Anastrozole, Fulvestrant & Abemaciclib for HR+HER2- Metastatic Breast Cancer
This study is testing a combination of three drugs – anastrozole, fulvestrant, and abemaciclib – for people with hormone receptor-positive (HR+) and HER2-negative (HER2-) metastatic breast cancer. This includes those newly diagnosed with advanced or metastatic disease, or those whose cancer has returned more than 12 months after previous treatment. The study aims to see how many participants respond to this treatment combination. To join, you must have HR+ breast cancer, meaning your cancer cells have specific hormone receptors (ER or PgR). The study plans to enroll 20 participants.
- Study design
- This is a Phase 2, open-label (meaning you and your doctors will know what treatment you are receiving), single-arm study involving 20 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main goal of the study is measured at 3 months after treatment.
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NCT05524584
Anastrazole, Fulvestrant & Abemaciclib for HR+HER2- Metastatic Breast Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of California, IrvineInvestigator-initiated
~20 participants
Updated 2026-03-11 on ClinicalTrials.gov
What's tested:FulvestrantAnastrozoleAbemaciclib
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR)
Measured over Assessed at 3 months after study treatment
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Rita Mehta, MD · PRINCIPAL_INVESTIGATOR · Chao Family Comprehensive Cancer Center
Who to contact
Chao Family Comprehensive Cancer Center University of California, Irvine
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Eligibility criteria
Inclusion
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
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.
Have at least one measurable disease as defined per RECIST 1.1
Adequate organ and marrow function as defined below:
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.
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:
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.
Exclusion
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.
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
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.
What this trial measures
- Objective Response Rate (ORR)Assessed at 3 months after study treatment
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.