40 Participants Needed

Anastrozole + Palbociclib for Breast Cancer

WL
Overseen ByWendy L Vandermolen, RN
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: Antoinette Tan, MD
Must be taking: LHRH agonists
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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

AT

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

I can take care of myself and am up and about more than half of my waking hours.
My cancer can be measured by scans or is only in my bones.
I have not received treatment for metastatic disease in Cohort A.
See 8 more

Exclusion Criteria

I do not have active brain metastases or related conditions.
You are allergic to anastrozole.
I am not taking any strong medications that affect liver enzymes.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive anastrozole daily and palbociclib on Days 1-21 of a 28-day cycle

Approximately 4 years or until disease progression, unacceptable toxicity, participant withdrawal, or investigator decision

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Anastrozole
  • Palbociclib
Trial Overview The study tests combining anastrozole with palbociclib in two groups: one receiving it as a first-line therapy and the other as maintenance post-chemo. It's an open-label pilot study where patients are assigned to either Cohort A or B based on their treatment history.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Cohort B: Maintenance therapyExperimental Treatment2 Interventions
Anastrozole by mouth daily and palbociclib by mouth Days 1-21 on a 28 day cycle
Group II: Cohort A: First-line therapyExperimental Treatment2 Interventions
Anastrozole by mouth daily and palbociclib by mouth Days 1-21 on a 28 day cycle

Anastrozole is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Arimidex for:
  • Breast cancer
  • Early breast cancer in postmenopausal women
🇺🇸
Approved in United States as Arimidex for:
  • 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
🇨🇦
Approved in Canada as Arimidex for:
  • Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
  • Treatment of postmenopausal women with hormone receptor-positive advanced breast cancer
🇯🇵
Approved in Japan as Arimidex for:
  • Breast cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Antoinette Tan, MD

Lead Sponsor

Trials
3
Recruited
80+

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Atrium Health Levine Cancer Institute

Collaborator

Trials
30
Recruited
4,700+

Pfizer

Industry Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Findings from Research

Oral palbociclib is an effective treatment for HR-positive, HER2-negative advanced or metastatic breast cancer, significantly prolonging progression-free survival when used with letrozole or fulvestrant in clinical trials involving postmenopausal women.
The most common side effect was neutropenia, which was manageable and rarely led to serious complications, indicating that palbociclib can be safely administered without significantly compromising its efficacy.
Palbociclib: A Review in HR-Positive, HER2-Negative, Advanced or Metastatic Breast Cancer.Kim, ES., Scott, LJ.[2022]
Anastrozole is a potent and selective third-line aromatase inhibitor that offers a significant advancement in the treatment of hormone-sensitive breast cancer, particularly for postmenopausal women.
This review highlights anastrozole's biochemical properties and clinical efficacy, indicating its widespread use as a first- and second-line treatment option, potentially providing better outcomes and safety compared to traditional therapies like tamoxifen.
Anastrozole: pharmacological and clinical profile in postmenopausal women with breast cancer.Köberle, D., Thürlimann, B.[2018]
Palbociclib, an inhibitor of CDK4 and CDK6, was granted accelerated FDA approval for treating advanced breast cancer in postmenopausal women when combined with letrozole, based on a trial involving 165 patients that showed significant improvement in progression-free survival (PFS).
The trial demonstrated a nearly 50% reduction in the risk of disease progression for patients receiving the combination therapy compared to those on letrozole alone, although the most common side effect noted was neutropenia.
FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer.Beaver, JA., Amiri-Kordestani, L., Charlab, R., et al.[2022]

References

Palbociclib: A Review in HR-Positive, HER2-Negative, Advanced or Metastatic Breast Cancer. [2022]
Phase II, randomized trial to compare anastrozole combined with gefitinib or placebo in postmenopausal women with hormone receptor-positive metastatic breast cancer. [2018]
Real-World Treatment Patterns and Outcomes of Palbociclib Plus an Aromatase Inhibitor for Metastatic Breast Cancer: Flatiron Database Analysis. [2022]
Anastrozole: pharmacological and clinical profile in postmenopausal women with breast cancer. [2018]
FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer. [2022]
Anastrozole is superior to tamoxifen as first-line therapy for advanced breast cancer in postmenopausal women: results of a North American multicenter randomized trial. Arimidex Study Group. [2022]
Role of anastrozole in adjuvant therapy for postmenopausal patients. [2019]
Anastrozole versus tamoxifen treatment in postmenopausal women with endocrine-responsive breast cancer and tamoxifen-induced endometrial pathology. [2018]
Comprehensive side-effect profile of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: long-term safety analysis of the ATAC trial. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
A lower incidence of gynecologic adverse events and interventions with anastrozole than with tamoxifen in the ATAC trial. [2018]
The safety and efficacy of palbociclib in the treatment of metastatic breast cancer. [2017]
Anastrozole: in early breast cancer. [2018]
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