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

Last updated: May 24, 2022
Sponsor: Institut de cancérologie Strasbourg Europe
Overall Status: Active - Not Recruiting

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05388500
2022-008
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the breast, nonmetastatic disease and nonoperated 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 byechocardiography (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 byone of the following: 3+ by immunohistochemistry (IHC) 2+ by IHC and confirmation by fluorescent in situhybridization (FISH) or chromogenic in situ hybridization (CISH)
  • With signed Informed consent

Exclusion

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

Study Design

Total Participants: 800
Study Start date:
December 15, 2022
Estimated Completion Date:
December 15, 2030

Study 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 comparison of neoadjuvant treatment with paclitaxel plus trastuzumab versus trastuzumab as monotherapy.

Non-inferiority between the two treatment arms will be evaluated in terms of time to progression as primary objective. Treatment tolerance and cardiac toxicity will be assessed as secondary objectives.

In case of non pCR, a rescue by Trastuzumab emtansine (T-DM1) is planned to control the survival outcome.