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A Study of Ipatasertib in Combination With Paclitaxel for PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative or Hormone Receptor-Positive, HER2-Negative Breast Cancer
Overall Recruitment Status: Active, currently enrolling
 
Official Title
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
 
Region Sponsors
California - Northern
Hoffmann-La Roche
 
Acronym KP IRB No.
IPATunity CN-18-315
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Women with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and women 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
 
Purpose
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
 
Detailed Description
This is 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. Time Frame for Progression-Free Survival (PFS): From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, up to approximately 53 months. Progression-Free Survival (PFS) as determined by the Investigator using Response Evaluation Criteria In Solid Tumors (RECIST).
 
Gender Age Limit
Male & Female
 
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
  • Please contact Study Team for more criteria
 
Exclusion Criteria
  • Later

 
Keywords and/or Specific Medical Conditions
  • Breast Diseases Skin Diseases Paclitaxel Albumin-Bound Paclitaxel Hormones Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs
  • Triple Negative Breast Neoplasms
  • Neoplasms
  • Breast Neoplasms
  • Neoplasms by Site
  • Oncology (Adult)
 
KP Clinical Facility
  • Vallejo Medical Center
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Jennifer Marie Suga, MD
Contact Information:


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