Weekly Paclitaxel Plus Carboplatin in Preoperative Treatment of Breast Cancer
NCT ID: NCT01203267
Last Updated: 2010-09-16
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.
COMPLETED
PHASE2
108 participants
INTERVENTIONAL
2007-12-31
2008-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
paclitaxel plus carboplatin (PCb) Arm
4 cycles of neoadjuvant paclitaxel plus carboplatin
Paclitaxel, Carboplatin
Paclitaxel 80 mg/m2, carboplatin AUC of 2 mg/min/ml, given on days 1, 8 and 15 of a 28-day cycle.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Paclitaxel, Carboplatin
Paclitaxel 80 mg/m2, carboplatin AUC of 2 mg/min/ml, given on days 1, 8 and 15 of a 28-day cycle.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Karnofsky performance status (KPS) ≥ 70
* At least one measurable disease according to the RECIST. histologically confirmed invasive breast cancer (excluding inflammatory breast cancer), large operable (T≥3 cm and N0-1) or locally advanced breast cancer (T3-4N0-3 or T0-4N2-3)
* Biopsy specimens are available for ER, PgR and Her2 analysis
* Adequate bone marrow function: Neutrophil ≥ 1.5\*109/L; Hb ≥ 100g/L; PLT ≥ 100\*109/L
* An estimated life expectancy of at least 12 months
* Willing to take biopsy before neoadjuvant chemotherapy and patients must be accessible for treatment and follow-up
* Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study
* Written informed consent according to the GCP
Exclusion Criteria
* Metastatic breast cancer
* With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma
* Patients with medical conditions that indicate intolerant to neoadjuvant therapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitis, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
* inadequate liver function (bilirubin \> 1.0 times upper normal limit \[UNL\] and ALT and/or AST\> 1.5 UNL associated with alkaline phosphatase \> 2.5 UNL; inadequate renal function (creatinine \> 1.0 times UNL and in case of limit value, Creatinine clearance \< 60 ml/min)
* Contraindication for using dexamethasone
* History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (systolic BP \> 180 mmHg or diastolic BP \> 100 mmHg)
* Has peripheral neuropathy ≥ grade 1
* Patient is pregnant or breast feeding
* Known severe hypersensitivity to any drugs in this study
* Treatment with any investigational drugs within 30 days before the beginning of study treatment
18 Years
70 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fudan University
OTHER
Ruijin Hospital
OTHER
Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Shanghai Jiao Tong University
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kunwei Shen, Dr
Role: PRINCIPAL_INVESTIGATOR
Shanghai Jiao Tong University School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Yang L, Li LD, Chen YD, Parkin DM. [Time trends, estimates and projects for breast cancer incidence and mortality in China]. Zhonghua Zhong Liu Za Zhi. 2006 Jun;28(6):438-40. Chinese.
Rouzier R, Perou CM, Symmans WF, Ibrahim N, Cristofanilli M, Anderson K, Hess KR, Stec J, Ayers M, Wagner P, Morandi P, Fan C, Rabiul I, Ross JS, Hortobagyi GN, Pusztai L. Breast cancer molecular subtypes respond differently to preoperative chemotherapy. Clin Cancer Res. 2005 Aug 15;11(16):5678-85. doi: 10.1158/1078-0432.CCR-04-2421.
Frasci G, Comella P, Rinaldo M, Iodice G, Di Bonito M, D'Aiuto M, Petrillo A, Lastoria S, Siani C, Comella G, D'Aiuto G. Preoperative weekly cisplatin-epirubicin-paclitaxel with G-CSF support in triple-negative large operable breast cancer. Ann Oncol. 2009 Jul;20(7):1185-92. doi: 10.1093/annonc/mdn748. Epub 2009 Feb 13.
Chen XS, Nie XQ, Chen CM, Wu JY, Wu J, Lu JS, Shao ZM, Shen ZZ, Shen KW. Weekly paclitaxel plus carboplatin is an effective nonanthracycline-containing regimen as neoadjuvant chemotherapy for breast cancer. Ann Oncol. 2010 May;21(5):961-7. doi: 10.1093/annonc/mdq041. Epub 2010 Mar 8.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DXK200801
Identifier Type: -
Identifier Source: org_study_id