Asian Multicenter Prospective Study in HER2 Positive Early Breast Cancer for Detecting MRD by ctDNA;HARMONY Study

NCT05433753 | Recruiting

• 1 other identifier: NCCH2113
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Invasive disease-free survival (IDFS)

  ipsilateral invasive breast cancer recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer

  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 (2)

• Overall survival (OS)

  The duration from the date of surgery until the date of death from any cause, up to 3 years.

• Disease-free survival (DFS)

  The duration from the date of surgery until the date of first documented the DFS events, whichever comes first, up to 3 years.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HER2-positive early breast cancer patients who have scheduled for neoadjuvant chemotherapy followed by surgery.

You may qualify if:

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

You may not qualify if:

• 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.
• Bilateral synchronous breast cancer.
• History of breast cancer.
• Pregnancy at registration.

Sponsors & Collaborators

• National Cancer Center, Japan: lead

Study Sites (1)

National Cancer Center Hospital, Japan

Chuo-ku, Tokyo, 104-0045, Japan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, tissue

Study Officials

• Sho Shiino, MD, PhD

  Department of Medical Oncology, National Cancer Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuki Kojima, MD, PhD

CONTACT

0335422511; yuukojim@ncc.go.jp

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 27, 2022
• Study Start: May 24, 2022
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 25, 2024

Record last verified: 2024-03

Locations

JP (1)