A Study Evaluating Pertuzumab (Perjeta) Combined With Trastuzumab (Herceptin) and Standard Anthracycline-based Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced, Inflammatory, or Early-stage Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/1/2019
Start Date:July 14, 2014
End Date:August 18, 2020

Use our guide to learn which trials are right for you!

A Multicenter, Multinational, Phase II Study to Evaluate Perjeta in Combination With Herceptin and Standard Neoadjuvant Anthracycline-Based Chemotherapy in Patients With HER2-Positive, Locally Advanced, Inflammatory, or Early-Stage Breast Cancer

This multicenter, non-randomized, open-label, phase 2 study is designed to evaluate the
safety and efficacy of pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and
anthracycline-based chemotherapy as neoadjuvant treatment in participants with HER2-positive
locally advanced, inflammatory, or early-stage breast cancer. Each investigator will choose a
treatment regimen (A or B) for all of their participants to follow. Treatment regimen A (for
Cohort A) will include dose-dense doxorubicin and cyclophosphamide (ddAC), followed by
paclitaxel, with pertuzumab and trastuzumab given from the start of paclitaxel. Treatment
regimen B (for Cohort B) will include 5-fluorouracil, epirubicin, and cyclophosphamide (FEC),
followed by docetaxel, with pertuzumab and trastuzumab given from the start of docetaxel.
Participants in both cohorts will subsequently undergo surgical treatment and then resume
pertuzumab and trastuzumab treatment.


Inclusion Criteria:

- Male and female participants with locally advanced, inflammatory, or early-stage,
unilateral, and histologically confirmed invasive breast cancer. Participants with
inflammatory breast cancer must be able to have a core needle biopsy

- Primary tumor greater than (>) 2 centimeters (cm) in diameter, or > 5 millimeters (mm)
in diameter and node-positive

- HER2-positive breast cancer confirmed by a central laboratory

- Availability of tumor tissue specimen

- Baseline LVEF greater than or equal to (>/=) 55%

- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
(
- At least 4 weeks since major unrelated surgery, with full recovery

- Women of childbearing potential and male participants with partners of childbearing
potential must agree to use a "highly effective" non-hormonal form of contraception or
two "effective" forms of non-hormonal contraception by the patient and/or partner.
Contraception must continue for the duration of study treatment and for at least 7
months after the last dose of study treatment

Exclusion Criteria:

- Metastatic disease (Stage IV) or bilateral breast cancer

- Participants who have had an incisional biopsy of the primary tumor or the primary
tumor excised

- Prior breast or non-breast malignancy within 5 years prior to study entry, except for
carcinoma in situ and basal cell and squamous cell carcinoma of the skin. Participants
with malignancies occurring more than 5 years prior to study entry are permitted if
curatively treated

- Any previous systemic therapy (including chemotherapy, immunotherapy, HER2 targeted
agents, and antitumor vaccines) for cancer, or radiation therapy for cancer

- Participants with a past history of ductal carcinoma in situ (DCIS) or lobular
carcinoma in situ (LCIS) are not allowed to enter the study if they have received any
systemic therapy for its treatment or radiation therapy to the ipsilateral breast
(they are allowed to enter the study if treated with surgery alone)

- High-risk participants who have received chemopreventive drugs in the past are not
allowed to enter the study

- Inadequate bone marrow, renal, or liver function

- History or evidence of cardiovascular condition

- Dyspnea at rest or other diseases that require continuous oxygen therapy

- Severe, uncontrolled systemic disease

- Participants with poorly controlled diabetes or with evidence of clinically
significant diabetic vascular complications

- Pregnancy or breast-feeding women

- Participants who received any investigational treatment within 4 weeks of study start

- Participants with known infection with human immunodeficiency virus (HIV), hepatitis B
virus, or hepatitis C virus

- Current chronic daily treatment with corticosteroids (dose >10 mg methylprednisolone
or equivalent [excluding inhaled steroids])

- Known hypersensitivity to any of the study drugs or excipients
We found this trial at
37
sites
?
mi
from
Louisville, KY
Click here to add this to my saved trials
2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
?
mi
from
Weston, FL
Click here to add this to my saved trials
Amarillo, Texas 79106
?
mi
from
Amarillo, TX
Click here to add this to my saved trials
Bellingham, Washington 98225
?
mi
from
Bellingham, WA
Click here to add this to my saved trials
?
mi
from
Boca Raton, FL
Click here to add this to my saved trials
650 Commack Road
Commack, New York 11725
?
mi
from
Commack, NY
Click here to add this to my saved trials
235 North Belle Mead Avenue
East Setauket, New York 11733
?
mi
from
East Setauket, NY
Click here to add this to my saved trials
Farmington, New Mexico 87401
?
mi
from
Farmington, NM
Click here to add this to my saved trials
Greenbrae, California 94904
?
mi
from
Greenbrae, CA
Click here to add this to my saved trials
30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
500 Westchester Avenue
Harrison, New York 10604
?
mi
from
Harrison, NY
Click here to add this to my saved trials
Hartford, Connecticut 06105
?
mi
from
Hartford, CT
Click here to add this to my saved trials
500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
?
mi
from
Hershey, PA
Click here to add this to my saved trials
7015 A C Skinner Parkway
Jacksonville, Florida 32256
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Kalispell, Montana 59901
?
mi
from
Kalispell, MT
Click here to add this to my saved trials
4321 Washington Street
Kansas City, Missouri 64111
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
11818 Wilshire Boulevard
Los Angeles, California 90025
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
?
mi
from
Madison, WI
Click here to add this to my saved trials
340 Kennestone Hospital Boulevard
Marietta, Georgia 30060
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Minneapolis, Minnesota 55407
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
1660 Springhill Avenue
Mobile, Alabama 36604
(251) 665-8000
University of South Alabama Mitchell Cancer Institute USA Mitchell Cancer Institute (MCI) is located in...
?
mi
from
Mobile, AL
Click here to add this to my saved trials
81 Albert Street
Moncton, New Brunswick E1C 1B3
?
mi
from
Moncton,
Click here to add this to my saved trials
100 Madison Avenue
Morristown, New Jersey 07962
?
mi
from
Morristown, NJ
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
?
mi
from
New York, NY
Click here to add this to my saved trials
4200 West Memorial Road
Oklahoma City, Oklahoma 73120
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
2900 W Queen Ln
Philadelphia, Pennsylvania 19129
(215) 991-8100
Drexel University College of Medicine Drexel University College of Medicine represents the consolidation of two...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Pittsfield, Massachusetts 01201
?
mi
from
Pittsfield, MA
Click here to add this to my saved trials
Roanoke, Virginia 24014
?
mi
from
Roanoke, VA
Click here to add this to my saved trials
1000 North Village Avenue
Rockville Centre, New York 11570
?
mi
from
Rockville Centre, NY
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
45 Castro Street
San Francisco, California 94114
(415) 600-6000
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Tacoma, Washington 98405
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
?
mi
from
Washington,
Click here to add this to my saved trials
?
mi
from
Washington,
Click here to add this to my saved trials
Worcester, Massachusetts 01605
?
mi
from
Worcester, MA
Click here to add this to my saved trials
Yuma, Arizona 85364
?
mi
from
Yuma, AZ
Click here to add this to my saved trials