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

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

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.

Study Overview

• Status: Recruiting
• Conditions: HER2-positive Breast Cancer

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Yuki Kojima, MD, PhD; Phone Number: 0335422511; Email: yuukojim@ncc.go.jp

Study Locations

• Japan
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • Recruiting
      • National Cancer Center Hospital, Japan
      • Contact: Shiino Sho, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	Death attributable to any cause	The duration from the date of surgery until the date of death from any cause, up to 3 years.
Disease-free survival (DFS)	IDFS events, ipsilateral or contralateral DCIS, second primary non-breast invasive cancer	The duration from the date of surgery until the date of first documented the DFS events, whichever comes first, up to 3 years.

Collaborators and Investigators

• Sponsor: National Cancer Center, Japan
• Collaborators: H.U. Group Research Institute G.K.
• Investigators: Principal Investigator: Sho Shiino, MD, PhD, Department of Medical Oncology, National Cancer Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2022
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: NCCH2113

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No