Ignite Creation Date:
2024-05-05 @ 10:42 PM
Last Modification Date:
2024-10-26 @ 10:23 AM
Study NCT ID:
NCT01172223
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2010-07-28
Brief Title:
Primary Chemotherapy in Patients With HER2-positive Early Breast Cancer
Sponsor:
Prof Dirk Elling
Organization:
Sana-Klinikum Lichtenberg
Study Overview
Official Title:
Phase III Trial of Primary Chemotherapy With Non-pegylated Liposomal Doxorubicin Paclitaxel and Lapatinib in Patients With HER2-positive Early
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LAPADO
Brief Summary:
Open-label multicenter phase III 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 mgm2 iv day 1 q3 weeks
Paclitaxel 175 mgm2 iv day 1 q3 weeks and
Lapatinib GW572016 Tykerb 750-1500 mgd 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
Non-pegylated liposomal doxorubicin NPLD Myocet 60 mgm2 iv day 1 q3 weeks
Paclitaxel 175 mgm2 iv day 1 q3 weeks and
Lapatinib GW572016 Tykerb 750-1500 mgd 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
Detailed Description:
Breast cancer is the most common malignancy affecting females in northern Europe and North America corresponding to an age-corrected annual incidence of 100 to 120 per 100000 females Approximately 30-40 of all patients treated with curative intent will develop metastatic disease Perioperative systemic treatment has made a major impact on relapse-free and overall survival of women with early-stage breast cancer with therapeutic strategies being based on the endocrine responsiveness and the estimated risk of relapse defined by tumor size axillary lymph node involvement histologic and nuclear grade lymphatic andor vascular invasion HER2neu-overexpression and age Perioperative therapy has traditionally been administered postoperatively but chemotherapy is increasingly utilized in the preoperative setting as it can significantly improve the rate of breast conserving surgery and new regimens can be evaluated rapidly and more precisely
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2007-000924-42 | EUDRACT_NUMBER | None | None |