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NCT00461773 · ClinicalTrials.gov registry record · Phase 2

Randomized Phase II Study of Preoperative Letrozole (Femara) in Combination With Avastin in Hormone Receptor Positive Breast Cancer

A Phase 2 study, sponsored by Yale University.

Terminated
Registry status
Phase 2
Development phase
5
Enrollment target

NCT00461773: Clinical Trial Phase 2 study, sponsored by Yale University.

NCT00461773 is a Phase 2 study that was terminated before completion, run by Yale University. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00461773, a Phase 2 study, was terminated before completion, sponsored by Yale University.

TERMINATED
Registry status
Phase 2
Development phase
5 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the objective response rate of a combination of letrozole (Femara) and bevacizumab (Avastin) given preoperatively to postmenopausal patients with hormone sensitive breast cancer.

Primary Outcome

Clinical objective tumor response with 14 weeks of Neoadjuvant Letrozole combined with Bevacizumab was assessed using the following categories: Complete Response (CR): tumor is no longer visible. Partial response (PR): ≥ 50% decrease from baseline in the product of two perpendicular diameters, no new lesions. Progressive disease (PD): ≥ 25% increase of the product of two perpendicular diameters or new lesions. Stable Disease (SD): Neither CR, PR, or PD criteria met. Clinical tumor assessment wa

Interventions

  • DRUG Bevacizumab
  • DRUG Letrozole

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2007-03
Est. Completion 2010-05
Phase Phase 2
Yale University

1,492 total trials

Why NCT00461773 stopped before completion

NCT00461773 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which Bevacizumab is the first listed.

NCT00461773 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00461773 about?

NCT00461773 is a clinical study titled "Randomized Phase II Study of Preoperative Letrozole (Femara) in Combination With Avastin in Hormone Receptor Positive Breast Cancer". The purpose of this study is to evaluate the objective response rate of a combination of letrozole (Femara) and bevacizumab (Avastin) given preoperatively to postmenopausal patients with hormone sensitive breast cancer.

What is the current status of trial NCT00461773?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2007-03. Estimated completion is 2010-05.

What interventions are being tested in trial NCT00461773?

The interventions under investigation include: Bevacizumab (DRUG), Letrozole (DRUG).

Who is sponsoring clinical trial NCT00461773?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00461773's enrollment target sits among peer trials

5 2000th of 2000 the lowest 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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Source: ClinicalTrials.gov NCT00461773, the US trial registry maintained by the National Library of Medicine. NCT00461773 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.