Patients with HER2 positive metastatic or locally recurrent adenocarcinoma of the breast MedDRA version: 14.1 Level: LLT Classification code 10006174 Term: Breast adenocarcinoma recurrent System Organ Class: 100000004864 MedDRA version: 14.1 Level: LLT Classification code 10065348 Term: Breast adenocarcinoma metastatic System Organ Class: 100000004864
Conditions
Interventions
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Lapatinib
Concentration unit: mg milligram(s)
Concentration number: 250-
Trade Name: XELODA
Pharmaceutical Form: Tablet
INN or Proposed IN
Sponsors
GRUPPO ONCOLOGICO ITALIANO DI RICERCA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written informed consent (informed consent document to be approved by the Independent Ethics Committee [IEC]) obtained prior to any study-specific procedure Age >=18 years Able to comply with the protocol Histologically or cytologically confirmed, HER2-positive (IHC3+ or FISH), pre- or post-menopausal women with adenocarcinoma of the breast with measurable or evaluable LR or metastatic disease, who are candidates for second-line chemotherapy. Locally recurrent disease must not be amenable to radiation therapy or resection with curative intent Subjects must have refractory breast cancer defined as progression to first line chemotherapy which included trastuzumab in the locally advanced or metastatic setting or relapsed within 6 months of completing adjuvant therapy which included trastuzumab. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 Life expectancy of >=12 weeks Prior adjuvant or in metastatic disease endocrine therapy is allowed One prior chemotherapeutic regimen for the LR/metastatic disease including trastuzumab (Cumulative dose of previous anthracycline in the adjuvant setting superior of 540mg/mq for epirubicin and 360 mg/mq for doxorubicin (provided that patients have been off-treatment for at least one year). Prior radiation therapy is allowed if: delivered in the adjuvant setting as a part of the treatment of early breast cancer (at least 4 weeks before inclusion in the study) delivered prior to study entry for the relief of metastatic bone pain, provided that no more than 30% of marrow-bearing bone has been irradiated (if using chemotherapy backbone which is highly myelosuppressive) Adequate haematological function Adequate liver function Adequate renal function 14. Cardiac ejection fraction within the institutional range of normal (> 50%) as measured by echocardiogram or MUGA scan. Note that baseline and on treatment scans should be performed using the same modality and preferably at the same institution. Premenopausal patients should not be pregnant or breast-feeding. Women with an intact uterus (unless amenorrhoeic for the last 24 months) must have a negative serum pregnancy test within 28 days prior to inclusion into the study. If a serum pregnancy test is not performed within 7 days prior to the first dose of treatment, a confirmatory urine test (within 7 days prior to the first dose of treatment) is required. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: More than 1 line of chemotherapy for LR or mBC Concomitant hormonal therapy for LR or metastatic disease, however previous hormonal therapy is allowed for adjuvant, LR, or mBC Patients must have received no radiation therapy for the treatment of metastatic disease (apart from those who received it for the relief of metastatic bone pain and with the precautions mentioned above) Evidence of CNS metastases (even if previously treated). If suspected, the patient should be scanned within 28 days prior to enrolment to rule out CNS metastases Pre-existing peripheral neuropathy NCI CTC-AE Grade >2 at enrolment Clinically significant (i.e. active) cardiovascular disease for example CVA (≤ 6 months before enrolment), myocardial infarction (≤ 6 months before enrolment), unstable angina, congestive heart failure (CHF) NYHA Class ≥II, serious cardiac arrhythmia requiring medication during the study, which might interfere with regularity of the study treatment, or not controlled by medication Women with an intact uterus (unless amenorrhoeic for the last 24 months) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) during the study and for a period of 6 months following the last administration of treatment. Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment Known hypersensitivity to lapatinib and any of its excipients, and any of the chemotherapies Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the preliminary antitumor activity of the combination in terms of progression-free survival (PFS);Secondary Objective: To determine the objective response rate (RR) and overall survival (OS). To evaluate the safety of this regimen;Primary end point(s): To determine the preliminary antitumor activity of the combination in terms of progression-free survival (PFS) | — |
Countries
Italy
Outcome results
None listed