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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00381901
First received: September 26, 2006
Last updated: May 12, 2011
Last verified: July 2009
  Purpose

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 Intervention Phase
Breast Cancer
Biological: trastuzumab
Genetic: polymorphism analysis
Procedure: adjuvant therapy
Phase 3

Study Type: Interventional
Study Design: 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]

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to recurrence [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiotoxicity as measured by LVEF [ Designated as safety issue: Yes ]
  • Distant metastasis-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 3400
Study Start Date: May 2006
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381901

  Show 82 Study Locations
Sponsors and Collaborators
National Cancer Institute, France
Investigators
Study Chair: Xavier Pivot, MD, PhD Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
  More Information

Additional Information:
No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00381901     History of Changes
Other Study ID Numbers: CDR0000509793, INCA-PHARE, INCA-RECF0146, EUDRACT-2006-000070-67
Study First Received: September 26, 2006
Last Updated: May 12, 2011
Health Authority: United States: Federal Government

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:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014