A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/31/2019
Start Date:January 6, 2018
End Date:December 22, 2021
Contact:Reference Study ID: CO40016 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. only)

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

A Double-Blind, Placebo-Controlled, Randomized Phase III Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Patients With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer

This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel
in participants with histologically confirmed, locally advanced or metastatic triple-negative
breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor
positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2−) breast
adenocarcinoma who are not suitable for endocrine therapy.


Inclusion Criteria:

- Women or men aged =>18 years with histologically documented triple-negative breast
cancer (TNBC) or HR+/HER2- adenocarcinoma of the breast that is locally advanced or
metastatic and is not amenable to resection with curative intent

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Adequate hematologic and organ function within 14 days prior to treatment initiation

- Histologically documented TNBC or HR+/HER2- adenocarcinoma of the breast that is
locally advanced or metastatic and is not amenable to resection with curative intent

- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
v1.1

- Eligible for taxane monotherapy, as per local investigator assessment (e.g., absence
of rapid clinical progression, life-threatening visceral metastases, or the need for
rapid symptom and/or disease control which may require combination chemotherapy)

- HR+/HER2- breast cancer that is not considered appropriate for endocrine-based therapy
and meets one of the following: patient has recurrent disease <=5 years of being on
adjuvant endocrine therapy or if patient with de novo metastatic disease have
progressed within 6 months of being on first line endocrine therapy.

- Consent to submit a formalin-fixed, paraffin-embedded tumor (FFPE) tissue block or
freshly cut unstained, serial tumor slides from the most recently collected tumor
tissue for central molecular analysis

- Confirmation of biomarker eligibility using an appropriately validated molecular assay
at a diagnostic laboratory, Clinically Laboratory Improvement Amendments (CLIA) or
equivalently accredited i.e., valid results from either central testing or local
testing of tumor tissue or blood demonstrating PIK3CA/AKT1/PTEN-altered status

Exclusion Criteria:

- Treatment with approved or investigational cancer therapy within 14 days prior to
treatment initiation

- Any previous chemotherapy for inoperable locally advanced or metastatic TNBC or
HR+/HER2- adenocarcinoma of the breast (patients receiving neo/adjuvant chemotherapy
eligible provided they have at least a 12 month disease-free interval)

- History of or known presence of brain or spinal cord metastases

- Malignancies other than breast cancer within 5 years prior to treatment initiation
(except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin
carcinoma, or Stage I uterine cancer)

- Prior treatment with an Akt inhibitor (prior PI3K or mTOR inhibitors are allowed)

- History of malabsorption syndrome or other condition that would interfere with enteral
absorption or results in the inability or unwillingness to swallow pills

- Active infection requiring systemic anti-microbial treatment (including antibiotics,
anti-fungals, and anti-viral agents)

- Known human immunodeficiency virus (HIV) infection

- Known clinically significant history of liver disease consistent with Child-Pugh Class
B or C, including active viral or other hepatitis, current drug or alcohol abuse, or
cirrhosis

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to initiation of treatment (or anticipated need during study)

- Pregnant or breastfeeding, or intending to become pregnant during the study

- Clinically significant cardiac dysfunction (including NYHA Class II/III/IV heart
failure, left ventricular ejection fraction [LVEF] <50%, active ventricular arrhythmia
requiring medication, history of myocardial infarction within 6 months of treatment
initiation, clinically significant electrocardiogram [ECG] abnormalities).

- Need for chronic corticosteroid therapy of >=10 mg of prednisone per day or an
equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a
chronic disease

- Unresolved, clinically significant toxicity from prior therapy, except for alopecia
and Grade 1 peripheral neuropathy

- Uncontrolled clinical symptoms including pleural effusion, pericardial effusion, or
ascites, tumor-related pain, hypercalcemia (or symptomatic hypercalcemia requiring
continued use of bisphosphonate therapy)

- History of Type I or Type II diabetes mellitus requiring insulin

- Grade >=2 uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia

- History of or active inflammatory bowel disease or active bowel inflammation

- Clinically significant lung disease (including pneumonitis, interstitial lung disease,
idiopathic pulmonary fibrosis, cystic fibrosis, active infection/ history of
opportunistic infections)

- Treatment with strong CYP3A inhibitors or strong CYP3A inducers within 2 weeks or 5
drug-elimination half-lives, whichever is longer, prior to initiation of treatment

- Grade >=2 peripheral neuropathy
We found this trial at
38
sites
Houston, Texas 77203
?
mi
from
Houston, TX
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
?
mi
from
Portland, OR
Click here to add this to my saved trials
Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
401 North Broadway
Baltimore, Maryland 21287
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
353 Avenida Callao
Buenos Aires, C1022
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
1653 West Congress Parkway
Chicago, Illinois 60612
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Columbus, Ohio 43213
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Dallas, Texas 75246
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
102-104 Endicott Street
Danvers, Massachusetts 01923
?
mi
from
Danvers, MA
Click here to add this to my saved trials
Germantown, Tennessee 38138
?
mi
from
Germantown, TN
Click here to add this to my saved trials
?
mi
from
Hawthorne, NY
Click here to add this to my saved trials
Hollywood, Florida 33021
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Knoxville, Tennessee 37909
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
La Jolla, California 92093
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Los Angeles, California 90033
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Miami Beach, Florida 33140
?
mi
from
Miami Beach, FL
Click here to add this to my saved trials
719 Thompson Lane
Nashville, Tennessee 37204
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New York, New York 10065
?
mi
from
New York, NY
Click here to add this to my saved trials
Oakland, California 94611
?
mi
from
Oakland, CA
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Pembroke Pines, Florida 33028
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
7000 Boulder Avenue
Redlands, California 92373
?
mi
from
Redlands, CA
Click here to add this to my saved trials
Roseville, California 95678
?
mi
from
Roseville, CA
Click here to add this to my saved trials
4501 X St
Sacramento, California 95817
(916) 734-5800
UC Davis Comprehensive Cancer Center When faced with cancer, you want the best hope for...
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Sacramento, California 95825
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
1-99 Garden Street
San Francisco, California 94115
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
San Francisco, California 94115
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
275 Hospital Parkway
San Jose, California 95119
?
mi
from
San Jose, CA
Click here to add this to my saved trials
San Leandro, California 94577
?
mi
from
San Leandro, CA
Click here to add this to my saved trials
710 Lawrence Expressway
Santa Clara, California 95051
?
mi
from
Santa Clara, CA
Click here to add this to my saved trials
South San Francisco, California 94080
?
mi
from
South San Francisco, CA
Click here to add this to my saved trials
Vallejo, California 94589
?
mi
from
Vallejo, CA
Click here to add this to my saved trials
1425 South Main Street
Walnut Creek, California 94596
?
mi
from
Walnut Creek, CA
Click here to add this to my saved trials