A Study of Pertuzumab in Combination With Trastuzumab Plus an Aromatase Inhibitor in Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive and Hormone Receptor-Positive Advanced Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/2/2019
Start Date:February 17, 2012
End Date:October 26, 2019

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

A Randomized, Two-Arm, Open-Label, Multicenter Phase II Trial Assessing the Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab Plus an Aromatase Inhibitor in First Line Patients With HER2-Positive and Hormone Receptor-Positive Advanced (Metastatic or Locally Advanced) Breast Cancer

This randomized, open-label, two-arm, multi-center, Phase II study will evaluate the efficacy
and safety of pertuzumab in combination with trastuzumab plus an aromatase inhibitor (AI) in
first-line participants with HER2-positive and hormone receptor-positive advanced breast
cancer. Participants will be randomized to one of two treatment arms; Arm A (pertuzumab in
combination with trastuzumab plus an AI) or Arm B (trastuzumab plus an AI). Participants may
also receive induction chemotherapy (a taxane, either docetaxel or paclitaxel) at the
investigator's discretion in combination with the assigned treatment arm. The anticipated
time on study treatment is until disease progression, unacceptable toxicity, withdrawal of
consent, or death whichever occurs first.


Inclusion Criteria:

- Participants with HER2-positive and hormone receptor-positive advanced metastatic or
locally advanced breast cancer

- Post-menopausal status over 1 year

- HER2-positive as assessed by local laboratory on primary or metastatic tumor

- Hormone-receptor positive defined as estrogen receptor-positive and/or progesterone
receptor-positive

- At least one measurable lesion and/or non-measurable disease evaluable according to
Response Evaluation Criteria In Solid Tumors Version 1.1

Exclusion Criteria:

- Previous systemic non-hormonal anticancer therapy in the metastatic or locally
advanced breast cancer setting

- Previous treatment with anti-HER2 agents for breast cancer, except trastuzumab and/or
lapatinib in the neoadjuvant or adjuvant setting

- Disease progression while receiving adjuvant trastuzumab and/or lapatinib treatment

- History of persistent Grade 2 or higher hematological toxicity according to National
Cancer Institute-Common Toxicity Criteria Version 4.0

- Disease-free interval from completion of adjuvant/neo-adjuvant systemic non-hormonal
treatment to recurrence of within 6 months

- Other malignancies within the last 5 years, except for carcinoma in situ of the cervix
or basal cell carcinoma

- Clinical or radiographic evidence of central nervous system metastases or significant
cardiovascular disease
We found this trial at
23
sites
100 Madison Avenue
Morristown, New Jersey 07960
?
mi
from
Morristown, NJ
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
8940 N Kendall Dr # 300E
Miami, Florida 33176
?
mi
from
Miami, FL
Click here to add this to my saved trials
1835 Savoy Drive
Atlanta, Georgia 30341
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
6501 Truxtun Avenue
Bakersfield, California 93309
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
9103 Franklin Square Drive
Baltimore, Maryland 21237
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
6410 Rockledge Dr #660
Bethesda, Maryland 20817
(301) 571-0019
Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
181 South Buena Vista Street
Burbank, California 91505
?
mi
from
Burbank, CA
Click here to add this to my saved trials
695 South Dobson Road
Chandler, Arizona 85224
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
4700 East Hale Parkway
Denver, Colorado 80220
?
mi
from
Denver, CO
Click here to add this to my saved trials
Hot Springs, Arkansas 71913
?
mi
from
Hot Springs, AR
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
161 Fort Washington Avenue
Lake Success, New York 11042
?
mi
from
Lake Success, NY
Click here to add this to my saved trials
Lake Success, New York 11042
?
mi
from
Lake Success, NY
Click here to add this to my saved trials
Marietta, Georgia 30060
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Marrero, Louisiana 70072
?
mi
from
Marrero, LA
Click here to add this to my saved trials
Norwalk, Connecticut 06856
?
mi
from
Norwalk, CT
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15232
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
660 South Euclid Avenue
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
251 Avenida Doutor Arnaldo
Sao Paulo, SP 01246
?
mi
from
Sao Paulo,
Click here to add this to my saved trials
2401 South 31st Street
Temple, Texas 76508
?
mi
from
Temple, TX
Click here to add this to my saved trials
900 Centennial Boulevard
Voorhees, New Jersey 08043
?
mi
from
Voorhees, NJ
Click here to add this to my saved trials
818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
?
mi
from
Wichita, KS
Click here to add this to my saved trials