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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: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT01491737 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 258 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Progression-free survival (PFS) was defined as the time from randomization until the first radiographically documented progression of disease or death from any cause, whichever occurred first (either during study treatment or during follow-up). Progression of disease was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 and is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (th
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 |
What the finished NCT01491737 record still lists
NCT01491737 is an interventional study that assigns participants to a tested intervention. The registered 258 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% higher).
The record links to 0 conditions, and to 4 interventions - of which Trastuzumab is the first listed.
NCT01491737 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01491737's enrollment target sits among peer trials
258 212th of 2000 higher than 1,787 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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