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Trial of Anastrozole and Palbociclib in Metastatic HER2-Negative Breast Cancer | Clinical Trials | Clareo Health

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Trial of Anastrozole and Palbociclib in Metastatic HER2-Negative Breast Cancer

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

NCT02942355•Wake Forest University Health Sciences

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Are 18 years of age or older, who are either:
•Postmenopausal, as defined by at least one of the following criteria:
•* Age greater than or equal to 60 years;
•* Age less than 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and serum estradiol, FSH and LH level within the laboratory reference range for postmenopausal females;
•* Documented bilateral oophorectomy;
•* Medically confirmed ovarian failure OR premenopausal or perimenopausal, i.e., not meeting the criteria for being postmenopausal.
•Premenopausal or perimenopausal women can be enrolled if amenable to be treated with an LHRH agonist. Patients must have commenced treatment with an LHRH agonist at least 4 weeks prior to start of study treatment.
•Histologically or cytological confirmed diagnosis of breast cancer with evidence of metastatic disease. Locally advanced disease not amenable to resection is eligible.
•Documentation of ER-positive and, or PR-positive tumor based on most recent tumor biopsy (unless bone-only disease). ER and PR assays are considered positive if there is at least 1 percent positive in the tumor sample.
•Documentation of HER2-negative tumor based on most recent tumor biopsy. Tumor must not demonstrate overexpression of HER2 by either IHC (immunohistochemistry) or in-situ hybridization (ISH).
+12 more criteria

Exclusion Criteria

•Patient has archival tumor tissue available that is formalin-fixed and paraffin-embedded. Biopsy sample taken at the time of presentation with recurrent or metastatic disease is recommended.For patients who do not have archival tissue, tissue from a fresh biopsy should be obtained prior to study treatment initiation, if it can be safely attained using local anesthesia only. One exception is those patients with bone-only disease for whom provision of previous archival tissue would be acceptable. Serial fresh tumor tissue samples will be collected in patients with lesions amenable for a biopsy who consent to such a procedure.
•ECOG performance status 0, 1 or 2.
•Must have normal organ and marrow function as defined below:
•* Hematologic: Absolute neutrophil count greater than or equal to 1,500/mcL;
•* Platelets greater than or equal to 100,000/mcL; Hemoglobin greater than or equal to 9 g/dL.
•* Renal: Serum creatinine less than or equal to 1.5X ULN or Measured or calculated creatinine clearance (CrCl) greater than or equal to 60 mL/min for subject with creatinine levels \> 1.5X ULN \[CrCl should be calculated per institutional standard; GFR can also be used in place of creatinine or CrCl\]
•* Hepatic: Total bilirubin less than or equal to 1.5X ULN; AST(SGOT)/ALT(SGPT) less than or equal to 3X ULN (less than or equal to 5X ULN if liver metastases present); Alkaline phosphatase less than or equal to 2.5X ULN (less than or equal to 5X ULN if liver or bone metastases present)
•Able to swallow and retain oral medication per the Investigator.
•Ability to understand and the willingness to sign a written informed consent document.
•Prior treatment with any CDK inhibitor

Locations (1)

Levine Cancer Institute

Charlotte, North Carolina, United States

Key Dates

Start Date

December 7, 2016

Primary Completion Date

June 30, 2026

Completion Date

June 30, 2026

Last Updated

January 7, 2026

Enrollment

ESTIMATED participants

Conditions

Female Breast CarcinomaBreast Cancer

Interventions

anastrozole

DRUG

Palbociclib

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Trial of Anastrozole and Palbociclib in Metastatic HER2-Negative Breast Cancer

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

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Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer