Anastrozole + Palbociclib for Breast Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but you cannot use drugs that are strong CYP3A4 inhibitors or inducers. It's best to discuss your current medications with the study team to see if any adjustments are needed.
What data supports the effectiveness of the drug combination Anastrozole and Palbociclib for breast cancer?
Research shows that Palbociclib, when combined with an aromatase inhibitor like Anastrozole, significantly prolongs progression-free survival (the time during which the cancer does not get worse) in patients with hormone receptor-positive, HER2-negative advanced breast cancer. This combination has been shown to improve clinical outcomes in several studies, including the PALOMA trials.12345
Is the combination of Anastrozole and Palbociclib safe for humans?
Anastrozole (also known as Arimidex) has been shown to be generally well-tolerated in humans, with fewer gynecologic side effects compared to tamoxifen, another breast cancer treatment. However, specific safety data for the combination of Anastrozole and Palbociclib (Ibrance) is not provided in the available research.678910
How is the drug combination of Anastrozole and Palbociclib unique for breast cancer treatment?
The combination of Anastrozole and Palbociclib is unique because it combines an aromatase inhibitor (Anastrozole) with a CDK4/6 inhibitor (Palbociclib), which works by blocking proteins that help cancer cells grow. This combination is particularly effective for treating hormone receptor-positive, HER2-negative advanced breast cancer, offering improved progression-free survival compared to using Anastrozole alone.1451112
What is the purpose of this trial?
This trial tests the safety and feasibility of using two drugs, anastrozole and palbociclib, together. It targets postmenopausal women with a specific type of breast cancer that may not respond well to other treatments. The treatment works by lowering estrogen levels and stopping cancer cells from growing. Anastrozole is used to significantly reduce plasma estrogen levels in postmenopausal women with advanced breast cancer.
Research Team
Antoinette Tan, MD
Principal Investigator
Atrium Health (formerly Carolinas HealthCare System)
Eligibility Criteria
This trial is for postmenopausal women with HR-positive, HER2-negative metastatic breast cancer. It's open to those who haven't had treatment for metastatic disease (Cohort A) or as maintenance after first-line chemo (Cohort B). Participants need measurable disease, good performance status, and normal organ function. Pre/peri-menopausal women must be on LHRH agonist therapy.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive anastrozole daily and palbociclib on Days 1-21 of a 28-day cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Anastrozole
- Palbociclib
Anastrozole is already approved in European Union, United States, Canada, Japan for the following indications:
- Breast cancer
- Early breast cancer in postmenopausal women
- Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
- First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer
- Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
- Treatment of postmenopausal women with hormone receptor-positive advanced breast cancer
- Breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Antoinette Tan, MD
Lead Sponsor
Wake Forest University Health Sciences
Lead Sponsor
Atrium Health Levine Cancer Institute
Collaborator
Pfizer
Industry Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University