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Trial record 34 of 181 for:    DCLRE1C

Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Nonmetastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT01093235
Recruitment Status : Unknown
Verified March 2010 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : March 25, 2010
Last Update Posted : March 25, 2010
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE March 24, 2010
First Posted Date  ICMJE March 25, 2010
Last Update Posted Date March 25, 2010
Study Start Date  ICMJE April 2009
Estimated Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2010)
Complete pathological response rates (tumor and lymph nodes)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2010)
  • Disease-free survival
  • Overall survival
  • Pathological complete response rate in breast alone
  • Radiological response after 3 and 6 courses of chemotherapy
  • Rate of breast conservation
  • Toxicities, including cardiac safety and surgical complications (wound healing, bleeding, and thrombosis)
  • Quality of life
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Nonmetastatic Breast Cancer
Official Title  ICMJE ARTemis - Avastin Randomized Trial With Neo-Adjuvant Chemotherapy for Patients With Early Breast Cancer
Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, fluorouracil, epirubicin hydrochloride, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving combination chemotherapy together with or without bevacizumab is more effective in treating patients with nonmetastatic breast cancer.

PURPOSE: This randomized phase III trial is studying how well giving combination chemotherapy works compared with giving combination chemotherapy together with bevacizumab in treating patients with nonmetastatic breast cancer.

Detailed Description

OBJECTIVES:

Primary

  • To compare the efficacy of neoadjuvant therapy comprising docetaxel, fluorouracil, epirubicin hydrochloride, and cyclophosphamide with versus without bevacizumab in patients with HER2-negative nonmetastatic breast cancer.

Secondary

  • To assess quality of life of female patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to age (≤ 50 years old vs > 50 years old), estrogen receptor status (negative [Allred score 0-2] vs weakly positive [Allred score 3-5] vs strongly positive [Allred score 6-8]), total tumor size* (≤ 50 mm vs > 50 mm), clinical involvement of axillary nodes (yes vs no), and inflammatory/locally advanced disease (T4) (yes vs no). Patients are randomized to 1 of 2 treatment arms.

NOTE: *In cases with multifocal disease in one breast, or bilateral disease, the size to be used for the stratification is the sum of the single largest diameter of all measurable tumors.

  • Arm I: Patients receive docetaxel IV on day 1; treatment repeats every 3 weeks for 3 courses. Patients then receive fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1 (FEC). Treatment with fluorouracil, epirubicin hydrochloride, and cyclophosphamide repeats every 3 weeks for 3 courses.
  • Arm II: Patients receive bevacizumab IV over 30 to 90 minutes and docetaxel IV on day 1; treatment repeats every 3 weeks for 3 courses. Patients then receive FEC as in arm I. Treatment with FEC repeats every 3 weeks for 3 courses. Patients also receive bevacizumab IV over 30 to 90 minutes and docetaxel IV on day 1 in FEC course 1 only.

Within 3-6 weeks after completion of last dose of study therapy, patients in both arms undergo surgery. Within 4-8 weeks after surgery, patients undergo radiotherapy according to standard protocol.

Women complete quality-of-life questionnaires (FACT-B and EuroQoL) at baseline and during and after completion of study treatment.

After completion of study treatment, patients are followed every 6 months for 2 years and then annually for 3 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Cardiac Toxicity
  • Perioperative/Postoperative Complications
Intervention  ICMJE
  • Biological: bevacizumab
  • Drug: cyclophosphamide
  • Drug: docetaxel
  • Drug: epirubicin hydrochloride
  • Drug: fluorouracil
  • Procedure: assessment of therapy complications
  • Procedure: neoadjuvant therapy
  • Procedure: quality-of-life assessment
  • Procedure: therapeutic conventional surgery
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 24, 2010)
800
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive breast cancer
  • HER2-negative disease

    • IHC 0/1 OR IHC 2+ and FISH negative
  • Must meet 1 of the following criteria:

    • Unifocal tumor meeting 1 of the following criteria:

      • T2 or T3 tumors (radiological size > 20 mm)
      • T4 tumor of any size with direct extension to the chest wall or the skin
      • Inflammatory carcinoma with tumor of any size
    • Multifocal tumor meeting the following criteria:

      • The sum of each tumors' maximum diameter must be ≥ 20 mm (total radiological tumor size ≥ 20 mm)
    • Other locally advanced disease meeting 1 of the following criteria:

      • Any T stage with involvement of large or fixed axillary lymph nodes (radiological diameter > 20 mm or clinical N2) and primary breast tumor of any diameter
      • Any T stage with involvement of large or fixed axillary lymph nodes (radiological diameter > 20 mm or clinical N2), without a primary breast tumor identified and the presence of breast cancer in a lymph node must be histopathologically confirmed by lymph node biopsy (tru-cut or whole lymph node)
  • Embedded paraffin tumor block available from pre-chemotherapy biopsy and surgical specimen
  • Bilateral disease allowed
  • No evidence of metastatic disease
  • No prior breast cancer except for ductal carcinoma in situ of the breast surgically cured > 10 years ago
  • Any hormone receptor status

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • WBC > 3 x 10^9/L
  • Hemoglobin > 10 g/dL
  • Platelet count > 100 x 10^9/L
  • AST/ALT ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2 times ULN
  • Bilirubin normal

    • Isolated elevation of bilirubin to ≤ 3 times ULN with a presumptive diagnosis of Gilbert syndrome allowed if AST/ALT and alkaline phosphatase are within normal limits
  • Creatinine ≤ 1.5 times ULN
  • PT and PTT/aPTT ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception
  • Must be fit to receive chemotherapy on this trial, in the opinion of the responsible clinician, as indicated by the following criteria:

    • No clinically significant cardiac abnormalities
    • No myocardial infarction within the past 6 months
    • LVEF normal (at least 50%) by MUGA scan or echocardiogram
  • No prior ischemic heart disease, cerebrovascular disease, peripheral vascular disease, arterial or venous thromboembolic disease, cardiac failure, inflammatory bowel disease, gastroduodenal ulcer, symptomatic diverticulitis, or bleeding diathesis
  • No uncontrolled hypertension (systolic BP > 150 mm Hg or diastolic BP > 90 mm Hg) with or without antihypertensive medication

    • Patients with initial blood pressure elevations are eligible provided initiation or adjustment of antihypertensive medication lowers pressure to meet entry criteria
  • No other previous malignancy except basal cell carcinoma, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast treated by surgery only and disease-free for 10 years
  • No concurrent medical or psychiatric problem that might prevent completion of treatment or follow-up
  • No presence of active uncontrolled infection
  • No history of nephritic or nephrotic syndrome
  • No traumatic injury within the past 28 days
  • No evidence of other disease that, in the opinion of the investigator, places the patient at high risk of treatment-related complications
  • No nonhealing wound, peptic ulcer, or bone fracture

PRIOR CONCURRENT THERAPY:

  • No prior neoadjuvant endocrine therapy
  • No prior chemotherapy or radiotherapy
  • No major surgical procedure within the past 28 days
  • No concurrent full therapeutic dose of anticoagulants or aspirin > 325 mg/day, clopidogrel > 75 mg/day, or corticosteroids
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01093235
Other Study ID Numbers  ICMJE CDR0000668530
CRCA-CCTC-WCTU-ARTemis
ISRCTN68502941
EUDRACT-2008-002322-11
EU-21017
MREC-08/H1102/104
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Cambridge University Hospitals NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Helena Earl, MBBS, PhD, FRCP Cambridge University Hospitals NHS Foundation Trust
PRS Account National Cancer Institute (NCI)
Verification Date March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP