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Not yet recruiting NCT05388500

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

Phase III Interventional HER2-positive Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Paclitaxel + Trastuzumab, Trastuzumab.
Who it may be relevant to
Registry conditions: HER2-positive Breast Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Protocol for Herceptin as Adjuvant Therapy With Reduced Exposure to Chemotherapy, a Randomised Comparison of Trastuzumab vs Trastuzumab+Paclitaxel in Women With HER2-positive Early Breast Cancer Receiving Neoadjuvant Treatment

Overview

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.

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 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.

Interventions

  • Drug Paclitaxel + Trastuzumab
    Regarding neoadjuvant treatment : \- 9 to 12 weeks of neoadjuvant treatment Trastuzumab IV (8mg/kg loading dose followed by 6 mg/kg maintenance dose) or SubCutaneous (SC) (600mg fixed dose) every 3 weeks + weekly Paclitaxel IV : 80 to 90 mg/m2 Regarding adjuvant treatment patients will receive one of the following anti-HER2 therapy following the current standard to complete 1 year of anti-HER2 therapy in total : * in case of pCR : patient will receive trastuzumab * in case of non pCR : patien
  • Drug Trastuzumab
    Regarding neoadjuvant treatment : \- 9 to 12 weeks of neoadjuvant treatment Trastuzumab IV (8mg/kg loading dose followed by 6 mg/kg maintenance dose) or SC (600mg fixed dose) every 3 weeks Regarding adjuvant treatment patients will receive one of the following anti-HER2 therapy following the current standard to complete 1 year of anti-HER2 therapy in total : * in case of pCR : patient will receive trastuzumab * in case of non pCR : patients will receive trastuzumab emtansine (T-DM1)

Primary outcome measures

  • Time to progression [Time frame: up to 5 years]
Secondary outcome measures (6)
  • Cardiac toxicity [Time frame: up to 5 years]
  • Treatment toxicity [Time frame: up to 5 years]
  • Total pathological Complete Response (tpCR) [Time frame: through surgery completion, an average of 12 weeks]
  • Breast pathological Complete Response (bpCR) [Time frame: through surgery completion, an average of 12 weeks]
  • Distant metastasis Free Survival [Time frame: up to 5 years]
  • Overall Survival [Time frame: up to 5 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05388500 · 2022-008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗