NCT05388500

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

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Institut de cancérologie Strasbourg Europe · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
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 : patients will receive trastuzumab emtansine (T-DM1)
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)

Timeline

• Start date: 2022-12-15
• Primary completion: 2030-12-15
• Completion: 2030-12-15
• First posted: 2022-05-24
• Last updated: 2022-05-27