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Status:

UNKNOWN

Trastuzumab in Treating Women With HER2-Positive Early Breast Cancer

Lead Sponsor:

Warwick Medical School

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE3

Brief Summary

RATIONALE: Monoclonal antibodies, such as trastuzumab, 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...

Detailed Description

OBJECTIVES: Primary * Determine disease-free survival of women with HER2-positive early breast cancer treated with neoadjuvant or adjuvant trastuzumab (Herceptin®) for 6 months versus 12 months. Se...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed invasive breast cancer
  • No evidence of metastatic disease
  • Overexpression of HER2 receptor defined as 3+ or 2+ HER2 positivity measured by fluorescent in situ hybridization (FISH) gene amplification
  • Indication for chemotherapy based on the following clinical and histopathological features:
  • Receiving or scheduled to receive neoadjuvant chemotherapy
  • Time between diagnosis biopsy and start date of chemotherapy should be less than 1 month
  • Receiving or scheduled to receive adjuvant chemotherapy
  • Completely resected disease, with negative surgical margins (apart from deep margin if full thickness resection)
  • Marginally resected disease and/or positive sentinel nodes allowed provided patients undergo completion of surgery (breast and/or axillary clearance) after chemotherapy
  • Hormone receptor status known
  • PATIENT CHARACTERISTICS:
  • Menopausal status not specified
  • ECOG performance status 0-1
  • Adequate bone marrow, hepatic, and renal function
  • LVEF normal by ECHO or MUGA
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No clinically significant cardiac abnormalities
  • No myocardial infarction within the past 6 months
  • No uncontrolled or malignant hypertension
  • No history of atrioventricular arrhythmia and/or congestive heart failure (even under medical control), or active second or third degree cardiac block
  • No history of allergy to drugs containing polysorbate 20 and the excipient polysorbate 80 (TWEEN 80®) or history of allergy to mouse proteins
  • No co-morbidity significantly adding to risks associated with cytotoxic chemotherapy (i.e., severe chronic obstructive pulmonary disease or poorly controlled diabetes)
  • No prior diagnosis of malignancy unless managed by surgical treatment only and disease-free for 10 years
  • Prior basal cell carcinoma, cervical carcinoma in situ, or ductal carcinoma in situ of the breast allowed if treated by surgery only
  • No concomitant medical or psychiatric problems that might preclude completion of treatment or follow-up
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • No prior chemotherapy or radiotherapy
  • Concurrent radiotherapy allowed

Exclusion

    Key Trial Info

    Start Date :

    October 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    4000 Patients enrolled

    Trial Details

    Trial ID

    NCT00712140

    Start Date

    October 1 2007

    Last Update

    September 2 2011

    Active Locations (11)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (11 locations)

    1

    Addenbrooke's Hospital

    Cambridge, England, United Kingdom, CB2 2QQ

    2

    Cumberland Infirmary

    Carlisle, England, United Kingdom, CA2 7HY

    3

    Derbyshire Royal Infirmary

    Derby, England, United Kingdom, DE1 2QY

    4

    Eastbourne District General Hospital

    Eastbourne, England, United Kingdom, BN21 2UD