Baltimore, Maryland 21287


Purpose:

Eligible patients with estrogen receptor positive breast cancer will undergo a biopsy and be randomized to receive tamoxifen (T) versus tamoxifen with palbociclib (PT) in a 1:1 ratio. After 1 cycle (28 days) another biopsy will be obtained, and both arms will receive avelumab (A) for 3 additional cycles. Patients will then undergo breast surgery.


Study summary:

Patients will be treated with tamoxifen (20mg PO daily) +/- palbociclib (125mg PO daily for 21 days, 7 days off ) for 1 cycle (1 cycle =28 days) and undergo a repeat biopsy, MRI, and blood draw at Cycle 2, Day 1. Afterwards avelumab will be added to both arms. Avelumab will be administered 10mg/kg IV every 14 days (1 cycle = 2 doses = 28 days). Patients will be treated for 3 cycles of avelumab with tamoxifen +/- palbociclib (thus 4 cycles total, including run-in without avelumab). Patients will be treated so long as there is no clinical evidence of progression and therapy is tolerated. Patients who experience progressive disease (25% increase) of their tumor will cease study treatment and undergo end-of-study assessment (including repeat MRI) and surgery. Otherwise, patients completing all 4 cycles of therapy will undergo MRI and surgery.


Criteria:

Inclusion Criteria: - Stage II-III ER-positive breast cancer. - Age ≥ 18 years. - Eastern Cooperative Oncology Group performance status of 1 or less. - Adequate organ and bone marrow function within 28 days prior to registration. - Females of child-bearing potential and males must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 30 days following completion of therapy. - Females of child-bearing potential must have a negative pregnancy test within 7 days prior to registration on study. - Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study Exclusion Criteria: - Evidence of metastatic disease or inflammatory breast cancer. - Patients not felt to benefit from endocrine therapy (i.e. clinically aggressive presentation). - Previous treatment with endocrine therapy within the last 10 years (i.e. tamoxifen, aromatase inhibitors). - Previous treatment with CDK4/6 inhibitors, or immune checkpoint inhibitors. - May not be receiving any other investigational agents. - May not be receiving immunosuppressive therapy within 2 weeks of study entry. - History of allergic reactions attributed to compounds of similar chemical or biologic composition to tamoxifen, palbociclib, and avelumab are not eligible. - May not have had a prior diagnosis of cancer if it has been < 3 years since their last treatment (with the exception of squamous cell carcinoma or basal cell carcinoma of the skin or cervical intraepithelial neoplasia). NOTE: Patients with a history of breast cancer or breast cancer treatment within the last 10 years are also excluded. Any previous radiation to affected breast is excluded. - Autoimmune disease within the last 3 years with the exception of: Vitiligo or alopecia, Hypothyroidism on stable doses of thyroid medication, and Psoriasis not requiring systemic therapy - Uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible: Ongoing or active infection requiring systemic treatment (including HIV, TB, hepatitis viruses), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness/social situations that would limit compliance with study requirements, any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints - Female patients who are pregnant or nursing are not eligible.


NCT ID:

NCT03573648


Primary Contact:

Principal Investigator
Cesar A. Santa-Maria, MD, MSCI
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Hopkins Breast Trials
Phone: 410-614-1361
Email: hopkinsbreasttrials@jhmi.edu


Backup Contact:

Email: jhcccro@jhmi.edu
Sidney Kimmel Cancer Center Clinical Research Office
Phone: 410-955-8866


Location Contact:

Baltimore, Maryland 21287
United States

Hopkins Breast Trials
Email: HopkinsBreastTrials@jhmi.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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