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Trial of Neoadjuvant Trastuzumab Emtansine in Patients With HER2-Equivocal Breast Cancer | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

Trial of Neoadjuvant Trastuzumab Emtansine in Patients With HER2-Equivocal Breast Cancer

NCT02725541•Jenny C. Chang, MD

View on ClinicalTrials.gov

Summary

This is an open label, neoadjuvant phase II study to evaluate the objective response, toxicity, and safety of trastuzumab emtansine in patients with newly diagnosed HER2-equivocal breast cancer. Trastuzumab emtansine at a dose of 3.6 mg/kg will be intravenously administered every 3 weeks for a total of 6 weeks. Patients who achieve a partial or complete response after the 6-week treatment (responders) will continue on trastuzumab emtansine for an additional 12 weeks.

Detailed Description

NATURE is an open label, neoadjuvant, phase II study designed to evaluate the objective response rate of trastuzumab emtansine in patients with newly diagnosed HER2-equivocal breast cancer. Patients will receive trastuzumab emtansine at a dose of 3.6 mg/kg via intravenous infusion every 3 weeks for a total of 6 weeks (2 21-day cycles). Patients who achieve partial or complete response (responders) after the 6-week treatment will continue on trastuzumab emtansine for an additional 12 weeks (4 cycles). The primary objective will be objective response rate after 6 weeks of neoadjuvant trastuzumab emtansine. Secondary objectives will include imaging response (ultrasound and magnetic resonance imaging) after six weeks of neoadjuvant trastuzumab emtansine and toxicity and efficacy of trastuzumab emtansine. After completion of continued trastuzumab emtansine treatment, pathological complete response rate of responders as a whole and according to estrogen receptor status will be explored. Markers related to the mechanism of action of trastuzumab emtansine (HER2 copy number in circulating tumor cells; tissue expression of PTEN, PI3K, and other potential candidate markers) will also be explored.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Female gender;
•Age ≥18 years;
•Eastern Cooperative Oncology Group performance status of 0-1;
•Histologically confirmed invasive breast cancer;
•Primary tumor greater than or equal to 1 cm diameter, as measured by clinical examination and mammography or ultrasound;
•Any N;
•No evidence of metastasis (M0) (isolated supra-clavicular node involvement allowed);
•HER2 low or equivocal status in the invasive component of the primary tumor (confirmed by a central certified laboratory prior to study entry)
•* HER2 low expression: 1+/2+ by immunohistochemistry and/or HER2/CEP17 ratio \<2.0 with HER2 copy number \<6.0 signals/cell
•* HER2 equivocal expression: HER2 copy number ≥4.0 and \<6.0 signals/cell;
+9 more criteria

Exclusion Criteria

•Previous (less than 5 years) or current history of malignant neoplasms, except for curatively treated basal and squamous cell carcinoma of the skin and carcinoma in situ of the cervix;
•Patients with a prior malignancy diagnosed more than 5 years prior to study entry;
•Preexisting peripheral neuropathy ≥ grade 2;
•Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension (≥180/110), unstable diabetes mellitus, dyspnea at rest, or chronic oxygen therapy;
•Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical disorder that would interfere with the patient's safety;
•Unresolved or unstable serious adverse events from prior administration of another investigational drug;
•Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF;
•Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy other than the trial therapy);
•Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;
•Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trastuzumab emtansine or its components;
+6 more criteria

Locations (1)

Houston Methodist Hospital

Houston, Texas, United States

Key Dates

Start Date

March 1, 2016

Primary Completion Date

April 1, 2019

Completion Date

May 1, 2019

Last Updated

September 14, 2016

Conditions

Breast Cancer

Interventions

Trastuzumab emtansine

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 14, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Trial of Neoadjuvant Trastuzumab Emtansine in Patients With HER2-Equivocal Breast Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

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Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer