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A Study Evaluating the Efficacy and Safety of GDC-0077 + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer
Overall Recruitment Status: Enrollment on-hold
 
Official Title
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of GDC-0077 Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer
 
Region Sponsors
Colorado
Hoffmann-La Roche
 
Acronym KP IRB No.
1509484
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Individuals with confirmed diagnosis of Breast Cancer
 
Purpose
This study will evaluate the efficacy, safety, and pharmacokinetics of GDC-0077 in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in patients with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.
 
Detailed Description
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Confirmed diagnosis of HR+/HER2- breast cancer
  • Metastatic or locally advanced disease not amenable to curative therapy
  • Progression of disease during adjuvant endocrine treatment or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen
  • Receiving LHRH agonist therapy for at least 2 weeks prior to Day 1 of Cycle 1 if pre/peri-menopausal
  • Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)
  • Consent to provide fresh or archival tumor tissue specimen
  • Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1, "bone-only" disease, even if considered measurable, is not eligible
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1 Life expectancy of =/> 6 months
  • Adequate hematologic and organ function within 14 days prior to initiation of study treatment
 
Exclusion Criteria
  • Metaplastic breast cancer
  • Any history of leptomeningeal disease or carcinomatous meningitis
  • Any prior systemic therapy for metastatic breast cancer
  • Prior treatment with fulvestrant or any selective estrogen-receptor degrader
  • Prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
  • Type 2 diabetes requiring ongoing systemic treatment at the time of study entry, or any history of Type 1 diabetes
  • Known and untreated, or active CNS metastases. Patients with a history of treated CNS metastases are eligible
  • Active inflammatory or infectious conditions in either eye, or any eye conditions expected to require surgery during the study treatment period
  • Please contact study team for more eligibility criteria

 
Keywords and/or Specific Medical Conditions
  • Antineoplastic Agents
  • Molecular Mechanisms of Pharmacological Action
  • Antineoplastic Agents, Hormonal
  • Neoplasms
  • Breast Diseases
  • Neoplasms by Site
  • Breast Neoplasms
  • Palbociclib
  • Enzyme Inhibitors
  • Physiological Effects of Drugs
  • Estrogen Antagonists
  • Protein Kinase Inhibitors
  • Fulvestrant
  • Skin Diseases
  • Hormone Antagonists
  • strogen Receptor Antagonists
  • Hormones, Hormone Substitutes, and Hormone Antagonists
  • Oncology (Adult)
 
KP Clinical Facility
  • Franklin Medical Offices - Denver
  • Lone Tree Medical Offices - Lone Tree
  • Rock Creek Medical Offices - Lafayette
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Jennifer Eisenstein, MD
Contact Information:
- Kristi Bronkan, PharmD
-(303) 720-2685
-Rock Creek Medical Offices - Lafayette
-http://kpco-ihr.org/Research/Clinical_Trials.html


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