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

Institut de cancérologie Strasbourg Europe

Status and phase

Not yet enrolling

Phase 3

Conditions

HER2-positive Breast Cancer

Treatments

Drug: Paclitaxel + Trastuzumab

Drug: Trastuzumab

Study type

Interventional

Funder types

Other

Identifiers

NCT05388500

2022-008

Details and patient eligibility

About

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.

Full 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.

Enrollment

800 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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