breast cancer, offering a potentially more convenient option for patients. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT03315364?
Key risks include side effects like neuropathy, fatigue, and nausea. Always discuss these with your doctor. Monitor for any changes in your health and report them to your healthcare team. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT03315364?
Ask your doctor if you have recurrent or metastatic breast cancer and have not had chemotherapy for metastatic disease in the last 12 months. Participation involves taking either oral or IV paclitaxel every 4 weeks until the cancer progresses, side effects are too severe, or you withdraw. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT03315364 signal from an investment perspective?
The large market size and competitive landscape suggest a high approval probability, making this trial an important step in advancing breast cancer treatment options. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participation involves taking either oral or IV paclitaxel every 4 weeks until the cancer progresses, side effects are too severe, or the patient withdraws. 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.
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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.