Cohort study of treatment strategy for low risk HER2 positive breast cancer based on response-guided therapy and shared decision making

Cohort study of treatment strategy for low risk HER2 positive breast cancer based on response-guided therapy and shared decision making - HERREST study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000050326

Enrollment

100

Registered

2023-03-01

Start date

2023-02-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER2 positive breast cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Histologically diagnosed invasive cancer that has not been treated in any way 2) 1cm =<cT =< 3cm, cN0 3) Women between 20 and 80 years of age 4) HER2 positive breast cancer IHC 3 plus or FISH amplification 5) The latest laboratory values within 4 weeks prior to enrollment meet all of the following 1 Neutrophil count >=1500/mm3 or white blood cell count >= 3000/mm3 2 Hemoglobin >= 8.0 g/dl 3 Platelet count >=100000/mm3 4 Total bilirubin =< less than twice the institutional standard 5 AST or ALT =< 2.5 times or less than the institutional standard 6 Creatinine =< 2.0 mg/dL 6) Left ventricular ejection fraction >50% on the most recent echocardiography 7) PS, 0-2

Exclusion criteria

Exclusion criteria: 1) Concurrent bilateral breast cancer, multiple ipsilateral breast cancers of different subtypes 2) History of breast cancer, active overlapping cancers, history of allergies that would result in protocol interruption 3) History of serious cardiac disease (heart failure, myocardial infarction, ischemic disease, vascular disease requiring treatment) 4) Difficulty in continuing hospital visits due to physical inactivity 5) Complicated mental illness or psychiatric symptoms that make participation in the study difficult 6) In case the attending physician determines that the subject is not suitable for participation in the study

Design outcomes

Primary

Measure	Time frame
Disease-free survival for all prospective study subjects	—

Secondary

Measure	Time frame
Pathological evaluation by each subgroup OS for all prospective study subjects DFS,OS for each subgroup Final percentage of patients who did not receive EC Adverse events overall and by each subgroup Treatment response of each regimen Clinical response especially for taxane and anti-HER2 therapy Actual results of SDM and the reasons for their decisions Patient and medical staff with the process of response-guided therapy Qualitative evaluation of SDM in response-guided therapy	—

Measure

Time frame

Pathological evaluation by each subgroup OS for all prospective study subjects DFS,OS for each subgroup Final percentage of patients who did not receive EC Adverse events overall and by each subgroup Treatment response of each regimen Clinical response especially for taxane and anti-HER2 therapy Actual results of SDM and the reasons for their decisions Patient and medical staff with the process of response-guided therapy Qualitative evaluation of SDM in response-guided therapy

—

Countries

Japan

Contacts

Public ContactNoriko Fujita

Osaka Breast Clinic Department of Breast and Endocrine Surgery

noriko_f_0505@yahoo.co.jp06-6465-4108

Outcome results