Primary Chemotherapy in Patients With HER2-positive Early Breast Cancer

NCT01172223 | Completed Phase 1

• 2 other identifiers: LAPADO-Study2007-000924-42
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

Open-label, multicenter phase I/II trial. Patients with HER2-positive (overexpressing or amplified), invasive breast cancer with T1c N1-2 or T2 N0-2 disease will be treated with

• Non-pegylated liposomal doxorubicin (NPLD; Myocet, 60 mg/m\^2 i.v. day 1 q3 weeks),
• Paclitaxel (175 mg/m\^2 i.v. day 1 q3 weeks), and
• Lapatinib (GW572016, Tykerb, 750-1500 mg/d orally daily until the day of the definitive surgery) Treatment is planned for 6 cycles unless there is evidence of unacceptable toxicity, disease progression or inadequate efficacy (defined as a decrease in tumor size \<25% after 4 courses measured by ultrasound or MR-mammography), or if the patient requested to be released.

Conditions

Breast Cancer

Keywords

HER2-positive; early breast cancer

Outcome Measures

Primary Outcomes (2)

• Determine the optimal doses for NPLD, paclitaxel and lapatinib (phase I)

  every 3 weeks

• Evaluate the pathological response to NPLD, paclitaxel and lapatinib (phase II)

  every 6 weeks

Study Arms (1)

LAPADO

EXPERIMENTAL

Non-pegylated liposomal doxorubicin (NPLD; Myocet, 60 mg/m2 i.v. day 1 q3 weeks), Paclitaxel (175 mg/m2 i.v. day 1 q3 weeks), and Lapatinib (GW572016, Tykerb, 750-1500 mg/d orally daily until the day of the definitive surgery)

Drug: Myocet (Non-pegylated liposomal doxorubicin (NPLD)); Drug: Paclitaxel; Drug: Lapatinib (GW572016, Tykerb)

Interventions

Myocet (Non-pegylated liposomal doxorubicin (NPLD)) DRUG

60 mg/m\^2 i.v. day 1 q3 weeks

LAPADO

Paclitaxel DRUG

175 mg/m\^2 i.v. day 1 q3 weeks

LAPADO

Lapatinib (GW572016, Tykerb) DRUG

750-1500 mg/d orally daily until the day of the definitive surgery

LAPADO

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed breast cancer
• T1c N1-2 or T2 N0-2 disease
• HER2-positive tumours with 3+ intensity on immunohistochemical staining for HER2 or amplification of the HER2 gene on fluorescence in situ hybridization (FISH)
• No prior systemic treatment regimens for breast cancer
• Adequate hematologic function (ANC 1500 cells/µl, platelet count 100000/µl, and hemoglobin 8g/dl).
• Serum creatinine concentration \< 1.5 times the upper limit of normal (ULN) and/or creatinine clearance \>60 ml/min
• Bilirubin level \< 1.5 X ULN
• Normal cardiac function with a left ventricular ejection fraction of at least 50% (as assessed by quantitative echocardiogram or MUGA scan)
• Karnofsky performance status 80%
• Age 18 years
• If the patient is of childbearing potential, she agrees to: comply with effective contraceptive measures, has been using adequate contraception since the last menses, will use adequate contraception during the study, and has a negative pregnancy test within one week of study entry
• Written informed consent prior to admission to this study

You may not qualify if:

• Male patients
• Inflammatory or bilateral breast cancer
• Evidence of distant metastases
• Previous systemic or local treatment for breast cancer (including surgery, radiotherapy, cytotoxic and endocrine treatments)
• Past or current history of other neoplasms, except for
• Curatively treated non-melanoma skin cancer
• Adequately treated in situ carcinoma of the cervix
• Other cancer curatively treated and with no evidence of disease for at least 5 years
• Significant cardiac disease, including angina pectoris, severe cardiac arrhythmia requiring medication, severe conduction abnormalities, clinically significant valvular disease, cardiomegaly, ventricular hypertrophy, poorly uncontrolled hypertension (resting diastolic blood pressure \>115 mmHg), prior myocardial infarction, CHF, or other cardiomyopathy
• Preexisting sensoric or motor polyneuropathy Grade 2 according to NCI CTC
• Serious intercurrent medical or psychiatric illness, including serious active infection
• Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study entry.
• Detained persons or prisoners
• Pregnant or nursing women

Sponsors & Collaborators

• Prof Dirk Elling: lead

Study Sites (1)

Sana Klinikum Lichtenberg

Berlin, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Doxorubicin; Paclitaxel; Lapatinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Dirk Elling

  Sana Klinikum Lichtenberg, Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 28, 2010
• First Posted: July 29, 2010
• Study Start: September 1, 2007
• Primary Completion: January 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-10

Locations

DE (1)