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Breast CancerPhase 2NCT05524584

Anastrazole, Fulvestrant & Abemaciclib for HR+HER2- Metastatic Breast Cancer

A Phase 2 study testing Fulvestrant, Anastrozole and Abemaciclib in people with Breast Cancer and Metastatic Breast Cancer, run by University of California, Irvine at 1 site in United States.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Fulvestrant, Anastrozole and Abemaciclib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
31 Aug 2022to 31 Dec 2031
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have a diagnosis of HR+ breast cancer. To fulfill the requirement of HR+ disease, a breast cancer must express, by immunohistochemistry (IHC), at least one of the hormone receptors (ER, progesterone receptor [PgR]) as defined in the relevant American Society of Clinical Oncology/College of American Pathologists Guidelines: For ER and PgR assays to be considered positive, ≥1% of tumor cell nuclei must be immunoreactive by immunohistochemistry (IHC)
  • Patients must have newly diagnosed metastatic regional breast cancer (Stage IV per AJCC 8th edition criteria for staging of breast cancer) or local-regional advanced or recurrent cancer not amenable to curative treatment
  • 1. Relapse > 12 months from completion of (neo)adjuvant endocrine and/or chemotherapy with no treatment for advanced or metastatic disease (patients with no early stage breast cancer neoadjuvant or adjuvant systemic treatment may qualify)
  • Age ≥ 18 years
  • ECOG performance status 0-2
  • Have post-menopausal status as defined by following: Prior bilateral oophorectomy. Age ≥ 60 years, Age < 60 and amenorrheic (non-treatment-induced amenorrhea secondary to tamoxifen, toremifene, ovarian suppression, or chemotherapy) for at least 12 months. Follicle-stimulating hormone (FSH) and estradiol must be in the postmenopausal range. If patients are pre-menopausal ovarian function suppression will be initiated.
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  • Have at least one measurable disease as defined per RECIST 1.1
  • Adequate organ and marrow function as defined below:
  • Hemoglobin >8 g/dL. Patients may receive transfusion of packed red blood cells (PRBC) to achieve this hemoglobin level at the discretion of the investigator; however, initial study drug treatment must not begin earlier than the day after the PRBC transfusion
  • Absolute neutrophil count ≥1,500/mcL
  • Platelets ≥ 100,000/mcl
  • Total bilirubin ≤ 1.5 X institutional ULN. Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted
  • AST (SGOT)/ALT (SPGT) ≤ 2.5 X institutional ULN
  • Creatinine ≤ 1.5 X institutional ULN
  • Able to swallow oral medications
  • Patients who received chemotherapy or curative radiotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute effects of chemotherapy and curative radiotherapy except for residual alopecia (of any grade) or Grade 2 peripheral neuropathy prior to enrollment.
  • Person of child bearing potential (POCBP) (ie. premenopausal) and men must agree to use ovarian or testicular suppression prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
  • A post-menopausal female patient is defined by one of the following for female patients: prior bilateral oophorectomy, age ≥ 60 years, age < 60 and amenorrheic (non-treatment-induced amenorrhea secondary to tamoxifen, toremifene, ovarian suppression, or chemotherapy) for at least 12 months.
  • If follicle-stimulating hormone (FSH) and estradiol labs were performed as standard practice within the screening window and the patient is post-menopausal, those lab results must be in the postmenopausal range. These labs are not required to be performed for the study.
  • POCBP are required to initiate effective contraception by study intervention start. Effective contraception is per the investigator's discretionhild. A POCBP (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) is someone who meets at least one of the following criteria:
  • Has not undergone a hysterectomy or bilateral oophorectomy; or
  • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
  • Must be able to sign a written informed consent, are reliable, willing to be available for the duration of the study and are willing to follow study procedures.
  • Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, deaf, hard of hearing and illiterate individuals are eligible for this trial.

Who cannot join

  • Localized breast cancer which is curable with surgery or radiation, with or without chemotherapy. This study will utilize the American Joint Committee on Cancer (AJCC) staging system, eight edition that provides a strategy for grouping patients with respect to prognosis. The AJCC has designated staging by TNM classification.
  • Current diagnosis of inflammatory breast cancer
  • Patients who have had chemotherapy or radiotherapy within 12 months prior to entering the study.
  • (Note: Palliative radiotherapy is does not require a washout Note: For current diagnosis, CDK 4/6 inhibitor and/or endocrine therapy within 8 weeks prior to starting study treatment is allowed).
  • Prior treatment with Fulvestrant (Note: For the current diagnosis, fulvestrant initiated within 8 weeks prior to starting study intervention is allowed)
  • Patients are currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged by the investigator not to be scientifically or medically compatible with this study. If a patient is currently enrolled in a clinical trial involving non-approved use of a device, then agreement with the principal investigator is required to establish eligibility
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  • Have serious pre-existing medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example, history of major surgical resection involving the stomach or small bowel or preexisting Crohn's disease or ulcerative colitis , interstitial lung disease, severe dyspnea at rest, any pre-existing chronic condition resulting in baseline grade 2 or higher diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements)
  • Have a personal history of any of the following conditions: syncope or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation or sudden cardiac arrest
  • Have a history of any other cancer (except for non-melanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission with no therapy for a minimum of three years or have received an autologous or allogeneic stem-cell transplant ((> 5 years from stem cell transplant is acceptable). (Patients with non-active cancer not requiring treatment are allowed to be enrolled on the study)
  • Have an active bacterial or fungal infection or a detectable viral infection (for example HIV or viral hepatitis). Screening is not required for enrollment
  • Recent therapy with a biologic agent or a monoclonal therapy is excluded. Wash out of at least three half-lives of monoclonal antibody would be required to be enrolled.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to CDK4/6 inhibitors or other agents used in study.
  • Patients who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chao Family Comprehensive Cancer Center University of California, Irvine contact

1-877-827-7883

ucstudy@uci.edu

University of California Irvine Medical contact

United States1 site, 1 recruiting

  • Chao Family Comprehensive Cancer Center, University of California, Irvine

    Orange, California, 92868

    Ritesh Parajuli, MD, 877-827-8839, ucstudy@uci.edu

    Recruiting

Other trials in United States

About this study

Official title: Phase II, Open-Labeled, Single-Armed Combination Treatment With Anastrozole, Fulvestrant and Abemaciclib for Hormone Receptor Positive, HER2(-) Metastatic Breast Cancer

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.

Being tested
Fulvestrant, Anastrozole, Abemaciclib
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05524584
Study groupRoleWhat they receive
Fulvestrant + Anastrozole + AbemaciclibExperimentalFulvestrant, intramuscular, Initial: 500 mg on days 1 and 15; Maintenance: 500 mg once monthly. Anastrozole, oral, 1mg tablet daily Abemaciclib 150 mg twice daily
Receives: Drug: Fulvestrant; Drug: Anastrozole; Drug: Abemaciclib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    ORR per RECIST 1.1 criteria assessed at 3 months after study treatment. The rate of objective response is calculated only for patients with measurable disease.

    Measured: Assessed at 3 months after study treatment

Secondary outcomes (5)

  1. Clinical Benefit Rate

    Calculated by using the number of patients with a complete or partial response or stable disease as the numerator and the number of all patients (even those in whom a response cannot be assessed or for whom response data are missing) as the denominator

    Measured: Up to 5 years

  2. Progression-Free Survival (PFS)

    Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.

    Measured: Up to 5 years

  3. Overall survival

    Time from first treatment to death from any cause

    Measured: Up to 5 years

  4. Number of grade 3-5 adverse events

    Safety and toxicity will be examined by the incidence of treatment-emergent, treatment-related adverse events (TRAEs), and serious adverse events (SAE). Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0.

    Measured: Up to 5 years

  5. Number of patients who achieved composite outcome

    Absolute values and changes in ctDNA and CTC will be measured and correlated with endocrine resistance. If serial monitoring of ctDNA and CTC can provide markers of resistance, we will quantify endocrine resistance as a composite outcome.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2022
  2. Study start31 Aug 2022
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05524584
Sponsor's protocol ID
1459
Other IDs
UCI 19-145
Status last verified
Nov 2025
First submitted
24 Aug 2022
Last updated
15 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

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