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NCT01491737 · ClinicalTrials.gov registry record · Phase 2
A Study of Pertuzumab in Combination With Trastuzumab Plus an Aromatase Inhibitor in Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive and Hormone Receptor-Positive Advanced Breast Cancer
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 258
- Enrollment target
NCT01491737 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 258 participants.
The verdict
NCT01491737, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 258 participants
- Enrollment target
Study Summary
This randomized, open-label, two-arm, multi-center, Phase II study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab plus an aromatase inhibitor (AI) in first-line participants with HER2-positive and hormone receptor-positive advanced breast cancer. Participants will be randomized to one of two treatment arms; Arm A (pertuzumab in combination with trastuzumab plus an AI) or Arm B (trastuzumab plus an AI). Participants may also receive induction chemotherapy (a taxane, either docetaxel or paclitaxel) at the investigator's discretion in combination with the assigned treatment arm. The anticipated time on study treatment is until disease progression, unacceptable toxicity, withdrawal of consent, or death whichever occurs first.
Interventions
- DRUG Trastuzumab
- DRUG Pertuzumab
- DRUG Aromatase Inhibitor
- DRUG Induction Chemotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 258 participants |
| Start Date | 2012-02-17 |
| Est. Completion | 2019-11-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01491737
The ClinicalTrials.gov registry entry for NCT01491737 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 258 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 Trastuzumab is the first listed.
NCT01491737 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01491737 about?
NCT01491737 is a clinical study titled "A Study of Pertuzumab in Combination With Trastuzumab Plus an Aromatase Inhibitor in Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive and Hormone Receptor-Positive Advanced Breast Cancer". This randomized, open-label, two-arm, multi-center, Phase II study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab plus an aromatase inhibitor (AI) in first-line participants with HER2-positive and hormone receptor-positive advanced breast cancer. Participants wil...
What is the current status of trial NCT01491737?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 258 participants. The study started on 2012-02-17. Estimated completion is 2019-11-14.
What interventions are being tested in trial NCT01491737?
The interventions under investigation include: Trastuzumab (DRUG), Pertuzumab (DRUG), Aromatase Inhibitor (DRUG), Induction Chemotherapy (DRUG).
Who is sponsoring clinical trial NCT01491737?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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