Compare the Efficacy and the Safety of Taxotere and Nanoxel M as Neoadjuvant Chemotherapy in Breast Cancer
NCT ID: NCT05207514
Last Updated: 2024-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
26 participants
INTERVENTIONAL
2022-03-31
2024-05-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Taxotere and Adriamycin/Cytoxan (AC) Validation in Breast Cancer Patients
NCT00206518
Primary Chemotherapy With Adriamycin/Cyclophosphamide(AC) vs Taxotere/Xeloda(TX) for Stage II and III Breast Cancer
NCT00352378
Adjuvant Albumin-bound Paclitaxel Versus Taxanes in Breast Cancer: a Real-world Study
NCT05287308
Docetaxel + Doxorubicin as Neoadjuvant Chemotherapy in Patients With Breast Cancer
NCT00461344
Comparison of Safety and Efficacy of TOCOSOL(R) Paclitaxel Versus Taxol(R) for Treatment of Metastatic Breast Cancer
NCT00251095
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nanoxel M
AC(Doxorubicin, Cyclophosphamide) followed by Nanoxel M
Nanoxel M
75 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide
Doxorubicin
60 mg/m2, intravenously every 3 weeks for 4 cycles. Given as first treatment with cyclophosphamide
Cyclophosphamide
600 mg/m2, intravenously every 3 weeks for 4 cycles. Given as first treatment with doxorubicin.
Taxotere
AC(Doxorubicin, Cyclophosphamide) followed by Taxotere
Taxotere
75 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide
Doxorubicin
60 mg/m2, intravenously every 3 weeks for 4 cycles. Given as first treatment with cyclophosphamide
Cyclophosphamide
600 mg/m2, intravenously every 3 weeks for 4 cycles. Given as first treatment with doxorubicin.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nanoxel M
75 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide
Taxotere
75 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide
Doxorubicin
60 mg/m2, intravenously every 3 weeks for 4 cycles. Given as first treatment with cyclophosphamide
Cyclophosphamide
600 mg/m2, intravenously every 3 weeks for 4 cycles. Given as first treatment with doxorubicin.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients who have been identified as HER2 negative in the tissue obtained through core needle biopsy and have confirmed the positive / negative status of ER (Estrogen receptor) and Progesterone receptor (PR)
* HER2 positive is defined as IHC 3+ or FISH +
3. Patinets whose TNM stage confirmed by CT or MRI (T2-T3, anyN, M0 or T1-3, N1-3, M0)
Exclusion Criteria
2. Patients who have cystitis or urinary obstruction
3. Patients who have history of thromboembolism or coagulation disorder
4. Patients who have Interstitial lung disease ans liver cirrhosis ( \> Child-Pugh class B)
5. Patients who have Insulin-Dependent Type II diabete mellitus
19 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Samyang Biopharmaceuticals Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joohyuk Sohn, M.D.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sevrance Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DPMBC301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.