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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01864746
The ClinicalTrials.gov registry entry for NCT01864746 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,250 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (55% lower). The listed sponsor is GBG Forschungs, which has 1 total studies on file at ClinicalTrials.gov.
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 reports 11 study locations spanning 3 distinct geographic areas - top geographies include 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.
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