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)

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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
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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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...
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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401 North Broadway
Baltimore, Maryland 21287
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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...
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353 Avenida Callao
Buenos Aires, C1022
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303 East Superior Street
Chicago, Illinois 60611
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1653 West Congress Parkway
Chicago, Illinois 60612
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Columbus, Ohio 43213
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Dallas, Texas 75246
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102-104 Endicott Street
Danvers, Massachusetts 01923
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Germantown, Tennessee 38138
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Hollywood, Florida 33021
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Houston, Texas 77030
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Houston, Texas 77203
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Knoxville, Tennessee 37909
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La Jolla, California 92093
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Los Angeles, California 90033
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Miami Beach, Florida 33140
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719 Thompson Lane
Nashville, Tennessee 37204
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New York, New York 10065
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Oakland, California 94611
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Pembroke Pines, Florida 33028
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7000 Boulder Avenue
Redlands, California 92373
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Roseville, California 95678
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4501 X St
Sacramento, California 95817
(916) 734-5800
UC Davis Comprehensive Cancer Center When faced with cancer, you want the best hope for...
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Sacramento, California 95825
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1-99 Garden Street
San Francisco, California 94115
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San Francisco, California 94115
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275 Hospital Parkway
San Jose, California 95119
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San Leandro, California 94577
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710 Lawrence Expressway
Santa Clara, California 95051
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South San Francisco, California 94080
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Vallejo, California 94589
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1425 South Main Street
Walnut Creek, California 94596
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