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.


Study is Available At:


Original ID:

J1836


NCT ID:

NCT03573648


Secondary ID:

IRB00164275


Study Acronym:

ImmunoADAPT


Brief Title:

Neoadjuvant Tamoxifen, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer


Official Title:

A Pilot Study of IMMUNe mOdulation in Early Stage Estrogen Receptor Positive Breast Cancer Treated With neoADjuvant Avelumab, Palbociclib, and Tamoxifen: The ImmunoADAPT Study


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Cesar A. Santa-Maria, MD, MSCI
Principal Investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Primary Contact:Hopkins Breast Trials
410-614-1361
hopkinsbreasttrials@jhmi.edu
Backup Contact:Sidney Kimmel Cancer Center Clinical Research Office
410-955-8866
jhcccro@jhmi.edu

Study Dates

Start Date:November 13, 2018
Completion Date:August 2020
Completion Type:Anticipated
Primary Completion Date:August 2020
Primary Completion Type:Anticipated
Verification Date:August 2019
Last Changed Date:August 29, 2019
First Received Date:June 20, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Safety and Tolerability as determined by number of patients who experience Adverse Events
Time Frame:2 years
Safety Issues:False
Description:Adverse events will be assessed by CTCAE at each treatment visit and 30 days after completion of therapy.
Outcome Type:Primary Outcome
Measure:Clinical Complete Response
Time Frame:2 years
Safety Issues:False
Description:The number of patients with a response to treatment as assessed by MRI breast imaging

Study Interventions

Intervention Type:Drug
Name:Avelumab
Description:Avelumab (10 mg/kg) will be given intravenously on cycles 2 - 4, every 2 weeks.
Arm Name:Tamoxifen
Other Name:Bavencio
Intervention Type:Drug
Name:Tamoxifen
Description:Tamoxifen (20 mg) will be given orally daily x 4 cycles
Arm Name:Tamoxifen
Other Name:Nolvadex
Intervention Type:Drug
Name:Palbociclib
Description:Palbociclib (125 mg) will be given orally on days 1-21 of each cycle x 4 cycles.
Arm Name:Tamoxifen with Palbociclib
Other Name:Ibrance

Study Arms

Study Arm Type:Active Comparator
Arm Name:Tamoxifen
Description:Eligible patients with ER-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 Arm Type:Active Comparator
Arm Name:Tamoxifen with Palbociclib
Description:Eligible patients with ER-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 Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


If you would like to be contacted by the clinical trial representative please fill out the form below.