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

Withdrawn before enrolling · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02725541

Run by

Jenny C. Chang, MD

People needed

0

Starts

2016-03-01

Expected to finish

2019-05-01

Last updated by the study team

2016-09-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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;
• Hematopoietic status:
• Absolute neutrophil count ≥ 1.0 x 10\^9/L, Platelet count ≥ 100 x 10\^9/L, Hemoglobin at least 9 g/dL;
• Hepatic status: Serum total bilirubin ≤1 x upper limit of normal (ULN; In the case of known Gilbert's syndrome, a higher serum total bilirubin [< 1.5 x ULN] is allowed), Aspartate aminotransferase and alanine aminotransferase ≤1.5 x ULN, Alkaline phosphatase ≤ 1.5 x ULN;
• Renal status: Creatinine ≤1.5 mg/dL;
• International Normalized Ratio ≤1.5 x ULN;
• Baseline left ventricular ejection fraction ≥50%, as measured by echocardiography or multigated acquisition scan;
• Negative serum or urine β-human chorionic gonadotropin pregnancy test within 7 days prior study entry for patients of childbearing potential. Women of childbearing potential must use effective contraception (barrier method [condoms, diaphragm] in conjunction with spermicidal jelly, or total abstinence. Oral, injectable, and implantable hormonal contraceptives are not allowed) for the duration of the study and for at least 7 months after the last dose of study treatment;
• Signed informed consent form (ICF);
• Patient accepts to make available tumor samples for submission to central laboratory to conduct translational studies as part of this protocol.

You may not qualify if…

• 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;
• Ejection fraction <55% or below the lower limit of the institutional normal range;
• Pregnant or lactating women;
• Concomitant use of cytochrome P450 3A4 inhibitors or inducers;
• Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol;
• Active infection requiring intravenous or oral antibiotics;
• Patients unwilling or unable to comply with the protocol.

Where it is running

• Houston Methodist Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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