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NCT Number: NCT05433753

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

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Key information

Conditions

HER2-positive Breast Cancer

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cancer Center Hospital, Japan

Chuo-ku, Tokyo, 104-0045, Japan

Location status: Recruiting

Location contact

Shiino Sho, MD,PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Invasive disease-free survival (IDFS)

    Time frame: The duration from the date of surgery until the date of first documented the IDFS events, whichever comes first, up to 3 years.

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

Secondary outcomes

  1. Overall survival (OS)

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

    Death attributable to any cause

  2. Disease-free survival (DFS)

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

    IDFS events, ipsilateral or contralateral DCIS, second primary non-breast invasive cancer

Study contacts

Contact information is provided by the study sponsor or research team.

Yuki Kojima, MD, PhD

CONTACT

[email protected]

0335422511

Sponsors and collaborators

Lead sponsor

National Cancer Center, Japan

Other Gov

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jun 27, 2022
Registry last updated
Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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