Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01663727 · ClinicalTrials.gov registry record · Phase 3
Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 481
- Enrollment target
NCT01663727: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT01663727 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 481 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01663727, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 481 participants
- Enrollment target
Study Summary
This is a Phase III, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of bevacizumab administered in combination with paclitaxel in patients with previously untreated, locally recurrent, or metastatic HER2-negative breast cancer. Patients will be randomized to one of two treatment arms: bevacizumab or placebo. All patients will be given an intravenous (IV) infusion of of paclitaxel (90 mg/m2) for 3 weeks during each 28-day cycle. bevacizumab or placebo (10 mg/kg) will be administered by IV infusion on Days 1 and 15 of each 28-day cycle. Patients will be treated until disease progression, unacceptable toxicity or death from any cause occurs.
Primary Outcome
Tumor assessment was performed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator. Disease progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), unequivocal progression of existing non-target lesions, or presence of new lesions.
Interventions
- DRUG Placebo
- DRUG Paclitaxel
- DRUG Bevacizumab [Avastin]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 481 participants |
| Start Date | 2012-08-27 |
| Est. Completion | 2017-11-21 |
| Phase | Phase 3 |
What the finished NCT01663727 record still lists
NCT01663727 is an interventional study that assigns participants to a tested intervention. The registered 481 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01663727 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01663727 about?
NCT01663727 is a clinical study titled "Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer". This is a Phase III, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of bevacizumab administered in combination with paclitaxel in patients with previously untreated, locally recurrent, or metastatic HER2-negative breast cancer. Patients will be ran...
What is the current status of trial NCT01663727?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 481 participants. The study started on 2012-08-27. Estimated completion is 2017-11-21.
What interventions are being tested in trial NCT01663727?
The interventions under investigation include: Placebo (DRUG), Paclitaxel (DRUG), Bevacizumab [Avastin] (DRUG).
Who is sponsoring clinical trial NCT01663727?
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 NCT01663727's enrollment target sits among peer trials
481 792nd of 2000 higher than 1,209 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04449458 · 482 participants · NA
The Positively Quit Trial for Smoking Cessation
- NCT07079631 · 482 participants · Phase 1
A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment BNT327 and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal Cancer
- NCT01954992 · 480 participants · Phase 3
Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer
- NCT03023696 · 480 participants · NA
Can Prophylactic Foraminotomy Prevent C5 Palsy
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI