Clinical trial NCT05433753: Asian Multicenter Prospective Study in HER2 Positive Early Breast Cancer for Detecting MRD by ctDNA;HARMONY Study
Official title: Asian Multicenter Prospective Study in HER2 Positive Early Breast Cancer for Detecting Minimal Residual Disease by Circulating Tumor DNA Analysis With Neoadjuvant Chemotherapy; HARMONY Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HER2-positive Breast Cancer
Lead sponsor: National Cancer Center, Japan
Sponsor class: OTHER_GOV
First posted: 2022-06-27
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HER2-positive early breast cancer patients who have scheduled for neoadjuvant chemotherapy followed by surgery.

Brief summary: This study will assess minimal residual disease (MRD) in HER2-positive early breast cancer patients in Asian countries. The purpose is to evaluate the relation between the detection rate of MRD and recurrence.

Detailed description: This study will evaluate the relation between the detection rate of minimal residual disease(MRD) and recurrence in HER2-positive early breast cancer patients in Asian countries. Blood will be regularly collected to check the presence of ctDNA in HER2-positive breast cancer patients who have scheduled for neoadjuvant chemotherapy followed by surgery. Prognostic data is also collected on the same patients.

MRD is a small number of cancer cells left in the body during or after treatment. These cells have the potential to cause recurrence in cancer patients. MRD detection can help identify patients at increased risk of disease recurrence and guide treatment decisions. However, limited data are available on when ctDNA analysis should be done in the course of treatment, and what is the appropriate analysis method. This study will contribute to determining whether MRD detection using ctDNA is useful to predict the recurrence of HER2-positive early breast cancer patients. If this can be proven, it is expected that detection of MRD can use as a biomarker to assist in the de-/escalation of treatment strategies, therefore allowing to avoid overtreatment in patients at low risk, and to add more intensive treatment in patients at high risk. Moreover, studying with Asian countries, the results will become the basic data for approval of liquid biopsy.

Eligibility criteria: Inclusion Criteria:

1. Age of 20 years or older at the date of registration.
2. Histological diagnosis of HER2-positive invasive breast carcinoma.
3. Patients scheduled for neoadjuvant chemotherapy followed by surgery.
4. Clinical Stage IIA-IIIC.
5. Known hormone receptor status.
6. Signed informed consent.

Exclusion Criteria:

1. Any other malignancy within 5 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the esophagus, stomach, colon, or cervix.
2. Bilateral synchronous breast cancer.
3. History of breast cancer.
4. Pregnancy at registration.

Primary outcomes:
measure: Invasive disease-free survival (IDFS)
timeFrame: The duration from the date of surgery until the date of first documented the IDFS events, whichever comes first, up to 3 years.
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: The duration from the date of surgery until the date of death from any cause, up to 3 years.
measure: Disease-free survival (DFS)
timeFrame: The duration from the date of surgery until the date of first documented the DFS events, whichever comes first, up to 3 years.
Other outcomes:
Locations:
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital, Japan
state: Tokyo
Study officials:
affiliation: Department of Medical Oncology, National Cancer Cancer Hospital
name: Sho Shiino, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: