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Biomarker Study of Immune-mediated Mechanism of Action of Neoadjuvant Trastuzumab in HER2+ Breast Cancer Patients

NCT03144947 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2020-10-14

No results posted yet for this study

Summary

Phase II, Open Label, Randomized, Biomarker Study of Immune-mediated Mechanism of Action of Neoadjuvant Subcutaneous (SC) Trastuzumab in Patients with Operable or Locally Advanced /Inflammatory HER2-positive Breast Cancer (ImmunHER)

Conditions

  • Cancer, Breast

Interventions

BIOLOGICAL

Trastuzumab IV

Pre-randomization phase: FEC (fluorouracil 500 mg/m2; epirubicin 75 mg/m2; cyclophosphamide 500 mg/m2) x 3 cycles Post-randomization phase: Group A: Trastuzumab IV (8 mg/kg loading dose, followed by 6 mg/kg) plus pertuzumab IV (840 mg loading dose, followed by 420 mg) plus docetaxel (75 mg/m2)\*, every 3 weeks for 4 cycles. by 420 mg) plus docetaxel (75 mg/m2)\*, every 3 weeks for 4 cycles. \*The dose of docetaxel may be escalated to 100 mg/m 2 at the investigator's discretion on subsequent cycles if the initial dose is well tolerated. After surgery, study patients will receive trastuzumab x 14 cycles using the same formulation (SC or IV) of the preoperative phase.

BIOLOGICAL

Trastuzumab SC

Pre-randomization phase: FEC (fluorouracil 500 mg/m2; epirubicin 75 mg/m2; Group B: Trastuzumab SC (fixed dose of 600 mg) plus pertuzumab IV (840 mg loading dose, followed by 420 mg) plus docetaxel (75 mg/m2)\*, every 3 weeks for 4 cycles. \*The dose of docetaxel may be escalated to 100 mg/m 2 at the investigator's discretion on subsequent cycles if the initial dose is well tolerated. After surgery, study patients will receive trastuzumab x 14 cycles using the same formulation (SC or IV) of the preoperative phase.

BIOLOGICAL

Pertuzumab

pertuzumab IV (840 mg loading dose, followed by 420 mg) weeks for 4 cycles (both arms)

DRUG

Docetaxel

docetaxel (75 mg/m2), every 3 weeks for 4 cycles (both arms). The dose of docetaxel may be escalated to 100 mg/m2 at the investigator's discretion on subsequent cycles if the initial dose is well tolerated.

Sponsors & Collaborators

  • University Hospital of Parma: Department of Biomedical, Biotechnological and Translational Sciences, Pathological Anatomy and Histology Unit

    collaborator UNKNOWN

  • University Hospital of Parma:Laboratory of Viral Immunopathology, Unit of Infectious Diseases and Hepatology

    collaborator UNKNOWN

  • University Hospital of Parma:Statistica medica ed epidemiologia clinica-UO Ricerca e Innovazione

    collaborator UNKNOWN

  • Clirest s.r.l.

    collaborator OTHER

  • Mipharm SpA

    collaborator UNKNOWN

  • Arithmos srl

    collaborator UNKNOWN

  • Temas srl

    collaborator UNKNOWN

  • Gruppo Oncologico Italiano di Ricerca Clinica

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-29
Primary Completion
2021-03-15
Completion
2021-11-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

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 NCT03144947 on ClinicalTrials.gov