Neoadjuvant Therapy in Clinical Stage I-III HER2-positive Breast Cancer.

PHASE2CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

November 21, 2016

Primary Completion Date

November 14, 2019

Study Completion Date

March 27, 2020

Conditions
Breast Cancer
Interventions
DRUG

paclitaxel

80 mg/m2 (or nab-paclitaxel 80-100 mg/m2) weekly

DRUG

Trastuzumab

Either every 3 weeks (8 mg/kg cycle 1 then 6 mg/kg cycles 2-4) or weekly (4 mg/kg week 1 then 2 mg/kg weeks 2-12)

DRUG

Pertuzumab

every 3 weeks (840 mg cycle 1 then 420 mg cycles 2-4) or weeks 1 and 2 cycle 1 (420 mg each dose) during the first 3-6 weeks of treatment, then 420 mg day 1 of cycles 2-4.

DRUG

carboplatin

AUC 2 administered weekly with no planned treatment breaks

PROCEDURE

Breast surgery

breast conserving or mastectomy

DRUG

AC

"doxorubicin and cyclophosphamide (AC) every 2 or 3 weeks for 4 cycles~Dose-dense AC: Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 IV day 1 every 2 weeks x 4 cycles~Standard AC: Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 IV day 1 r every 3 weeks x 4 cycles"

Trial Locations (2)

02903

Rhode Island Hospital and The Miriam Hospital, Providence

02905

Women and Infants hospital of RI, Providence

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Women and Infants Hospital of Rhode Island

OTHER

collaborator

Rhode Island Hospital

OTHER

collaborator

The Miriam Hospital

OTHER

lead

Brown University

OTHER

NCT02789657 - Neoadjuvant Therapy in Clinical Stage I-III HER2-positive Breast Cancer. | Biotech Hunter | Biotech Hunter