Trial Title:
STOP-HER2: Stopping Trastuzumab in HER2+ MBC
NCT ID:
NCT05721248
Condition:
Breast Cancer
Metastatic Breast Cancer
HER2-positive Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast Cancer
Metastatic Breast Cancer
HER2-positive Breast Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Cessation of anti-HER2 treatment
Description:
Cessation of anti-HER2 treatment with standard treatment described as trastuzumab
(Herceptin) with or without pertuzumab (Perjeta) continued as long as it is working or
significant side effects occur.
Arm group label:
Cohort 2: - Stop Anti-HER2 Therapy
Summary:
This study is being done to see if anti-HER2 treatment be safely stopped in patients with
HER2-positive metastatic breast cancer (MBC) that have had exceptional response to
treatment. Exceptional response" is considered as cancer progression being controlled for
three years or more since starting anti-HER2 treatment.
Detailed description:
This is a single arm, phase II study of cessation of anti-HER2 systemic therapy in
exceptional responders with HER2-positive metastatic breast cancer (MBC), defined as
individuals free of disease progression after at least 3 years of first-line treatment.
This research study will include two different groups (cohorts) of patients. Those not
wanting to stop anti-HER2 maintenance treatment will be included in a non-randomized,
observational cohort (cohort 1). Those willing to stop maintenance anti-HER2 treatment
you will be included in cohort 2.
This study is trying to understand whether blood samples that may contain traces of DNA
from cancer, known as "circulating tumor DNA" or "ctDNA" are able to help identify which
patients can successfully stop treatment without a change in their cancer.
The research study procedures include: an initial screening phase followed by periodic
visits with blood work, questionnaires, and body scans.
It is expected that about 82 people will take part in this research study (52 in cohort 2
(stopping treatment), 30 in cohort 1 (continuing treatment). This study is expected to
last 1 year with 10 years of follow up.
The Susan G. Komen Foundation, the Gateway for Cancer Research - both nonprofit
foundations supporting cancer research - and the National Institutes of Health are
supporting this research study by providing funds. This study is also being supported by
Johns Hopkins University on behalf of the Translational Breast Cancer Research Consortium
(TBCRC). The TBCRC is a group of academic medical centers across the United States that
work together to conduct breast cancer research.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age ≥18 years
- Participants must have histologically or cytologically confirmed unresectable
locally advanced or metastatic invasive breast carcinoma that is HER2-positive by
American Society of Clinical Oncology/College of American Pathologists 2018
criteria, as assessed by standard institutional guidelines (central testing is not
required). Both estrogen receptor (ER)-positive/HER2-positive and
ER-negative/HER2-positive will be eligible.
- Participants with ER-positive disease should continue endocrine therapy.
- Participants must be currently receiving first-line anti-HER2 therapy (any regimen)
for metastatic disease and must have been on this therapy for at least 3 years
without evidence of progressive disease according to RECIST 1.1 criteria. The
following exceptions apply:
- Patients with history of brain-only progressive disease previously treated with
local therapy (surgery and/or radiation therapy) are eligible, provided they meet
all the following study criteria:
- Asymptomatic
- Not requiring anti-convulsant for symptomatic control
- Not requiring corticosteroids
- No evidence of interim central nervous system (CNS) progression between the
completion of CNS-directed therapy and screening radiographic study
- Minimum of 2 years (24 months) between completion of CNS-directed therapy and
study start
- Participants with history of oligo-progression (i.e., progressive disease of a
single lesion) outside CNS treated with local treatment and/or change of endocrine
therapy only are eligible, provided they meet the following criteria:
- No evidence of interval progression between completion of local treatment or
endocrine therapy change and screening radiographic study
- Minimum 2 years (24 months) between completion of local therapy or treatment
switch and study start
- CT scan within 30 days of study start without definite evidence of progressive
disease in the opinion of the treating investigator.
- Available, representative archival formalin-fixed paraffin-embedded (FFPE) tumor
tissue block from primary and/or metastatic site. If tissue block is unavailable, 20
unstained 10uM slides will be accepted (less than 20 slides may be acceptable with
documentation of Sponsor-Investigator approval and would not require an eligibility
exception). Tumor tissue must be received by coordinating site prior to study
enrollment.
- ECOG performance status 0-1
- For intervention arm only (cohort 2): willingness to stop anti-HER2 systemic therapy
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory
tests, and other study procedures
- Ability to understand the study requirements and document informed consent
indicating awareness of the investigational nature and the risks of this study
- Participants with another prior or concurrent malignancy whose natural history or
treatment does not have the potential to interfere with the safety or efficacy
assessment of this trial are eligible
Exclusion Criteria:
- Participants who are receiving any investigational agents to treat breast cancer
- Participants with psychiatric illness/social situations that would limit compliance
with study requirements.
- All English- speaking patients will participate in the PRO measures. Patients that
do not read or understand English are eligible to participate but will be exempt
from the patient completed questionnaires
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic Hospital Arizona
Address:
City:
Phoenix
Zip:
85054
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brenda Ernst, MD
Email:
ernst.brenda@mayo.edu
Contact backup:
Last name:
Brenda Ernst, MD
Facility:
Name:
Georgetown University Medical Center
Address:
City:
Washington
Zip:
02809
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elaine Walsh, MD
Email:
elaine.m.walsh@gunet.georgetown.edu
Contact backup:
Last name:
Elaine Walsh, MD
Facility:
Name:
Mayo Clinical Hospital Florida
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Saranya Chumsri, MD
Email:
chumsri.saranya@mayo.edu
Contact backup:
Last name:
Saranya Chumsri, MD
Facility:
Name:
Dana-Farber Cancer Insitute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Heather A Parsons, MD, MPH
Phone:
(617) 632-3800
Email:
Heather_parsons@dfci.harvard.edu
Contact backup:
Last name:
Heather A Parsons, MD, MPH
Facility:
Name:
DFCI @ Foxborough
Address:
City:
Foxborough
Zip:
02035
Country:
United States
Status:
Recruiting
Contact:
Last name:
Natalie Sinclair, MD
Email:
nsinclair1@partners.org
Contact backup:
Last name:
Natalie Sinclair, MD
Facility:
Name:
DFCI @ Merrimack Valley
Address:
City:
Methuen
Zip:
01844
Country:
United States
Status:
Recruiting
Contact:
Last name:
Pedro Sanz-Altamira, MD
Email:
Pedro_Sanz-Altamira@DFCI.HARVARD.EDU
Contact backup:
Last name:
Pedro Sanz-Altamira, MD
Facility:
Name:
DFCI @ Milford Regional Hospital
Address:
City:
Milford
Zip:
01757
Country:
United States
Status:
Recruiting
Contact:
Last name:
Natalie Sinclair, MD
Email:
nsinclair1@partners.org
Contact backup:
Last name:
Natalie Sinclair, MD
Facility:
Name:
DFCI @ South Shore Hospital
Address:
City:
South Weymouth
Zip:
02190
Country:
United States
Status:
Recruiting
Contact:
Last name:
James Stoeckle, MD
Email:
James_Stoeckle@dfci.harvard.edu
Contact backup:
Last name:
James Stoeckle, MD
Facility:
Name:
Mayo Clinic Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ciara O'Sullivan, M.B., B.Ch.
Email:
osullivan.ciara@mayo.edu
Contact backup:
Last name:
Ciara O'Sullivan, M.B., B.Ch.
Facility:
Name:
Duke University
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Contact:
Last name:
Susan Dent, MD
Email:
susan.dent@duke.edu
Contact backup:
Last name:
Susan Dent, MD
Facility:
Name:
University of Pittsburgh Medical Center
Address:
City:
Pittsburgh
Zip:
15213
Country:
United States
Status:
Recruiting
Contact:
Last name:
Adam Brufsky, MD
Email:
brufskyam@upmc.edu
Contact backup:
Last name:
Adam Brufsky, MD
Facility:
Name:
Baylor College of Medicine
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ahmed Elkhanany, MD
Email:
aelkhanany@uabmc.edu
Contact backup:
Last name:
Ahmed Elkhanany, MD
Facility:
Name:
Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Last name:
William Gwin, MD
Email:
wgwin@fredhutch.org
Contact backup:
Last name:
William Gwin, MD
Start date:
April 19, 2023
Completion date:
February 2036
Lead sponsor:
Agency:
Dana-Farber Cancer Institute
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
Gateway for Cancer Research
Agency class:
Other
Collaborator:
Agency:
Susan G. Komen Breast Cancer Foundation
Agency class:
Other
Collaborator:
Agency:
Translational Breast Cancer Research Consortium
Agency class:
Other
Collaborator:
Agency:
Johns Hopkins University
Agency class:
Other
Source:
Dana-Farber Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05721248
