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

ConditionHER2-positive Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorNational Cancer Center, Japan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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

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.

Secondary outcomes

1

Overall survival (OS)

Death attributable to any cause

Time frame
The duration from the date of surgery until the date of death from any cause, up to 3 years.
2

Disease-free survival (DFS)

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

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.

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

National Cancer Center Hospital, JapanRecruiting104-0045, Chuo-ku, TokyoJapanJapan

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Center, Japan

Lead sponsor

Source ClinicalTrials.gov
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