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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

800

Participants

Timeline

Start Date

December 15, 2022

Primary Completion Date

December 15, 2030

Study Completion Date

December 15, 2030

Conditions
HER2-positive Breast Cancer
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 : 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)"

All Listed Sponsors
lead

Institut de cancérologie Strasbourg Europe

OTHER

NCT05388500 - Protocol for Herceptin as Adjuvant Therapy With Reduced Exposure to Chemotherapy (PHARE-C) | Biotech Hunter | Biotech Hunter