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

NCT05388500 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 2022-008
• Study Type: interventional
• Target: 800
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Time to progression

  Time from the date of randomization to the date of progression

  up to 5 years

Secondary Outcomes (6)

• Cardiac toxicity

  up to 5 years

• Treatment toxicity

  up to 5 years

• Total pathological Complete Response (tpCR)

  through surgery completion, an average of 12 weeks

• Breast pathological Complete Response (bpCR)

  through surgery completion, an average of 12 weeks

• Distant metastasis Free Survival

  up to 5 years

Study Arms (2)

Group A (Paclitaxel + Trastuzumab)

ACTIVE COMPARATOR

Drug: Paclitaxel + Trastuzumab

Group B (Trastuzumab)

EXPERIMENTAL

Drug: Trastuzumab

Interventions

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)

Group A (Paclitaxel + Trastuzumab)

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)

Group B (Trastuzumab)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• + by immunohistochemistry (IHC) 2+ by IHC and confirmation by fluorescent in situ hybridization (FISH) or chromogenic in situ hybridization (CISH)
• With signed Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de cancérologie Strasbourg Europe: lead

MeSH Terms

Interventions

Paclitaxel; Trastuzumab

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Xavier PIVOT, MD, PhD

  Institut de cancérologie Strasbourg Europe

  STUDY CHAIR

Central Study Contacts

Valérie SARTORI

CONTACT

368767223; v.sartori@icans.eu

Manon VOEGELIN, PhD

CONTACT

368767360; promotion-rc@icans.eu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 24, 2022
• Study Start: December 15, 2022
• Primary Completion (Estimated): December 15, 2030
• Study Completion (Estimated): December 15, 2030
• Last Updated: May 27, 2022

Record last verified: 2022-05