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NCT Number: NCT05388500

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

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.

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Key information

Conditions

HER2-positive Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paclitaxel + Trastuzumab

Drug

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)

Trastuzumab

Drug

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 outcomes

  1. Time to progression

    Time frame: up to 5 years

    Time from the date of randomization to the date of progression

Secondary outcomes

  1. Cardiac toxicity

    Time frame: up to 5 years

    defined by Ventricular Ejection Fraction measure according to the technique used, clinical examination or any other appropriate exams

  2. Treatment toxicity

    Time frame: up to 5 years

    Adverse Event and Serious Adverse Event due to trastuzumab or paclitaxel graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  3. Total pathological Complete Response (tpCR)

    Time frame: through surgery completion, an average of 12 weeks

    Defined by complete absence of cancerous cells in breast, axillary lymph node chain and/or axillary sentinel lymph node (ypT0/is) in excised tissues

  4. Breast pathological Complete Response (bpCR)

    Time frame: through surgery completion, an average of 12 weeks

    Defined by complete absence of cancerous cells in breast (ypT0/is, ypN0) in excised tissues

  5. Distant metastasis Free Survival

    Time frame: up to 5 years

    Time from the date of randomization to the date of 1st metastasis

  6. Overall Survival

    Time frame: up to 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Manon VOEGELIN, PhD

CONTACT

[email protected]

368767360 ext. 33

Valérie SARTORI

CONTACT

[email protected]

368767223 ext. 33

Sponsors and collaborators

Lead sponsor

Institut de cancérologie Strasbourg Europe

Other

Registry information

Official study 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

Acronym: PHARE-C

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
May 24, 2022
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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