Ignite Creation Date:
2024-05-06 @ 9:15 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02942355
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2016-10-19
Brief Title:
Trial of Anastrozole and Palbociclib in Metastatic HER2-Negative Breast Cancer
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Pilot Trial of Anastrozole and Palbociclib as First-Line Therapy and as Maintenance Therapy After First Line Chemotherapy in Hormone Receptor Positive HER2-Negative Postmenopausal Metastatic Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
A total of 40 subjects will be enrolled over an enrollment period of 18-24 months The study is planned to enroll up to 25 patients in Cohort A upfront and 15 patients in Cohort B maintenance Subjects will be recruited through Levine Cancer Institute locations and through referrals Women of any race or ethnic origin who meet the study criteria may participate in this clinical trial Males will not be eligible for this study Breast cancer in men is rare and the efficacy of aromatase inhibitors in males is limited Children are not included in this clinical trial because the effects of palbociclib are not known in the pediatric population but may be eligible for other pediatric trials
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| LCI-BRE-H2N-ANPA-001 | OTHER | Atrium Health | None |
| 00017766 | OTHER | None | None |