NCT02345772

Neoadjuvant Hormonal Therapy Combined With Chemoimmunotherapy

Neoadjuvant Hormonal Therapy Combined With Chemoimmunotherapy (Taxotere, Trastuzumab and Pertuzumab) in Patients With HER2-positive and ER-Positive Breast Cancer (NeoHTTP Study)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Western Regional Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hormonal therapy administered before surgery in ER-positive and HER2-positive patients with breast cancer.

Detailed description

Hormonal therapy with fulvestrant 500 mg to be administered before surgery With docetaxel, Trastuzumab, and pertuzumab to determine pathological complete remission rate at the time of surgery in ER-positive and HER2-positive patients with breast cancer.

Conditions

• HER2-positive Breast Cancer
• ER-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	fulvestrant 500 mg	Hormonal therapy with fulvestrant 500 mg will be administered intramuscularly on days 1, 15 of the first cycle, and thereafter on day 1 of every 28-day cycle for up to 5 cycles before surgery.
DRUG	Docetaxel	Docetaxel (T) 75 mg/m2 every 3 weeks will be given for four cycles.
DRUG	Trastuzumab (H, 8mg/kg	Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent cycles before and after surgery), pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery.
DRUG	Pertuzumab (P, 840 mg	Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent cycles before and after surgery), pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery.

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2015-01-26
• Last updated: 2018-02-20
• Results posted: 2017-10-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study