A phase III, randomized, open-label study to compare pharmacokinetics, efficacy and safety of subcutaneous (SC) trastuzumab with intravenous (IV) trastuzumab administered in women with HER2 positive early breast cancer (EBC).

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 552

Inclusion Criteria

1.Patients must have signed and dated an informed consent form
2.Female
3.Age = 18 years
4.Non-metastatic primary invasive adenocarcinoma of the breast which is clinical stage I (T1, N0, M0) to IIIC (any T, N3, M0) including inflammatory and multicentric breast cancer
a.with tumor size = 1 cm
b.histologically confirmed
c.centrally confirmed HER2 positive (IHC3+ or ISH+) in the invasive component of the primary tumor
5.At least one measurable lesion in breast or lymph nodes, according to RECIST v1.0 criteria, except for inflammatory carcinoma (T4d)
6.Performance status ECOG of 0-1
7.Baseline LVEF = 55% measured by echocardiography or MUGA scan prior to first dose of trastuzumab

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.History of any prior (ipsi- and/or contralateral) invasive breast carcinoma
2.Past or current history of malignant neoplasms, except for curatively treated:
a.Basal and squamous cell carcinoma of the skin
b.in situ carcinoma of the cervix
3.Metastatic disease
4.Any prior therapy with anthracyclines
5.Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy
6.Concurrent anti-cancer treatment in another investigational trial, including immunotherapy
7.Patients with severe dyspnoea at rest or requiring supplementary oxygen therapy, patients with other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions/illness
8.Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented CHF, high-risk uncontrolled arrhythmias, angina pectoris requiring medication , clinically significant valvular disease, evidence of transmural infarction on ECG, poorly controlled hypertension
9.Medical conditions that would preclude the use of 5-fluorouracil, epirubicin, cyclophosphamide or docetaxel, including: cystitis, urinary obstruction, active infections or severe mucositis
10.History of severe allergic and immunological reactions, e.g. difficult to control asthma
11.Known hypersensitivity to any of the study drugs or any of the excipients, known hypersensitivity to murine proteins
12.Known dihydropyrimidine dehydrogenase (DPD) deficiency
13.Any of the following abnormal laboratory tests at baseline:
a.Biochemistry:
i.serum total bilirubin > 1.25 x upper limit of normal (ULN)
ii.alanine amino transferase (SGPT, ALT) or aspartate amino transferase (SGOT, AST) > 2.5 x ULN
iii.alkaline phosphatase (ALP) > 2.5 x ULN
iv.serum creatinine > 1.5 x ULN;
b.Hematology:
i.absolute neutrophil count (ANC) < 1.5 x 10e9/L
ii.platelets < 100 x 10e9/L
iii.haemoglobin < 10 g/dl
14.Pregnant or lactating women
15.Women of childbearing potential or less than one year after menopause (unless surgically sterile) who are unable or unwilling to use adequate contraceptive measures during study treatment
16.Patients unwilling or unable to comply with protocol procedures

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

A Study to Compare Subcutaneous Versus Intravenous Administration of Herceptin (Trastuzumab) in Women With HER2Positive Early Breast Cancer

Phase 1

F. Hoffmann-La Roche Ltd

Updated 1/24/2022