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NCT04060862 · ClinicalTrials.gov registry record · Phase 1
A Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT04060862 is a Phase 1 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 20 participants.
The verdict
NCT04060862, a Phase 1 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The open-label Phase Ib portion of this study will evaluate the safety and pharmacokinetics of ipatasertib in combination with palbociclib and fulvestrant to identify a dose of ipatasertib that can be combined with palbociclib and fulvestrant in the Phase III portion. The randomized Phase III portion of this study will evaluate the efficacy, safety, and patient-reported outcome (PRO) objectives of ipatasertib + palbociclib + fulvestrant compared with placebo + palbociclib + fulvestrant in patients with HR+ HER2-, locally advanced unresectable or metastatic breast cancer who had relapsed during adjuvant endocrine therapy or progressed during the initial 12 months of first-line endocrine therapy in locally advanced unresectable or metastatic breast cancer.
Interventions
- DRUG Placebo
- DRUG Ipatasertib
- DRUG Fulvestrant
- DRUG Palbociclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-11-21 |
| Est. Completion | 2023-08-29 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04060862
The ClinicalTrials.gov registry entry for NCT04060862 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04060862 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04060862 about?
NCT04060862 is a clinical study titled "A Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer". The open-label Phase Ib portion of this study will evaluate the safety and pharmacokinetics of ipatasertib in combination with palbociclib and fulvestrant to identify a dose of ipatasertib that can be combined with palbociclib and fulvestrant in the Phase III portion. The randomized Phase III portio...
What is the current status of trial NCT04060862?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2019-11-21. Estimated completion is 2023-08-29.
What interventions are being tested in trial NCT04060862?
The interventions under investigation include: Placebo (DRUG), Ipatasertib (DRUG), Fulvestrant (DRUG), Palbociclib (DRUG).
Who is sponsoring clinical trial NCT04060862?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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