Clareo Health | A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer)
A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Women who are postmenopausal or premenopausal/perimenopausal
For women who are premenopausal or perimenopausal and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy for the duration of study treatment
Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
Documented ER-positive tumor and HER2-negative tumor, assessed locally
Disease progression after treatment with one or two lines of systemic therapy (but not more than one prior targeted therapy) in the locally advanced or metastatic setting
Measurable disease as defined per RECIST v.1.1 or bone only disease which must have at least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Adequate organ function
You may not be if
Prior treatment with a selective estrogen receptor degrader (SERD), with the exception of fulvestrant, if fulvestrant treatment was terminated at least 28 days prior to randomization
Treatment with any investigational therapy within 28 days prior to randomization
Advanced, symptomatic, visceral spread that is at risk of life-threatening complications
Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
Active cardiac disease or history of cardiac dysfunction
