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

Primary Purpose

HER2-positive Breast Cancer

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Paclitaxel + Trastuzumab
Trastuzumab
Sponsored by
Institut de cancérologie Strasbourg Europe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HER2-positive Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Group A (Paclitaxel + Trastuzumab)

    Group B (Trastuzumab)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Time to progression
    Time from the date of randomization to the date of progression

    Secondary Outcome Measures

    Cardiac toxicity
    defined by Ventricular Ejection Fraction measure according to the technique used, clinical examination or any other appropriate exams
    Treatment toxicity
    Adverse Event and Serious Adverse Event due to trastuzumab or paclitaxel graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
    Total pathological Complete Response (tpCR)
    Defined by complete absence of cancerous cells in breast, axillary lymph node chain and/or axillary sentinel lymph node (ypT0/is) in excised tissues
    Breast pathological Complete Response (bpCR)
    Defined by complete absence of cancerous cells in breast (ypT0/is, ypN0) in excised tissues
    Distant metastasis Free Survival
    Time from the date of randomization to the date of 1st metastasis
    Overall Survival

    Full Information

    First Posted
    May 12, 2022
    Last Updated
    May 24, 2022
    Sponsor
    Institut de cancérologie Strasbourg Europe
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05388500
    Brief Title
    Protocol for Herceptin as Adjuvant Therapy With Reduced Exposure to Chemotherapy (PHARE-C)
    Acronym
    PHARE-C
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 15, 2022 (Anticipated)
    Primary Completion Date
    December 15, 2030 (Anticipated)
    Study Completion Date
    December 15, 2030 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institut de cancérologie Strasbourg Europe

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HER2-positive Breast Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    800 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A (Paclitaxel + Trastuzumab)
    Arm Type
    Active Comparator
    Arm Title
    Group B (Trastuzumab)
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Paclitaxel + Trastuzumab
    Intervention Description
    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 : patients will receive trastuzumab emtansine (T-DM1)
    Intervention Type
    Drug
    Intervention Name(s)
    Trastuzumab
    Intervention Description
    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 Measure Information:
    Title
    Time to progression
    Description
    Time from the date of randomization to the date of progression
    Time Frame
    up to 5 years
    Secondary Outcome Measure Information:
    Title
    Cardiac toxicity
    Description
    defined by Ventricular Ejection Fraction measure according to the technique used, clinical examination or any other appropriate exams
    Time Frame
    up to 5 years
    Title
    Treatment toxicity
    Description
    Adverse Event and Serious Adverse Event due to trastuzumab or paclitaxel graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
    Time Frame
    up to 5 years
    Title
    Total pathological Complete Response (tpCR)
    Description
    Defined by complete absence of cancerous cells in breast, axillary lymph node chain and/or axillary sentinel lymph node (ypT0/is) in excised tissues
    Time Frame
    through surgery completion, an average of 12 weeks
    Title
    Breast pathological Complete Response (bpCR)
    Description
    Defined by complete absence of cancerous cells in breast (ypT0/is, ypN0) in excised tissues
    Time Frame
    through surgery completion, an average of 12 weeks
    Title
    Distant metastasis Free Survival
    Description
    Time from the date of randomization to the date of 1st metastasis
    Time Frame
    up to 5 years
    Title
    Overall Survival
    Time Frame
    up to 5 years

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Valérie SARTORI
    Phone
    368767223
    Ext
    33
    Email
    v.sartori@icans.eu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Manon VOEGELIN, PhD
    Phone
    368767360
    Ext
    33
    Email
    promotion-rc@icans.eu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xavier PIVOT, MD, PhD
    Organizational Affiliation
    Institut de cancérologie Strasbourg Europe
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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