Sequential vs Upfront Intensified Neoadjuvant Chemotherapy in Patients With Large Resectable or Locally Advanced Breast Cancer.
Overview[ - collapse ][ - ]
Purpose | 2 different treatment schedules may be used for neoadjuvant chemotherapy in breast cancer using adriamycin, cyclophosphamide and taxotere. The most optimal sequence- concurrent or sequential- is however unclear. The aim of the study is to compare the efficacy and tolerability of neoadjuvant chemotherapy with AC followed by T(adriamycin, cyclophosphamide, taxotere) versus TAC ( with upfront T) in patient with large resectable or locally advanced breast cancer. |
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Condition | Breast Cancer |
Intervention | Drug: Doxorubicin Drug: Cyclophosphamide Drug: Docetaxel |
Phase | Phase 3 |
Sponsor | Radboud University |
Responsible Party | Radboud University |
ClinicalTrials.gov Identifier | NCT00314977 |
First Received | April 14, 2006 |
Last Updated | March 17, 2010 |
Last verified | March 2010 |
Tracking Information[ + expand ][ + ]
First Received Date | April 14, 2006 |
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Last Updated Date | March 17, 2010 |
Start Date | February 2006 |
Estimated Primary Completion Date | Not Provided |
Current Primary Outcome Measures | The pathologic complete response rate to neoadjuvant chemotherapy. |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Sequential vs Upfront Intensified Neoadjuvant Chemotherapy in Patients With Large Resectable or Locally Advanced Breast Cancer. |
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Official Title | Sequential vs Upfront Intensified Neoadjuvant Chemotherapy in Patients With Large Resectable and/or Locally Advanced Breast Cancer. The INTENS Study |
Brief Summary | 2 different treatment schedules may be used for neoadjuvant chemotherapy in breast cancer using adriamycin, cyclophosphamide and taxotere. The most optimal sequence- concurrent or sequential- is however unclear. The aim of the study is to compare the efficacy and tolerability of neoadjuvant chemotherapy with AC followed by T(adriamycin, cyclophosphamide, taxotere) versus TAC ( with upfront T) in patient with large resectable or locally advanced breast cancer. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Breast Cancer |
Intervention | Drug: Doxorubicin doxorubicin (arm A:60 mg/m2) and arm B: 50 mg/m2) Other Names:
Cyclophosphamide: (arm A; 6000 mg/m2) an (arm B: 500 mg/m2) Other Names:
Docetaxel: (arm A: 100 mg/m2) and (arm B: 75 mg/m2) Other Names: Taxotere |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 200 |
Estimated Completion Date | Not Provided |
Estimated Primary Completion Date | April 2009 |
Eligibility Criteria | Inclusion Criteria: - Women presenting with large resectable or locally advanced breast cancer (T2 ≥3 cm, T3, or T4, and/or LN positive) - 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: - Patients with advanced pulmonary disease of any cause (oxygen dependent)- Peripheral neuropathy > grade 2 whatever the cause - 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 |
Gender | Female |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Netherlands |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00314977 |
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Other Study ID Numbers | IKO 2005-01 / BOOG 2007-02 |
Has Data Monitoring Committee | No |
Information Provided By | Radboud University |
Study Sponsor | Radboud University |
Collaborators | Sanofi Amgen |
Investigators | Principal Investigator: V.C.G. Tjan-Heijnen AZM Maastricht |
Verification Date | March 2010 |
Locations[ + expand ][ + ]
Onze Lieve Vrouwe Gasthuis | Amsterdam, Netherlands |
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Rijnstate Ziekenhuis | Arnhem, Netherlands |
Jeroen Bosch Ziekenhuis | Den Bosch, Netherlands |
HAGA Ziekenhuis | Den Haag, 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 |
St. Elisabeth Ziekenhuis | Tilburg, Netherlands |
Mesos Medisch Centrum | Utrecht, Netherlands |
UMC Utrecht | Utrecht, Netherlands |
Maxima Medisch Centrum | Veldhoven, Netherlands |
Zaans Medical Centre | Zaandam, Netherlands |