STOP-HER2: Stopping Trastuzumab in HER2+ MBC
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ClinicalTrials.gov Identifier: NCT05721248 |
Recruitment Status :
Recruiting
First Posted : February 9, 2023
Last Update Posted : January 5, 2024
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Condition or disease | Intervention/treatment | Phase |
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Breast Cancer Metastatic Breast Cancer HER2-positive Breast Cancer | Other: Cessation of anti-HER2 treatment | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 82 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The STOP-HER2 Trial: A Phase 2 Study of Stopping Trastuzumab - Outcomes in Patients With HER2+ Metastatic Breast Cancer |
Actual Study Start Date : | April 19, 2023 |
Estimated Primary Completion Date : | February 2026 |
Estimated Study Completion Date : | February 2036 |
Arm | Intervention/treatment |
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No Intervention: Cohort 1: Observational Continue Anti-HER2 Therapy
Participants will have scans 30 days prior to starting study then undergo clinical follow-up 4-6 weeks after study initiation, at 12 weeks, and every 12 weeks thereafter. Visits will include interval history, physical exam, concomitant medications and blood draw for tumor marker assessment and research blood. Participants will undergo restaging scans every 12 weeks (+/- 2 weeks). |
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Experimental: Cohort 2: - Stop Anti-HER2 Therapy
Participants will have scans 30 days prior to starting study. Week 1 participants will stop anti-HER2 therapy then undergo clinical follow-up every 4-6 weeks, at 12 weeks, and every 12 weeks thereafter. Visits will include interval history, physical exam, concomitant medications and blood draw for tumor marker assessment and research blood. Participants will undergo restaging scans every 12 weeks (+/- 2 weeks). Participants remaining progression-free after one year off treatment, may continue off anti-HER2 therapy indefinitely, with imaging surveillance suggested to be every 3-6 months at the discretion of the treating oncologist and will be followed up to 10 years Participants with disease progression after stopping anti-HER2 therapy, treatment is at discretion of the treating physician but resuming the pre-study regimen is strongly encouraged. |
Other: Cessation of anti-HER2 treatment
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. |
- 1-year progression-free survival (PFS) Stopped Anti-HER2 Treatment [ Time Frame: Up to 1 year ]The primary endpoint is one-year progression-free survival (PFS) per RECIST 1.1 assessed separately in the participants who agree to stop HER2 therapy and those who continue HER2 therapy.
- 1-year progression-free survival (PFS) Continued Anti-HER2 Treatment [ Time Frame: Up to 1 year ]The primary endpoint is one-year progression-free survival (PFS) per RECIST 1.1 assessed separately in the participants who agree to stop HER2 therapy and those who continue HER2 therapy.
- Clinical benefit rate (CBR) [ Time Frame: Up to 1 year ]Determine the clinical benefit rate (CBR) of re-initiation of anti-HER2 therapy for participants who experience disease progression after stopping anti-HER2 therapy. Clinical benefit rate is defined as CR, PR, or SD ≥ 24weeks per RECIST 1.1. Clinical benefit rate after re-initiation of HER2 therapy will be reported with a 95% exact confidence interval.
- 3-year Overall survival (OS) [ Time Frame: Up to 3 years ]Determine 3-year overall survival (OS) in participants in cohorts 1 and 2 using time-to-event analysis methods of Kaplan-Meier
- 3-year progression-free survival (PFS) [ Time Frame: Up to 3 years ]Determine 3-year PFS in participants in cohorts 1 and 2 using time-to-event analysis methods of Kaplan-Meier.
- Probability of restarting anti-HER2 Treatment [ Time Frame: Up to 1 year ]Proportion of participants that restart anti-HER2 systemic therapy without progression of disease in participants stopping anti-HER2 therapy will be reported with a 95% exact confidence interval.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
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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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05721248
Contact: Heather A Parsons, MD, MPH | (617) 632-3800 | Heather_parsons@dfci.harvard.edu |
United States, District of Columbia | |
Georgetown University Medical Center | Recruiting |
Washington, District of Columbia, United States, 02809 | |
Contact: Elaine Walsh, MD elaine.m.walsh@gunet.georgetown.edu | |
Principal Investigator: Elaine Walsh, MD | |
United States, Massachusetts | |
Dana-Farber Cancer Insitute | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Heather A Parsons, MD, MPH 617-632-3800 Heather_parsons@dfci.harvard.edu | |
Principal Investigator: Heather A Parsons, MD, MPH | |
DFCI @ Foxborough | Recruiting |
Foxboro, Massachusetts, United States, 02035 | |
Contact: Natalie Sinclair, MD nsinclair1@partners.org | |
Principal Investigator: Natalie Sinclair, MD | |
DFCI @ Merrimack Valley | Recruiting |
Methuen, Massachusetts, United States, 01844 | |
Contact: Pedro Sanz-Altamira, MD Pedro_Sanz-Altamira@DFCI.HARVARD.EDU | |
Principal Investigator: Pedro Sanz-Altamira, MD | |
DFCI @ Milford Regional Hospital | Recruiting |
Milford, Massachusetts, United States, 01757 | |
Contact: Natalie Sinclair, MD nsinclair1@partners.org | |
Principal Investigator: Natalie Sinclair, MD | |
DFCI @ South Shore Hospital | Recruiting |
South Weymouth, Massachusetts, United States, 02190 | |
Contact: James Stoeckle, MD James_Stoeckle@dfci.harvard.edu | |
Principal Investigator: James Stoeckle, MD | |
United States, North Carolina | |
Duke University | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Susan Dent, MD susan.dent@duke.edu | |
Principal Investigator: Susan Dent, MD | |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Adam Brufsky, MD brufskyam@upmc.edu | |
Principal Investigator: Adam Brufsky, MD | |
United States, Texas | |
Baylor College of Medicine | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Ahmed Elkhanany, MD aelkhanany@uabmc.edu | |
Principal Investigator: Ahmed Elkhanany, MD |
Principal Investigator: | Heather A Parsons, MD, MPH | Dana-Farber Cancer Institute |
Responsible Party: | Heather A. Parsons, MD, Principal Investigator, Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT05721248 |
Other Study ID Numbers: |
22-655 1K08CA252639-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | February 9, 2023 Key Record Dates |
Last Update Posted: | January 5, 2024 |
Last Verified: | January 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
Time Frame: | Data can be shared no earlier than 1 year following the date of publication |
Access Criteria: | Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Breast Cancer Metastatic Breast Cancer HER2-positive Breast Cancer |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |