Sequential vs Upfront Intensified Neoadjuvant Chemotherapy in Patients With Large Resectable or Locally Advanced Breast Cancer.
NCT ID: NCT00314977
Last Updated: 2010-03-18
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
PHASE3
200 participants
INTERVENTIONAL
2006-02-28
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.
Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Docetaxel (AC-Doc) Versus Dose-Dense Doxorubicin and Docetaxel (ADoc) in Breast Cancer
NCT00793377
Phase III Comparison of Adjuvant Chemotherapy W/High-Dose Cyclophosphamide Plus Doxorubicin (AC) vs Sequential Doxorubicin Fol by Cyclophosphamide (A-C) in High Risk Breast Cancer Patients With 0-3 Positive Nodes (Intergroup, CALGB 9394)
NCT00590785
Combination Chemotherapy in Treating Women With Breast Cancer
NCT00003519
Anthracycline-free Taxane Based Chemotherapy in Patients With HER2/Neu Negative Early Breast Cancer
NCT01049425
Combination Chemotherapy in Treating Women With Breast Cancer
NCT00003679
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.
A
Cycles 1-4 q 3 weeks: doxorubicin plus cyclophosphamide Cycles 5-8 q 3 weeks: docetaxel
Doxorubicin
doxorubicin (arm A:60 mg/m2) and arm B: 50 mg/m2)
Cyclophosphamide
Cyclophosphamide: (arm A; 6000 mg/m2) an (arm B: 500 mg/m2)
Docetaxel
Docetaxel: (arm A: 100 mg/m2) and (arm B: 75 mg/m2)
B
Cycles 1-6 q 3 weeks: doxorubicin, cyclophosphamide and docetaxel
Doxorubicin
doxorubicin (arm A:60 mg/m2) and arm B: 50 mg/m2)
Cyclophosphamide
Cyclophosphamide: (arm A; 6000 mg/m2) an (arm B: 500 mg/m2)
Docetaxel
Docetaxel: (arm A: 100 mg/m2) and (arm B: 75 mg/m2)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Doxorubicin
doxorubicin (arm A:60 mg/m2) and arm B: 50 mg/m2)
Cyclophosphamide
Cyclophosphamide: (arm A; 6000 mg/m2) an (arm B: 500 mg/m2)
Docetaxel
Docetaxel: (arm A: 100 mg/m2) and (arm B: 75 mg/m2)
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
* Measurable disease (breast and/or lymph nodes)
* No prior surgery other than biopsy and no prior chemotherapy or radiation therapy
* Age ≥18 years and age ≤70 years
* Karnofsky Performance score ≥70%
* Estrogen and/or progesterone receptor analysis performed on the primary tumour in the biopsy material
* In case the tumor is ER/PgR ³ 50% positive, (neo)adjuvant hormonal therapy in stead of chemotherapy should be considered (e.g. in TEAM II study)
* Her2/neu receptor analysis performed on the primary tumour in the biopsy material
* Adequate bone marrow function (within 14 days prior to registration): WBC ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l
* Adequate liver function (within 4 weeks prior to start treatment): bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL
* Adequate renal function (within 4 weeks prior to start treatment): the calculated creatinine clearance should be ≥50 mL/min
* Patients must be accessible for treatment and follow-up
* Written informed consent according to the local Ethics Committee requirements
Exclusion Criteria
* Serious other diseases as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrythmias
* Evidence of distant metastases (M1)
* Patients with a history of breast cancer
* Patients with a history of another malignancy (except basal cell skin carcinoma and carcinoma-in-situ of the uterine cervix) within 5 years of study entry- Pregnant or lactating women, or potentially fertile women not using adequate contraception
18 Years
70 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Amgen
INDUSTRY
Radboud University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Maastricht University Medical Center
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
V.C.G. Tjan-Heijnen
Role: PRINCIPAL_INVESTIGATOR
AZM Maastricht
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
Rijnstate Ziekenhuis
Arnhem, , Netherlands
Deventer Ziekenhuis
Deventer, , Netherlands
Slingeland Hospital
Doetinchem, , Netherlands
Catharina Ziekenhuis
Eindhoven, , Netherlands
St. Anna Hospital
Geldrop, , Netherlands
St. Jansdal Ziekenhuis
Harderwijk, , Netherlands
Atrium Medisch Centrum
Heerlen, , Netherlands
Elkerliek Ziekenhuis
Helmond, , Netherlands
Spaarne Ziekenhuis
Hoofddorp, , Netherlands
Leids Universitair Medisch Centrum (LUMC)
Leiden, , Netherlands
Academical Hospital Maastricht (AZM)
Maastricht, , Netherlands
St. Antonius Hospital
Nieuwegein, , Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, , Netherlands
Radboud University Medical Centre
Nijmegen, , Netherlands
Waterland Hospital
Purmerend, , Netherlands
Maasland Hospital
Sittard, , Netherlands
HAGA Ziekenhuis
The Hague, , Netherlands
St. Elisabeth Ziekenhuis
Tilburg, , Netherlands
Mesos Medisch Centrum
Utrecht, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
Maxima Medisch Centrum
Veldhoven, , Netherlands
Zaans Medical Centre
Zaandam, , Netherlands
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.
Vriens BEPJ, Vriens IJH, Aarts MJB, van Gastel SM, van den Berkmortel FWPJ, Smilde TJ, van Warmerdam LJC, van Spronsen DJ, Peer PGM, de Boer M, Tjan-Heijnen VCG; Breast Cancer Trialists' Group of the Netherlands (BOOG). Improved survival for sequentially as opposed to concurrently delivered neoadjuvant chemotherapy in non-metastatic breast cancer. Breast Cancer Res Treat. 2017 Oct;165(3):593-600. doi: 10.1007/s10549-017-4364-8. Epub 2017 Jul 3.
Vriens BE, de Vries B, Lobbes MB, van Gastel SM, van den Berkmortel FW, Smilde TJ, van Warmerdam LJ, de Boer M, van Spronsen DJ, Smidt ML, Peer PG, Aarts MJ, Tjan-Heijnen VC; INTENS Study Group. Ultrasound is at least as good as magnetic resonance imaging in predicting tumour size post-neoadjuvant chemotherapy in breast cancer. Eur J Cancer. 2016 Jan;52:67-76. doi: 10.1016/j.ejca.2015.10.010. Epub 2015 Nov 30.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IKO 2005-01 / BOOG 2007-02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.