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NCT00728949 · ClinicalTrials.gov registry record · Phase 2

A Study for Safety and Effectiveness of IMC-A12 by Itself or Combined With Antiestrogens to Treat Breast Cancer

A Phase 2 study, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 2
Development phase
93
Enrollment target

NCT00728949: Completed Phase 2 study, sponsored by Eli Lilly and Company.

NCT00728949 is a Phase 2 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 93 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00728949, a Phase 2 study, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 2
Development phase
93 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether IMC-A12 offers increased progression-free survival (PFS) associated with IMC-A12 monotherapy and IMC-A12 in combination with an antiestrogen therapy in patients with hormone receptor positive advanced or metastatic breast cancer that have experienced disease progression on antiestrogen therapy.

Primary Outcome

PFS is defined as the time from the date of randomization until date of objectively determined progressive disease (PD) or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a ≥20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions unequivocal progression of non-target lesions. Participants without documentation of progression or

Interventions

  • DRUG Anastrozole
  • DRUG Letrozole
  • DRUG Exemestane
  • DRUG tamoxifen
  • BIOLOGICAL IMC-A12 (cixutumumab)

Trial Details

FieldValue
Enrollment Target 93 participants
Start Date 2008-08
Est. Completion 2015-02
Phase Phase 2
Eli Lilly and Company

1,341 total trials

What the finished NCT00728949 record still lists

NCT00728949 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (30% lower).

The record links to 0 conditions, and to 5 interventions - of which Anastrozole is the first listed.

NCT00728949 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00728949 about?

NCT00728949 is a clinical study titled "A Study for Safety and Effectiveness of IMC-A12 by Itself or Combined With Antiestrogens to Treat Breast Cancer". The purpose of this study is to determine whether IMC-A12 offers increased progression-free survival (PFS) associated with IMC-A12 monotherapy and IMC-A12 in combination with an antiestrogen therapy in patients with hormone receptor positive advanced or metastatic breast cancer that have experienced...

What is the current status of trial NCT00728949?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 93 participants. The study started on 2008-08. Estimated completion is 2015-02.

What interventions are being tested in trial NCT00728949?

The interventions under investigation include: Anastrozole (DRUG), Letrozole (DRUG), Exemestane (DRUG), tamoxifen (DRUG), IMC-A12 (cixutumumab) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00728949?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00728949's enrollment target sits among peer trials

93 766th of 2000 higher than 1,234 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 NCT00728949, the US trial registry maintained by the National Library of Medicine. NCT00728949 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.