20 Participants Needed

Combination Therapy for Advanced Breast Cancer

Uo
CF
Overseen ByChao Family Comprehensive Cancer Center University of California, Irvine
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of California, Irvine
Stay on Your Current MedsYou can continue your current medications while participating
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
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

What is the purpose of this trial?

This is a phase 2, open-label, singled-arm clinical trial determining efficacy of combination therapy with anastrozole, fulvestrant and abemaciclib in subjects with breast cancer. These are subjects who are newly diagnosed advanced or metastatic hormone receptor positive breast cancer or subjects who have progressed following treatment free interval of more than 12 months following adjuvant or neoadjuvant treatment.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have had chemotherapy or radiotherapy within the last 12 months, you may not be eligible. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug combination therapy for advanced breast cancer?

Research shows that abemaciclib, when combined with other treatments like fulvestrant or letrozole, significantly improves progression-free survival (the time during which the cancer does not get worse) in patients with advanced hormone receptor-positive, HER2-negative breast cancer. This suggests that the combination therapy could be effective in treating advanced breast cancer.12345

Is the combination therapy for advanced breast cancer safe?

The combination therapy involving abemaciclib has been shown to have a tolerable safety profile in clinical trials, with common side effects including diarrhea, infections, and low white blood cell counts. Most side effects were manageable, and the treatment was generally considered safe for patients with advanced breast cancer.12567

How is the drug combination of Abemaciclib, Anastrozole, and Fulvestrant unique for advanced breast cancer?

This drug combination is unique because it includes Abemaciclib, a CDK4/6 inhibitor, which helps stop cancer cells from dividing and growing, and is used alongside Anastrozole and Fulvestrant to improve progression-free survival in patients with hormone receptor-positive, HER2-negative advanced breast cancer.12568

Research Team

RM

Rita S. Mehta

Principal Investigator

Chao Family Comprehensive Cancer Center

Eligibility Criteria

This trial is for post-menopausal women with HR+HER2- advanced or metastatic breast cancer, who have relapsed more than a year after prior treatments. Participants must be over 18, in good health with proper organ function, and not currently pregnant. They should agree to contraception if of child-bearing potential.

Inclusion Criteria

My cancer returned more than a year after completing initial treatment, with no treatment for advanced stages.
I am post-menopausal.
My organs and bone marrow are working well.
See 10 more

Exclusion Criteria

My breast cancer is HER2 positive or triple negative.
I have been diagnosed with inflammatory breast cancer.
I have had chemotherapy or radiotherapy within the last year.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive combination therapy with anastrozole, fulvestrant, and abemaciclib

3 months
Fulvestrant: Initial 2 visits (in-person), Maintenance: 1 visit monthly (in-person); Anastrozole and Abemaciclib: daily oral administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Treatment Details

Interventions

  • Abemaciclib
  • Anastrozole
  • Fulvestrant
Trial OverviewThe study tests a combination therapy using Anastrazole, Fulvestrant & Abemaciclib on patients newly diagnosed with advanced breast cancer or those whose cancer returned after treatment-free interval of over 12 months.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Fulvestrant + Anastrozole + AbemaciclibExperimental Treatment3 Interventions
Fulvestrant, intramuscular, Initial: 500 mg on days 1 and 15; Maintenance: 500 mg once monthly. Anastrozole, oral, 1mg tablet daily Abemaciclib 150 mg twice daily

Abemaciclib is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Verzenio for:
  • Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
  • HR+, HER2- node-positive early breast cancer
🇪🇺
Approved in European Union as Verzenio for:
  • HR+, HER2- advanced or metastatic breast cancer
  • HR+, HER2- node-positive early breast cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials
580
Recruited
4,943,000+

Findings from Research

In a phase III trial, abemaciclib combined with endocrine therapy significantly reduced the risk of breast cancer recurrence in patients with hormone receptor positive (HR+), HER2-negative, node-positive early breast cancer, regardless of prior chemotherapy or tumor characteristics.
The combination treatment was generally well-tolerated, with manageable side effects such as diarrhea, infections, and neutropenia, making it a valuable option for high-risk patients.
Abemaciclib: A Review in Early Breast Cancer with a High Risk of Recurrence.Fung, S., Blair, HA.[2023]
Interim results from the MONARCH3 study show that abemaciclib, a CDK4/6 inhibitor, is an effective first-line treatment for advanced ER-positive, HER2-negative breast cancer.
Patients receiving abemaciclib in combination with letrozole experienced significantly improved progression-free survival compared to those receiving a placebo with endocrine therapy.
First-Line Abemaciclib Effective in ER+ Breast Cancer.[2019]
In the premenopausal subgroup of the MONARCH 2 trial, patients treated with abemaciclib plus fulvestrant experienced significantly improved median progression-free survival (PFS) of 28.6 months compared to 10.26 months for those receiving placebo plus fulvestrant, indicating strong efficacy in hormone receptor-positive, HER2-negative advanced breast cancer.
The safety profile of abemaciclib plus fulvestrant was consistent with previous findings, supporting its use as an effective treatment option for premenopausal patients who are resistant to endocrine therapy.
Abemaciclib plus fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in premenopausal women: subgroup analysis from the MONARCH 2 trial.Neven, P., Rugo, HS., Tolaney, SM., et al.[2021]

References

Abemaciclib: A Review in Early Breast Cancer with a High Risk of Recurrence. [2023]
First-Line Abemaciclib Effective in ER+ Breast Cancer. [2019]
Abemaciclib plus fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in premenopausal women: subgroup analysis from the MONARCH 2 trial. [2021]
MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy. [2022]
Safety and efficacy of abemaciclib plus endocrine therapy in older patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: an age-specific subgroup analysis of MONARCH 2 and 3 trials. [2022]
MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer. [2022]
Potent Cell-Cycle Inhibition and Upregulation of Immune Response with Abemaciclib and Anastrozole in neoMONARCH, Phase II Neoadjuvant Study in HR+/HER2- Breast Cancer. [2023]
Abemaciclib: First Global Approval. [2019]