EUCTR2008-000528-22-IT
Active, not recruiting
Not Applicable
Phase I/II study of Lapatinib in combination with Capecitabine and Vinorelbine for the second-line treatment of patients with refractory locally recurrent or metastatic breast cancer with ErbB2 overexpression
GRUPPO ONCOLOGICO ITALIANO DI RICERCA0 sitesMarch 19, 2009
ConditionsPatients with HER2 positive metastatic or locally recurrent adenocarcinoma of the breastMedDRA version: 14.1Level: LLTClassification code 10006174Term: Breast adenocarcinoma recurrentSystem Organ Class: 100000004864MedDRA version: 14.1Level: LLTClassification code 10065348Term: Breast adenocarcinoma metastaticSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patients with HER2 positive metastatic or locally recurrent adenocarcinoma of the breast
- Sponsor
- GRUPPO ONCOLOGICO ITALIANO DI RICERCA
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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:
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
Outcomes
Primary Outcomes
Not specified
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