Personalized Detection of ctDNA for Patients With HER2-Positive Metastatic Breast Cancer Who Achieved Durable Response by Anti-HER2 Treatment (HER2 CR)

NCT06663787 | Active Not Recruiting FDA Device

• 2 other identifiers: HER2 CR80-24-0057
• Study Type: observational
• Target: 50
• Locations: 2 countries
• Sites: 4

Brief Summary

Anti-HER2 therapy, such as trastuzumab and pertuzumab, has significantly improved long-term survival in HER2-positive breast cancer. The updated data of the CLEOPATRA trial showed significant Kaplan-Meier curves, suggesting the potential for a cure. However, the efficacy of maintenance therapy in long-term responders remains unexplored. This study will assess MRD in unresectable HER2-positive breast cancer cases with long-term response using the Signatera™ ctDNA assay, which could contribute to future treatment strategy development.

Conditions

HER2 + Breast Cancer; Breast Cancer, Metastatic

Keywords

ctDNA monitoring; MRD; minimal residual disease; HER2+ breast cancer; Dual response

Outcome Measures

Primary Outcomes (1)

• The status of ctDNA

  To assess the status of ctDNA in CR patients with/without continuing treatment, or PR patients with continuing treatment

  1 year

Study Arms (2)

Continuing anti-HER2 treatment

Breast cancer patients who are continuing complete response (CR) or partial response (PR) for more than two years of anti-HER2 treatment (trastuzumab, pertuzumab, T-DM1, and T-DXd)

Drug: Trastuzumab (Herceptin); Diagnostic Test: SIgnatera

Follow up (stop anti-HER2 treatment)

Breast cancer patients who stopped anti-HER2 treatment with complete response (CR) or partial response (PR) after more than two years of anti-HER2 treatment(trastuzumab, pertuzumab, T-DM1, and T-DXd)

Diagnostic Test: SIgnatera

Interventions

Trastuzumab (Herceptin) DRUG

Continuing anti-HER2 treatment

Also known as: Trastuzumab Emtansine, Trastuzumab Deruxtecan

Continuing anti-HER2 treatment

SIgnatera DIAGNOSTIC_TEST

A personalized, tumor-informed test.

Continuing anti-HER2 treatment; Follow up (stop anti-HER2 treatment)

Eligibility Criteria

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

Study Population

The eligibility criteria for this study include patients who have been diagnosed with histologically confirmed invasive breast cancer and unresectable HER2-positive breast cancer. Eligible cases are those in which drug therapy, including anti-HER2 therapy, was initiated between January 1, 2000, and December 31, 2021. Additionally, patients must have maintained a partial or complete response to drug therapy, including anti-HER2 therapy, for more than two years. Finally, the study is limited to female patients aged 20 years or older.

You may qualify if:

• HER2 + metastatic breast cancer
• Pre / post menopausal
• Previously treated with anti-HER2 therapy
• Continuing CR or PR for more than 2 year

You may not qualify if:

• Patients who were deemed inappropriate as research subjects based on the physician's judgment, such as those possibly receiving inappropriate treatment.

Sponsors & Collaborators

• Nagoya City University: lead

Study Sites (4)

Natera

San Carlos, Texas, 94070, United States

Location

Aichi Cancer Center

Nagoya, Aichi-ken, 4678601, Japan

Location

Nagoya City University

Nagoya, Aichi-ken, 4678601, Japan

Location

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Tokyo, Tokyo, 135-8550, Japan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue and blood samples

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis; Neoplasm, Residual

Interventions

Trastuzumab; Ado-Trastuzumab Emtansine; trastuzumab deruxtecan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Maytansine; Macrolides; Lactones; Organic Chemicals; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 29, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1); JP (3)