Clareo Health | Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Participants Resistant to Aromatase Inhibitor Therapy
Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Participants Resistant to Aromatase Inhibitor Therapy
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
As per national or local treatment guidelines, endocrine therapy (i.e., fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not necessary for participants, at time of entry into the study.
Part I: Postmenopausal women with locally ABC or MBC whose disease relapsed during treatment with (or within 6 months after discontinuation of) an AI in the adjuvant setting or progressed during treatment with an AI in the metastatic setting.
You may not be if
Estrogen receptor (ER)-positive disease and human epidermal receptor 2 (HER2)-negative disease
Participants must have measurable disease by response evaluation criteria in solid tumors (RECIST) version (v) 1.1 or bone-only disease with radiologic scans
Adequate hematologic and end-organ function
Prior treatment with fulvestrant, phosphoinositide 3-kinase (PI3K) inhibitor, or mechanistic target of rapamycin (mTOR) inhibitor for ABC or MBC
Prior anti-cancer therapy or radiotherapy within 2 weeks prior to Day 1 of Cycle 1
Prior treatment with greater than (\>) one cytotoxic chemotherapy regimens or experienced recurrent or progressive disease on \> two endocrine therapies for MBC
Participants requiring anti-hyperglycemic therapy
Clinically significant cardiac or pulmonary dysfunction
History of malabsorption syndrome or other condition that would interfere with enteral absorption
Clinically significant history of liver disease
Active uncontrolled autoimmune disease or active inflammatory disease
Immunocompromised status
Need for current chronic corticosteroid therapy
Pregnancy, lactation, or breastfeeding
Current severe, uncontrolled systemic disease
Symptomatic hypercalcemia
Known untreated or active central nervous system (CNS) metastases
History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or patients who have undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to be at low risk for recurrence
