Status:
NOT_YET_RECRUITING
Protocol for Herceptin as Adjuvant Therapy With Reduced Exposure to Chemotherapy (PHARE-C)
Lead Sponsor:
Institut de cancérologie Strasbourg Europe
Conditions:
HER2-positive Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: According to previous results from PHARE study, a subgroup of patients with low-risk cancer (\< 3 cm) without axillary lymph node involvement or small (\< 2 cm) with minimal lymph node invo...
Detailed Description
PHARE-C is an open-label, randomized, phase III, non-inferiority trial, that will recruit patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer to allow for compar...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the breast, nonmetastatic disease and non operated tumor
- Without suspicious axillary nodes
- Tumor size \< 30 mm
- Eligibility to receive a weekly paclitaxel based chemotherapy for this cancer
- Left Ventricular Ejection Fraction (LVEF) obtained and \> 50% as measured by echocardiography (Simpson method) or multigated acquisition scan (MUGA) at 3 months (-/+ 1 month)
- Overexpression of HER-2 in the invasive component of the primary tumor as indicated by one of the following:
- 3+ by immunohistochemistry (IHC) 2+ by IHC and confirmation by fluorescent in situ hybridization (FISH) or chromogenic in situ hybridization (CISH)
- With signed Informed consent
Exclusion
- Previous anti-HER2 treatment (except for HERCEPTIN)
- Cardiac disease or other medical conditions preventing trastuzumab administration
- Known allergy to trastuzumab, murine proteins or other excipients
- Pregnant or breastfeeding women
- Patients that are not able to comply to the protocol assessments for geographic, social or psychological reasons
Key Trial Info
Start Date :
December 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2030
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT05388500
Start Date
December 15 2022
End Date
December 15 2030
Last Update
May 27 2022
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