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NCT00968968 · ClinicalTrials.gov registry record · Phase 3
Continued HER2 Suppression With Lapatinib Plus Trastuzumab Versus Trastuzumab Alone
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 37
- Enrollment target
NCT00968968 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 37 participants.
The verdict
NCT00968968, a Phase 3 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 37 participants
- Enrollment target
Study Summary
This was a randomized, open-label, multi-center Phase III study evaluating the efficacy and safety of lapatinib in combination with trastuzumab versus trastuzumab alone as continued HER2 suppression therapy in women with HER2-positive metastatic breast cancer (MBC). Eligible subjects should have completed 12 to 24 weeks of first- or second-line treatment with trastuzumab plus chemotherapy, experienced either complete disappearance of all metastatic lesions, or persistence of metastatic disease (stable disease) without unequivocal progression or the occurrence of new lesions, and been indicated to continue to receive trastuzumab alone as maintenance therapy. Eligible subjects who entered the LPT112515 study on first-line treatment should not have known history of central nervous system (CNS) metastases; subjects who entered the study on second-line treatment should not have known history of CNS metastases or have stable (asymptomatic and off steroids ≥3 months) CNS metastases. The primary objective of this study was to compare progression-free survival (PFS) in subjects with HER2-positive MBC randomized to receive treatment with lapatinib plus trastuzumab versus those randomized to receive trastuzumab alone. The secondary objectives included overall survival, clinical benefit response rate (CR, PR or SD ≥24 weeks) and the qualitative and quantitative adverse event profile of the 2 treatment arms. It was estimated that 280 subjects (140 per group) would be required to observe 193 PFS events.
Interventions
- BIOLOGICAL Trastuzumab
- DRUG Lapatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2010-01-20 |
| Est. Completion | 2018-03-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00968968
The ClinicalTrials.gov registry entry for NCT00968968 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Trastuzumab is the first listed.
NCT00968968 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00968968 about?
NCT00968968 is a clinical study titled "Continued HER2 Suppression With Lapatinib Plus Trastuzumab Versus Trastuzumab Alone". This was a randomized, open-label, multi-center Phase III study evaluating the efficacy and safety of lapatinib in combination with trastuzumab versus trastuzumab alone as continued HER2 suppression therapy in women with HER2-positive metastatic breast cancer (MBC). Eligible subjects should have com...
What is the current status of trial NCT00968968?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 37 participants. The study started on 2010-01-20. Estimated completion is 2018-03-30.
What interventions are being tested in trial NCT00968968?
The interventions under investigation include: Trastuzumab (BIOLOGICAL), Lapatinib (DRUG).
Who is sponsoring clinical trial NCT00968968?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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