Overview

Protocol for Herceptin as Adjuvant Therapy With Reduced Exposure to Chemotherapy (PHARE-C)

Status:
Not yet recruiting
Trial end date:
2030-12-15
Target enrollment:
0
Participant gender:
Female
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 involvement (1 positive node) presented low risk of recurrence. Maintaining chemotherapy in this subgroup could cause toxicity and it is not yet known whether giving trastuzumab as monotherapy in neoadjuvant setting is as effective as giving trastuzumab combined with paclitaxel in patients with low risk early breast cancer. PURPOSE: This randomized phase III trial is studying trastuzumab as monotherapy in neoadjuvant setting to see if this treatment regimen is as efficient compared to trastuzumab combination with paclitaxel chemotherapy in treating women with low risk (tumor size< 3 cm, N0) early breast cancer.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Institut de cancérologie Strasbourg Europe
Treatments:
Paclitaxel
Trastuzumab
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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