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NCT01035099 · ClinicalTrials.gov registry record · Phase 4

RCT of Fixed vs Titrated Letrozole in Breast Cancer Patient Undergoing IVF

A Phase 4 study, sponsored by Weill Medical College of Cornell University.

Completed
Registry status
Phase 4
Development phase
41
Enrollment target

NCT01035099: Completed Phase 4 study, sponsored by Weill Medical College of Cornell University.

NCT01035099 is a Phase 4 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 41 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01035099, a Phase 4 study, has completed, sponsored by Weill Medical College of Cornell University.

COMPLETED
Registry status
Phase 4
Development phase
41 participants
Enrollment target

Study Summary

The purpose of this study is to compare two different ways to administer Letrozole to determine their effectiveness in blocking estrogen production during ovarian stimulation in patients with breast cancer prior to chemotherapy/radiotherapy so that oocytes or embryos can be cryopreserved and patients can possibly achieve a pregnancy after the treatment of breast cancer. During standard ovulation stimulation, the estrogen levels will exceed normal levels and may reach 10 times the normal level for a 2 week period. This may not be desirable in breast cancer patients. The study hopes to determine if the investigators can stimulate oocyte development in the conventional way and administer different doses of Letrozole as the oocytes develop, to keep estradiol levels low, increase the number of oocytes the investigators are able to recover, and improve the quality of those oocytes.

Primary Outcome

Mature oocyte yield in each group

Interventions

  • DRUG Letrozole

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2009-11
Est. Completion 2022-09-30
Phase Phase 4

What the finished NCT01035099 record still lists

NCT01035099 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 1 intervention - of which Letrozole is the first listed.

NCT01035099 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01035099 about?

NCT01035099 is a clinical study titled "RCT of Fixed vs Titrated Letrozole in Breast Cancer Patient Undergoing IVF". The purpose of this study is to compare two different ways to administer Letrozole to determine their effectiveness in blocking estrogen production during ovarian stimulation in patients with breast cancer prior to chemotherapy/radiotherapy so that oocytes or embryos can be cryopreserved and patient...

What is the current status of trial NCT01035099?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 41 participants. The study started on 2009-11. Estimated completion is 2022-09-30.

What interventions are being tested in trial NCT01035099?

The interventions under investigation include: Letrozole (DRUG).

Who is sponsoring clinical trial NCT01035099?

This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01035099's enrollment target sits among peer trials

41 1390th of 2000 higher than 604 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT01035099, the US trial registry maintained by the National Library of Medicine. NCT01035099 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.