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NCT00429403 · ClinicalTrials.gov registry record · Phase 3
Goserelin Acetate Study for Ovarian Function in Patients With Primary Breast Cancer
A Phase 3 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1
- Enrollment target
NCT00429403: Clinical Trial Phase 3 study, sponsored by M.D. Anderson Cancer Center.
NCT00429403 is a Phase 3 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 1 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00429403, a Phase 3 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1 participants
- Enrollment target
Study Summary
Primary Objective: * To determine the effectiveness of goserelin acetate (Zoladex) in preserving ovarian function in premenopausal women undergoing neoadjuvant and/or adjuvant chemotherapy for primary invasive breast cancer by documenting persistence or resumption of regular menses. Secondary Objectives: * To determine the incidence of pregnancy and the effect for participants' quality of life (QOL) after chemotherapy. * To determine the overall survival and disease-free survival times of study participants.
Primary Outcome
Outcome characterized in terms of two variables, each measured repeatedly over time: Follicle-stimulating hormone (FSH) level and whether vaginal bleeding occurs, each to be measured from the end of chemotherapy. For treatment comparison, "response" defined as a composite event: both \[FSH \< 15\] and vaginal bleeding observed within 12 months after the end of chemotherapy, with both FSH and vaginal bleeding baseline observed before start of chemotherapy.
Interventions
- DRUG Goserelin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2006-08 |
| Est. Completion | 2010-07 |
| Phase | Phase 3 |
Why NCT00429403 stopped before completion
NCT00429403 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Goserelin is the first listed.
NCT00429403 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00429403 about?
NCT00429403 is a clinical study titled "Goserelin Acetate Study for Ovarian Function in Patients With Primary Breast Cancer". Primary Objective: * To determine the effectiveness of goserelin acetate (Zoladex) in preserving ovarian function in premenopausal women undergoing neoadjuvant and/or adjuvant chemotherapy for primary invasive breast cancer by documenting persistence or resumption of regular menses. Secondary Obje...
What is the current status of trial NCT00429403?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1 participants. The study started on 2006-08. Estimated completion is 2010-07.
What interventions are being tested in trial NCT00429403?
The interventions under investigation include: Goserelin (DRUG).
Who is sponsoring clinical trial NCT00429403?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00429403's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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
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