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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
Study for Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer
| Sponsor: | F. HoffmannLa Roche Ltd |
| Enrolling: | Male and Female Patients |
| IRB Number: | AAAS7062 |
| U.S. Govt. ID: | NCT04191499 |
| Contact: | Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu |
Additional Study Information:
This a Phase III study designed to compare the efficacy and the safety of the triplet combination of GDC-0077 plus palbociclib and fulvestrant versus placebo plus palbociclib and fulvestrant in patients with PIK3CA-mutant, 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 locally advanced or metastatic disease.
This study is closed
Do You Qualify?
| Are you 18 years of age or older? | Yes | No |
| Do you have confirmed breast cancer that is locally advanced or metastatic? | Yes | No |
| Do you have HER2-negative breast cancer? | Yes | No |
| Do you have documented estrogen receptor (ER)-positive and/or progesterone receptor positive breast cancer cancer? | Yes | No |