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NCT01368263 · ClinicalTrials.gov registry record · Phase 2
Goserelin and Letrozole or Anastrozole in Premenopausal Patients With Stage II-III Estrogen Receptor-Positive Breast Cancer
A Phase 2 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT01368263: Clinical Trial Phase 2 study, sponsored by Washington University School of Medicine.
NCT01368263 is a Phase 2 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01368263, a Phase 2 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
This phase II trial studies the impact of a presurgical endocrine therapy, consisting of goserelin with letrozole or anastrozole on the treatment of premenopausal patients with stage II-III estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Endocrine therapy reduces the amount of estrogen in the body. E+ breast cancer require estrogen, so lower levels of estrogen may slow or stop cell growth. Giving goserelin together with letrozole or anastrozole before surgery may enhance the effectiveness of, or eliminate the need for, chemotherapy
Primary Outcome
* In patients with Ki67 \>10% and \<= 15 pg/ml at 4 weeks. * The pCR rate for neo-adjuvant chemotherapy is defined as 100 times the number of eligible patients with no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary or sentinel lymph nodes divided by the total number of eligible patients who received neo-adjuvant chemotherapy.
Interventions
- PROCEDURE Surgery
- DRUG letrozole
- DRUG anastrozole
- DRUG goserelin acetate
- DRUG chemotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
Why NCT01368263 stopped before completion
NCT01368263 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 5 interventions - of which Surgery is the first listed.
NCT01368263 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01368263 about?
NCT01368263 is a clinical study titled "Goserelin and Letrozole or Anastrozole in Premenopausal Patients With Stage II-III Estrogen Receptor-Positive Breast Cancer". This phase II trial studies the impact of a presurgical endocrine therapy, consisting of goserelin with letrozole or anastrozole on the treatment of premenopausal patients with stage II-III estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2 (HER2)-negative breast cancer. E...
What is the current status of trial NCT01368263?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2011-09. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01368263?
The interventions under investigation include: Surgery (PROCEDURE), letrozole (DRUG), anastrozole (DRUG), goserelin acetate (DRUG), chemotherapy (DRUG).
Who is sponsoring clinical trial NCT01368263?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01368263's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 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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