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

March 17, 2010 updated by: Radboud University Medical Center

Sequential vs Upfront Intensified Neoadjuvant Chemotherapy in Patients With Large Resectable and/or Locally Advanced Breast Cancer. The INTENS Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Onze Lieve Vrouwe Gasthuis
      • Arnhem, Netherlands
        • Rijnstate Ziekenhuis
      • Den Bosch, Netherlands
        • Jeroen Bosch Ziekenhuis
      • Den Haag, Netherlands
        • HAGA ziekenhuis
      • Deventer, Netherlands
        • Deventer Ziekenhuis
      • Doetinchem, Netherlands
        • Slingeland Hospital
      • Eindhoven, Netherlands
        • Catharina Ziekenhuis
      • Geldrop, Netherlands
        • St. Anna Hospital
      • Harderwijk, Netherlands
        • St. Jansdal Ziekenhuis
      • Heerlen, Netherlands
        • Atrium medisch centrum
      • Helmond, Netherlands
        • Elkerliek Ziekenhuis
      • Hoofddorp, Netherlands
        • Spaarne Ziekenhuis
      • Leiden, Netherlands
        • Leids Universitair Medisch Centrum (LUMC)
      • Maastricht, Netherlands
        • Academical Hospital Maastricht (AZM)
      • Nieuwegein, Netherlands
        • St. Antonius Hospital
      • Nijmegen, Netherlands
        • Canisius Wilhelmina Ziekenhuis
      • Nijmegen, Netherlands
        • Radboud university medical centre
      • Purmerend, Netherlands
        • Waterland Hospital
      • Sittard, Netherlands
        • Maasland Hospital
      • Tilburg, Netherlands
        • St. Elisabeth Ziekenhuis
      • Utrecht, Netherlands
        • UMC Utrecht
      • Utrecht, Netherlands
        • Mesos Medisch Centrum
      • Veldhoven, Netherlands
        • Máxima Medisch Centrum
      • Zaandam, Netherlands
        • Zaans Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • adriamycin
  • hydroxyldaunorubicin
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:
  • adriamycin
  • hydroxyldaunorubicin
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The pathologic complete response rate to neoadjuvant chemotherapy.

Secondary Outcome Measures

Outcome Measure
The delivered chemotherapy dose and dose-intensity of both chemotherapy regimens
The tolerability (grade 3/4 CTC toxicities) of both chemotherapy regimens.
The clinical responses of neoadjuvant chemotherapy correlated to pathological responses after neoadjuvant chemotherapy.
The value of breast MRI in evaluating response to neoadjuvant chemotherapy as compared to clinical palpation, ultrasound techniques and histo-pathological outcome.
The false-negative rate of the sentinel node biopsy after neoadjuvant chemotherapy.
The disease-free and overall survival after 3 and 5 years follow-up.
The relation between pCR and DFS/OS.
The feasibility of the criteria for reporting pathological tumour response in surgical breast and axillary node resection specimens.
The prognostic and predictive value of tumour- and molecular markers, including ER, PgR, c-erbB2, microarray and other tumour characteristic analyses.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Sanofi
Amgen

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

April 14, 2006

First Submitted That Met QC Criteria

April 14, 2006

First Posted (Estimate)

April 17, 2006

Study Record Updates

Last Update Posted (Estimate)

March 18, 2010

Last Update Submitted That Met QC Criteria

March 17, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IKO 2005-01 / BOOG 2007-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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