Effect of Perioperative AntiHER2 Therapy on Early Breast Cancer Study - Biological Phase - EPHOS-B

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 250

Inclusion Criteria

• Women aged =18 years.
• HER2 positive (3+ on IHC or amplification proven by FISH*) operable invasive breast cancer diagnosed by core biopsy.
• Planned surgery within one month of diagnosis.
• Serum creatinine and bilirubin <2 times the upper limits of normal for the institution, or creatinine clearance >30mg/dL. (Marginally abnormal test results should be repeated).
• ECOG performance status 0, 1, or 2 (Karnofsky = 60%).
• Non pregnant and non-lactating with no intention of pregnancy during study treatment. Women of childbearing potential must agree to use adequate non-hormonal contraception for the duration of the treatment phase of the study (adequate contraceptive measures include intra-uterine device, barrier method e.g. diaphragm and condoms used in conjunction with spermicidal jelly). Women of childbearing potential must have a negative blood serum pregnancy test within 28 days prior to randomisation).
• Patients must be candidates for and willing to undergo adjuvant chemotherapy and trastuzumab post surgery.
• Written informed consent obtained for trial and to donation of tissue and blood samples.

* Details of how FISH cases should be categorised are included the protocol.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

• HER2 negative cancers and those with unknown HER2 status.
• Inoperable breast cancer (T4 category) or suspicion of distant metastases.
• Diagnosis of inflammatory breast cancer.
• Clinical evidence of metastatic disease.
• Prior herceptin therapy within the last 12 months or local (radiotherapy) cancer treatments.
• Previous cancer at any other site that has been treated within the last 6 months (except previous basal cell carcinoma and cervical carcinoma in situ)
• Have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones or stable chronic liver disease per investigator assessment).
• Impaired gastro-intestinal function thought sufficient to reduce lapatinib absorption.
• Contra-indicated to receive adjuvant chemotherapy and /or trastuzumab (ECOG >2).
• Known immediate or delayed hypersensitivity, reaction to drugs chemically related to trastuzumab or lapatinib.
• Other concomitant investigational agents or concurrent anti-cancer therapy.
• Use of herbal (alternative) therapies within 2 weeks of study entry.
(NB vitamin and / or mineral supplements are allowed).See Appendix 1 of the protocol.
• If patients are taking any of the prohibited medication as listed in Appendix 1 of the protocol.
• Regular use of systemic steroids or other agents that could influence study endpoints (inhaled steroids are allowed).
• Any altered mental state that would preclude obtaining written informed consent.
• Clinically significant cardiac abnormalities or uncontrolled hypertension.
• Previous myocardial infarction, heart failure, or significant angina. Cardiac function should be assessed by physical examination, ECG, and baseline LVEF should be =55% as measured by echocardiography or MUGA.

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

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