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Trastuzumab for 6 Months or 1 Year in Treating Women With Nonmetastatic Breast Cancer That Can Be Removed By Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00381901
Recruitment Status : Completed
First Posted : September 28, 2006
Last Update Posted : May 13, 2011
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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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 carry tumor-killing substances to them. It is not yet known whether giving trastuzumab for 6 months is as effective as giving trastuzumab for 1 year in treating patients with breast cancer.

PURPOSE: This randomized phase III trial is studying trastuzumab to see how well it works when given for 6 months compared to 12 months in treating women with nonmetastatic breast cancer that can be removed by surgery.


Condition or disease Intervention/treatment Phase
Breast Cancer Biological: trastuzumab Genetic: polymorphism analysis Procedure: adjuvant therapy Phase 3

Detailed Description:

OBJECTIVES:

Primary

  • Compare the disease-free survival of women with nonmetastatic, resectable breast cancer treated with adjuvant trastuzumab (Herceptin®) for 6 months vs 12 months.

Secondary

  • Compare cardiotoxicity in patients receiving these regimens.
  • Compare the cardiotoxicity and disease-free survival of patients receiving concurrent trastuzumab and chemotherapy vs sequential administration.
  • Correlate HER-2 polymorphism with disease-free survival/cardiotoxicity in these patients.

OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to participating center, modality of adjuvant chemotherapy (concurrent vs sequential), and adjuvant hormonal therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I (control arm, 12-month therapy): Patients continue to receive trastuzumab (Herceptin®) IV until a total of 12 months of therapy is completed in the absence of disease progression or unacceptable toxicity.
  • Arm II (experimental arm, 6-month therapy): Patients continue to receive trastuzumab* IV until a total of 6 months of therapy is completed in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients who have already finished 6 months of trastuzumab at randomization do not receive further trastuzumab.

Some patients undergo blood collection for HER-2 polymorphism analysis.

After completion of study therapy, patients are followed periodically for approximately 5 years.

PROJECTED ACCRUAL: A total of 7,000 patients will be accrued for this study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3400 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Protocol of Herceptin Adjuvant With Reduced Exposure, a Randomised Comparison of 6 Months vs 12 Months in All Women Receiving Adjuvant Herceptin [PHARE]
Study Start Date : May 2006
Actual Primary Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Time to recurrence

Secondary Outcome Measures :
  1. Cardiotoxicity as measured by LVEF
  2. Distant metastasis-free survival
  3. Overall survival

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the breast

  • Nonmetastatic disease

    • Positive or negative axillary nodes
    • Tumor size ≥ 10 mm
  • Resectable disease
  • Must have received ≥ 4 courses of chemotherapy for this disease

  • A 12-month adjuvant treatment with trastuzumab (Herceptin®) has been initiated

    • Informed consent form must be signed between the third and sixth months of trastuzumab therapy

  • Overexpression of HER-2 in the invasive component of the primary tumor as indicated by 1 of the following:

    • 3+ by immunohistochemistry (IHC)
    • 2+ by IHC and confirmation by fluorescent in situ hybridization (FISH) or chromogenic in situ hybridization (CISH)
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Female
  • Menopausal status not specified
  • LVEF considered favorable for continuing trastuzumab treatment as measured by echocardiography or MUGA at 2-4 months after beginning adjuvant trastuzumab

  • No serious cardiac illness or medical condition precluding trastuzumab treatment, including any of the following:

    • History of documented congestive heart failure
    • High-risk uncontrolled arrhythmias
    • Angina pectoris requiring antianginal medication
    • Severe dyspnea at rest or oxygen-dependent
  • No known hypersensitivity to trastuzumab, murine proteins, or any of the excipients
  • Not pregnant or nursing
  • No social, geographical, or psychological condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Other prior anti-HER-2 therapy allowed
  • No prior trastuzumab other than initiation of trastuzumab adjuvant therapy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00381901


Locations
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Sponsors and Collaborators
National Cancer Institute, France
Investigators
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Study Chair: Xavier Pivot, MD, PhD Hopital Jean Minjoz
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00381901    
Other Study ID Numbers: CDR0000509793
INCA-PHARE
INCA-RECF0146
EUDRACT-2006-000070-67
First Posted: September 28, 2006    Key Record Dates
Last Update Posted: May 13, 2011
Last Verified: July 2009
Keywords provided by National Cancer Institute (NCI):
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IA breast cancer
 stage IB breast cancer
recurrent breast cancer
stage IIIC breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents