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

Description

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.

Study Start Date

December, 12 2017

Estimated Completion Date

March 2021

Interventions

  • Drug: Ipatasertib
  • Drug: Paclitaxel
  • Drug: Placebo

Study ID

Hoffmann-La Roche -- CO40016

Status

Recruiting

Trial ID

NCT03337724

Study Type

Interventional

Trial Phase

Phase 2/Phase 3

Enrollment Quota

450

Sponsor

Hoffmann-La Roche

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
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • 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:
  • Valid results from central molecular analysis confirming PIK3CA/AKT1/PTEN-altered status in tumor tissue by next-generation sequencing (NGS)

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
  • Participants with HR+/HER2
  • breast cancer for whom endocrine-based therapy is considered an appropriate option per local clinical guidelines (i.e. participants should not be considered eligible for endocrine-based treatment)
  • 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 antibiotics
  • 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
  • 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

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (69)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Memorial Sloan Kettering - New York, New York 187.1 miles None None None
Memorial Sloan Kettering - New York, New York 187.1 miles None None None
Memorial Sloan Kettering - New York, New York 187.1 miles None None None
Memorial Sloan Kettering - New York, New York 187.1 miles None None None
John Hopkins Sidney Kimmel Comprehensive Cancer Center - Baltimore, Maryland 356.0 miles None None None
John Hopkins Sidney Kimmel Comprehensive Cancer Center - Baltimore, Maryland 356.0 miles None None None
John Hopkins Sidney Kimmel Comprehensive Cancer Center - Baltimore, Maryland 356.0 miles None None None
John Hopkins Sidney Kimmel Comprehensive Cancer Center - Baltimore, Maryland 356.0 miles None None None
Mercy Medical Center - Baltimore, Maryland 358.2 miles None None None
Mercy Medical Center - Baltimore, Maryland 358.2 miles None None None
Mercy Medical Center - Baltimore, Maryland 358.2 miles None None None
Mercy Medical Center - Baltimore, Maryland 358.2 miles None None None
University of Maryland - Baltimore, Maryland 358.9 miles None None None
University of Maryland - Baltimore, Maryland 358.9 miles None None None
University of Maryland - Baltimore, Maryland 358.9 miles None None None
University of Maryland - Baltimore, Maryland 358.9 miles None None None
Mid Ohio Onc Hematology Inc - Columbus, Ohio 637.3 miles None None None
Mid Ohio Onc Hematology Inc - Columbus, Ohio 637.3 miles None None None
Mid Ohio Onc Hematology Inc - Columbus, Ohio 637.3 miles None None None
Mid Ohio Onc Hematology Inc - Columbus, Ohio 637.3 miles None None None
Northwestern Center for Clinical Research Cancer Center - Chicago, Illinois 847.9 miles None None None
Northwestern Center for Clinical Research Cancer Center - Chicago, Illinois 847.9 miles None None None
Northwestern Center for Clinical Research Cancer Center - Chicago, Illinois 847.9 miles None None None
Northwestern Center for Clinical Research Cancer Center - Chicago, Illinois 847.9 miles None None None
Rush University Medical Center Div of Hematology - Chicago, Illinois 851.3 miles None None None
Rush University Medical Center Div of Hematology - Chicago, Illinois 851.3 miles None None None
Rush University Medical Center Div of Hematology - Chicago, Illinois 851.3 miles None None None
Rush University Medical Center Div of Hematology - Chicago, Illinois 851.3 miles None None None
Vanderbilt Breast Center Vanderbilt Health Pharmacy - Nashville, Tennessee 944.0 miles None None None
Vanderbilt Breast Center Vanderbilt Health Pharmacy - Nashville, Tennessee 944.0 miles None None None
Vanderbilt Breast Center Vanderbilt Health Pharmacy - Nashville, Tennessee 944.0 miles None None None
Vanderbilt Breast Center Vanderbilt Health Pharmacy - Nashville, Tennessee 944.0 miles None None None
West Clinic - Germantown, Tennessee 1,131.3 miles None None None
West Clinic - Germantown, Tennessee 1,131.3 miles None None None
West Clinic - Germantown, Tennessee 1,131.3 miles None None None
West Clinic - Germantown, Tennessee 1,131.3 miles None None None
Memorial Regional Hospital - Hollywood, Florida 1,244.0 miles None None None
Memorial Regional Hospital - Hollywood, Florida 1,244.0 miles None None None
Memorial Hospital West - Pembroke Pines, Florida 1,247.5 miles None None None
Memorial Hospital West - Pembroke Pines, Florida 1,247.5 miles None None None
Memorial Hospital West - Pembroke Pines, Florida 1,247.5 miles None None None
Mount Sinai Comprehensive Cancer Center - Miami Beach, Florida 1,256.3 miles None None None
Mount Sinai Comprehensive Cancer Center - Miami Beach, Florida 1,256.3 miles None None None
Mount Sinai Comprehensive Cancer Center - Miami Beach, Florida 1,256.3 miles None None None
Texas Oncology PA - Dallas, Texas 1,549.2 miles None None None
Texas Oncology PA - Dallas, Texas 1,549.2 miles None None None
Texas Oncology PA - Dallas, Texas 1,549.2 miles None None None
Texas Oncology PA - Dallas, Texas 1,549.2 miles None None None
Houston Methodist Cancer Center - Houston, Texas 1,609.9 miles None None None
Houston Methodist Cancer Center - Houston, Texas 1,609.9 miles None None None
Houston Methodist Cancer Center - Houston, Texas 1,609.9 miles None None None
Houston Methodist Cancer Center - Houston, Texas 1,609.9 miles None None None
Emad Ibrahim Md Inc - Redlands, California 2,540.6 miles None None None
Emad Ibrahim Md Inc - Redlands, California 2,540.6 miles None None None
Emad Ibrahim Md Inc - Redlands, California 2,540.6 miles None None None
Emad Ibrahim Md Inc - Redlands, California 2,540.6 miles None None None
UCSD Moores Cancer Center - La Jolla, California 2,581.5 miles None None None
UC Davis Comprehensive Cancer Center - Sacramento, California 2,628.4 miles None None None
UC Davis Comprehensive Cancer Center - Sacramento, California 2,628.4 miles None None None
UC Davis Comprehensive Cancer Center - Sacramento, California 2,628.4 miles None None None
UC Davis Comprehensive Cancer Center - Sacramento, California 2,628.4 miles None None None
Kaiser Permanente Vallejo - Vallejo, California 2,678.4 miles None None None
Kaiser Permanente Vallejo - Vallejo, California 2,678.4 miles None None None
Kaiser Permanente Vallejo - Vallejo, California 2,678.4 miles None None None
Kaiser Permanente Vallejo - Vallejo, California 2,678.4 miles None None None

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