A Phase II, Randomized, Open-label Study of Lapatinib Plus Chemotherapy versus Trastuzumab Plus Chemotherapy as Firstline Treatment for Women with HER2-positive and p95HER2-positive Metastatic Breast Cancer - n/a
- Conditions
- Breast Cancer (HER2-positive and p95HER2-positive metastaticbreast cancer)MedDRA version: 14.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2010-019390-15-IE
- Lead Sponsor
- GlaxoSmithKline Research & Development Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 300
1. Female =18 years of age
2. Histologically or cytologically confirmed invasive breast cancer with distant metastasis(ses) (designated as Stage IV or metastatic breast cancer)
• Diagnosis with Stage IV or metastatic disease at either primary diagnosis or
recurrence
3. Not received prior systemic or local treatment (e.g., chemotherapy, endocrine or
radiotherapy) for Stage IV/metastatic breast cancer
• Prior adjuvant and/or neo-adjuvant therapy is permitted
4. Documentation of HER2 overexpression or gene amplification, in the invasive
component of either a metastatic disease site or primary tumor, defined as:
• 3+ by IHC
and/or
• HER2/neu gene amplification by fluorescence, chromogenic or silver in
situ hybridization [FISH, CISH or SISH; >6 HER2/neu gene copies per
nucleus or a FISH, CISH or SISH test
5. Documentation by the central laboratory of positive p95HER2 expression in the
invasive component of either a metastatic disease site (preferred) or primary tumor
6. No history of CNS metastases (including leptomeningeal involvement) or stable
CNS metastases (defined as asymptomatic and off steroids for =3 months)
7. Baseline Left Ventricular Ejection Fraction (LVEF) =50% measured by
echocardiography (ECHO) or multi-gated acquisition scan (MUGA)
8. Recovered or stabilized from all adverse events associated with prior anti-cancer
therapies, including radiotherapy, at the time of screening
9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
10. Have adequate marrow and organ function as defined in protocol
11. Women of childbearing potential, including women whose last menstrual period was <12 months ago (unless surgically sterile) must have a negative serum pregnancy test and agree to use effective contraception, as defined in Section 7.4 of protocol.
12. Signed Informed Consent Form
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
History of other malignancy.
Exception: Subjects who have been disease-free for 5 years or subjects with a history of completely resected non-melanoma skin cancer (basal or squamous) are eligible
2. Concurrent anti-cancer treatment or concurrent treatment with an investigational
drug
3. Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study treatment
4. Prior treatment with anti-HER2 therapy, except trastuzumab or lapatinib (time from
last dose of trastuzumab or lapatinib to randomization must be =3 months)
5. Serious cardiac illness or medical condition including but not confined to:
• Uncontrolled arrhythmias
• Uncontrolled or symptomatic angina
• History of congestive heart failure (CHF)
• Documented myocardial infarction <6 months from study entry
6. Current active hepatic or biliary disease (with exception of Gilbert's syndrome,
asymptomatic gallstones, liver metastases or stable chronic liver disease per
investigator assessment)
7. Concurrent disease or condition, or any pre-existing medical disorder that in the
opinion of the investigator may interfere with the subject’s safety, obtaining
informed consent or compliance to the study procedures
8. Pregnant or lactating female
9. Any clinically significant gastrointestinal abnormalities that may alter absorption
such as malabsorption syndrome or major resection of the stomach or bowels
(consult with GSK Medical Monitor if uncertain about eligibility)
10. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
chemically related to any of the study drugs or their excipients (Refer to Section 5.1. of protocol)
that, in the opinion of the investigator contra-indicates participation
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