The Myocet/Lapatinib Study. ICORG 10-03, V5

Conditions

• Her2 Positive Metastatic Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• non-pegylated liposomal doxorubicon (Myocet™) — DRUG
• Lapatinib (Tyverb™) — DRUG

Study Details

This study is a Phase I/II open label, multi-centre trial. Patients with HER2+ve metastatic breast cancer, following disease progression during, or after, treatment with trastuzumab and taxanes, will be treated with Lapatinib (Tyverb™ 500-1250 mg orally daily - depending on the maximum tolerated dose (MTD) determined in the Phase I part of the study) plus Myocet™, 50-60 mg/m2 i.v q3 weeks). Within the Phase I part, doses are assigned at registration according to the dose escalation scheme. The dose for the Phase II part of the trial will be based on the MTD established in the Phase I part of the study. Clinical and laboratory parameters will be assessed to evaluate disease response and toxicity of study therapy. Safety assessments will be performed every 3 weeks for the first 24 weeks. Efficacy assessments (radiological examination) will be performed on all patients every 8 weeks (± 7 days) for the first 24 weeks. Cardiotoxicity assessments will be performed at weeks 6 and 12. From week 24, safety, efficacy and cardiotoxicity assessments will be performed every 12 weeks and at the end of treatment (disease progression, unacceptable toxicity or patient withdraws consent).

Key Dates

Start date

Mar 31, 2011

Status verified

Oct 2015

Primary completion

Oct 31, 2014

Completion

Oct 31, 2014

Study Design

Enrollment

11 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Lapatinib (Tyverb™) and (Myocet™)

Primary Outcome Measure

Optimal dose for lapatinib plus myocet [ Time Frame: 6 months ]