drugset / Trial / NCT02942355
Trial of Anastrozole and Palbociclib in Metastatic HER2-Negative Breast Cancer
Phase 2
Active not recruiting
40 enrolled
Wake Forest University Health Sciences
Atrium Health Levine Cancer Institute · collabPfizer · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is an open-label, pilot study designed to evaluate the safety and feasibility of combining anastrozole and palbociclib in the following two cohorts: Cohort A) as first-line therapy and Cohort B) as maintenance therapy after first-line chemotherapy in postmenopausal patients with HR-positive, HER2-negative metastatic breast cancer. Pre- and perimenopausal women must receive therapy with an LHRH agonist. The LHRH agonist will be by choice for an approved LHRH agonist administered according to its respective prescribing information. Following informed consent and eligibility check, subjects will be enrolled to either Cohort A or Cohort B.
Timeline
- Start
- 2016-12-07
- Primary completion
- 2028-06-30
- Completion
- 2028-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anastrozole | Other / unclassified | — | Oral |
| Subject | Palbociclib | Small molecule | — | Oral |