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INTENS: Sequential vs Upfront Intensified Neoadjuvant Chemotherapy in Patients With Large Resectable or Locally Advanced Breast Cancer.

Sponsor
Radboud University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00314977
Collaborator
Sanofi (Industry), Amgen (Industry)
200
Enrollment
24
Locations
2
Arms
8.3
Patients Per Site

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Sequential vs Upfront Intensified Neoadjuvant Chemotherapy in Patients With Large Resectable and/or Locally Advanced Breast Cancer. The INTENS Study
Study Start Date :
Feb 1, 2006
Actual Primary Completion Date :
Apr 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Cycles 1-4 q 3 weeks: doxorubicin plus cyclophosphamide Cycles 5-8 q 3 weeks: docetaxel

Drug: Doxorubicin
doxorubicin (arm A:60 mg/m2) and arm B: 50 mg/m2)
Other Names:
  • hydroxyldaunorubicin
  • adriamycin

    • Drug: Cyclophosphamide
    Cyclophosphamide: (arm A; 6000 mg/m2) an (arm B: 500 mg/m2)
    Other Names:
  • Cytoxan
  • Neosar
  • Revimmune

    • Drug: Docetaxel
    Docetaxel: (arm A: 100 mg/m2) and (arm B: 75 mg/m2)
    Other Names:
  • Taxotere

    		•
    Experimental: B

    Cycles 1-6 q 3 weeks: doxorubicin, cyclophosphamide and docetaxel

    Drug: Doxorubicin
    doxorubicin (arm A:60 mg/m2) and arm B: 50 mg/m2)
    Other Names:
  • hydroxyldaunorubicin
  • adriamycin

    • Drug: Cyclophosphamide
    Cyclophosphamide: (arm A; 6000 mg/m2) an (arm B: 500 mg/m2)
    Other Names:
  • Cytoxan
  • Neosar
  • Revimmune

    • Drug: Docetaxel
    Docetaxel: (arm A: 100 mg/m2) and (arm B: 75 mg/m2)
    Other Names:
  • Taxotere

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The pathologic complete response rate to neoadjuvant chemotherapy. []

    Secondary Outcome Measures

    1. The delivered chemotherapy dose and dose-intensity of both chemotherapy regimens []

    2. The tolerability (grade 3/4 CTC toxicities) of both chemotherapy regimens. []

    3. The clinical responses of neoadjuvant chemotherapy correlated to pathological responses after neoadjuvant chemotherapy. []

    4. The value of breast MRI in evaluating response to neoadjuvant chemotherapy as compared to clinical palpation, ultrasound techniques and histo-pathological outcome. []

    5. The false-negative rate of the sentinel node biopsy after neoadjuvant chemotherapy. []

    6. The disease-free and overall survival after 3 and 5 years follow-up. []

    7. The relation between pCR and DFS/OS. []

    8. The feasibility of the criteria for reporting pathological tumour response in surgical breast and axillary node resection specimens. []

    9. The prognostic and predictive value of tumour- and molecular markers, including ER, PgR, c-erbB2, microarray and other tumour characteristic analyses. []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Onze Lieve Vrouwe Gasthuis Amsterdam Netherlands
    2 Rijnstate Ziekenhuis Arnhem Netherlands
    3 Jeroen Bosch Ziekenhuis Den Bosch Netherlands
    4 HAGA Ziekenhuis Den Haag Netherlands
    5 Deventer Ziekenhuis Deventer Netherlands
    6 Slingeland Hospital Doetinchem Netherlands
    7 Catharina Ziekenhuis Eindhoven Netherlands
    8 St. Anna Hospital Geldrop Netherlands
    9 St. Jansdal Ziekenhuis Harderwijk Netherlands
    10 Atrium Medisch Centrum Heerlen Netherlands
    11 Elkerliek Ziekenhuis Helmond Netherlands
    12 Spaarne Ziekenhuis Hoofddorp Netherlands
    13 Leids Universitair Medisch Centrum (LUMC) Leiden Netherlands
    14 Academical Hospital Maastricht (AZM) Maastricht Netherlands
    15 St. Antonius Hospital Nieuwegein Netherlands
    16 Canisius Wilhelmina Ziekenhuis Nijmegen Netherlands
    17 Radboud University Medical Centre Nijmegen Netherlands
    18 Waterland Hospital Purmerend Netherlands
    19 Maasland Hospital Sittard Netherlands
    20 St. Elisabeth Ziekenhuis Tilburg Netherlands
    21 Mesos Medisch Centrum Utrecht Netherlands
    22 UMC Utrecht Utrecht Netherlands
    23 Maxima Medisch Centrum Veldhoven Netherlands
    24 Zaans Medical Centre Zaandam Netherlands

    Sponsors and Collaborators

    • Radboud University Medical Center
    • Sanofi
    • Amgen

    Investigators

    • Principal Investigator: V.C.G. Tjan-Heijnen, AZM Maastricht

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00314977
    Other Study ID Numbers:
    • IKO 2005-01 / BOOG 2007-02
    First Posted:
    Apr 17, 2006
    Last Update Posted:
    Mar 18, 2010
    Last Verified:
    Mar 1, 2010
    Keywords provided by , ,
    Large resectable breast cancer
    Locally advanced breast cancer
    Neoadjuvant therapy
    Additional relevant MeSH terms:
    Breast Neoplasms
    Cyclophosphamide
    Docetaxel
    Doxorubicin
    Liposomal doxorubicin

    Study Results

    No Results Posted as of Mar 18, 2010