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NCT01864746 · ClinicalTrials.gov registry record · Phase 3
A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery
A Phase 3 study of Breast Cancer and Hormonreceptor Positive, sponsored by GBG Forschungs.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,250
- Enrollment target
- 11
- Study locations
NCT01864746: Completed Phase 3 study of Breast Cancer and Hormonreceptor Positive, sponsored by GBG Forschungs.
NCT01864746 is a Phase 3 study of Breast Cancer and Hormonreceptor Positive that has completed, run by GBG Forschungs. The registered enrollment target is 1,250 participants, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (55% lower). The trial reports 11 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01864746, a Phase 3 study of Breast Cancer and Hormonreceptor Positive, has completed, sponsored by GBG Forschungs.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,250 participants
- Enrollment target
- 11
- Study locations
Study Summary
The PENELOPEB study is designed to demonstrate that, in the background of standard anti-hormonal therapy, palbociclib provides superior invasive disease-free survival (iDFS) compared to placebo in pre- and postmenopausal women with HR-positive/HER2-normal early breast cancer at high risk of relapse after showing less than pathological complete response to neoadjuvant taxane- containing chemotherapy. Considering the high risk of recurrence in patients after neoadjuvant chemotherapy and a high CPS-EG score, palbociclib appears to be an attractive option with a favourable safety profile for these patients.
Primary Outcome
Invasive disease-free survival (iDFS) is defined according to Hudis (J Clin Oncol 2007) as the time period between randomization and first event (ipsi- or contralateral invasive in-breast or loco-regional recurrence, distant recurrence, death from breast cancer, death from non-breast cancer cause, death from unknown cause, invasive contralateral breast cancer, second primary invasive cancer (non-breast)) assessed until the end of study.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Palbociclib PD-0332991
Study Locations (11)
Other
- Contact: Austrian Breast & Colorectal Cancer Study Group - Vienna
- Contact: NSABP Foundation - Multiple Locations
- Contact: UNICANCER - Paris
- Contact: German Breast Group - Neu-Isenburg
- Contact: Cancer Trials Ireland - Dublin
- Contact: Japan Breast Cancer Research Group - Tokyo
- Contact: Korea Cancer Study Group - Seoul
- GEICAM - San Sebastián de los Reyes
- Contact: Institute of Cancer Research - London
Pennsylvania
- NSABP Foundation - Pittsburgh
NSW 2310
- Contact: Australia and New Zealand Breast Cancer Trials Group - Newcastle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,250 participants |
| Start Date | 2013-10-30 |
| Est. Completion | 2020-12-21 |
| Phase | Phase 3 |
What the finished NCT01864746 record still lists
NCT01864746 is an interventional study that assigns participants to a tested intervention. Its 1,250 participants enrollment target places it among the larger protocols in the corpus, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (55% lower).
The record links to 5 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01864746 lists 11 locations in 3 states (Other, Pennsylvania, NSW 2310).
Frequently Asked Questions
What is clinical trial NCT01864746 about?
NCT01864746 is a clinical study titled "A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery". The PENELOPEB study is designed to demonstrate that, in the background of standard anti-hormonal therapy, palbociclib provides superior invasive disease-free survival (iDFS) compared to placebo in pre- and postmenopausal women with HR-positive/HER2-normal early breast cancer at high risk of relapse ...
What is the current status of trial NCT01864746?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,250 participants. The study started on 2013-10-30. Estimated completion is 2020-12-21.
What conditions does trial NCT01864746 study?
This clinical trial studies the following conditions: Breast Cancer, Hormonreceptor Positive, Her2-normal, Postneoadjuvant Treatment With CDK 4/6 Inhibitor, CPS-EG Score.
What interventions are being tested in trial NCT01864746?
The interventions under investigation include: Placebo (DRUG), Palbociclib PD-0332991 (DRUG).
Who is sponsoring clinical trial NCT01864746?
This trial is sponsored by GBG Forschungs, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01864746 being conducted?
This trial has 11 study locations across Pennsylvania, NSW 2310. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01864746's enrollment target sits among peer trials
1,250 98th of 1224 higher than 1,126 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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