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Protocol for Herceptin as Adjuvant Therapy With Reduced Exposure to Chemotherapy (PHARE-C)
Sponsor: Institut de cancérologie Strasbourg Europe
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.
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
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
800
Start Date
2022-12-15
Completion Date
2030-12-15
Last Updated
2022-05-27
Healthy Volunteers
No
Conditions
Interventions
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)
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)