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.
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
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)
Single group
Fulvestrant
DrugGiven intramuscularly
Anastrozole
DrugGiven orally
Abemaciclib
DrugGiven orally
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.
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
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.
Overall survival
Time from first treatment to death from any cause
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.
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