Protocol of Herceptin Adjuvant With Reduced Exposure, a Randomised Comparison of 6 Months vs 12 Months in All Women Receiving Adjuvant Herceptin [PHARE]
18 Years
N/A
Female
Breast Cancer
Trial Information
Protocol of Herceptin Adjuvant With Reduced Exposure, a Randomised Comparison of 6 Months vs 12 Months in All Women Receiving Adjuvant Herceptin [PHARE]
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Time to recurrence
Safety Issue:
No
Principal Investigator
Xavier Pivot, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Authority:
United States: Federal Government
Study ID:
CDR0000509793
NCT ID:
NCT00381901
Start Date:
May 2006
Completion Date:
Related Keywords:
- Breast Cancer
- 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
- Breast Neoplasms
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