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Neoadjuvant Hormonal Therapy Combined With Chemoimmunotherapy

NCT02345772 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2018-02-20

Study results available
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Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Western Regional Medical Center

    lead OTHER

Principal Investigators

  • Jordan Waypa, FNP · Research Director

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-11-30
Completion
2015-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02345772 on ClinicalTrials.gov