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NCT02476786 · ClinicalTrials.gov registry record · Phase 2
Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score
A Phase 2 study of Breast Cancer and Breast Neoplasms, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT02476786: Recruiting Phase 2 study of Breast Cancer and Breast Neoplasms, sponsored by Washington University School of Medicine.
NCT02476786 is a Phase 2 study of Breast Cancer and Breast Neoplasms that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 50 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02476786, a Phase 2 study of Breast Cancer and Breast Neoplasms, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Multiple neoadjuvant endocrine trials demonstrate that women with good prognosis tumors can be identified. These trials have also demonstrated that there are not adverse effects on overall outcome if women are treated with neoadjuvant endocrine therapy for several months prior to definitive treatment. A new standard of care needs to be defined for elderly women with good prognosis estrogen receptor (ER)+ tumors, since these women may benefit from endocrine therapy alone to treat their cancer without compromising local and distant control. The investigators hypothesize that endocrine therapy alone provides adequate local and systemic control of breast cancer in a subpopulation of women 70 or older with ER+ breast cancer and low Ki67 scores.
Primary Outcome
* Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) \[Eur J Ca 45:228-247, 2009\]. * In each RECIST response category Oncotype DX scores will be summarized with mean, standard deviation, minimum, 1st, 2nd (median) and 3rd quartiles, and maximum values. OncotypeDx scores range from 0 to 100, with scores \<18 indicating low risk.
Conditions Studied
Interventions
- DRUG Anastrozole
- DRUG Exemestane
- DRUG Fulvestrant
- BEHAVIORAL FACT-B
- DRUG Goserelin
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2017-01-17 |
| Est. Completion | 2032-07-31 |
| Phase | Phase 2 |
What NCT02476786 shows while recruiting
NCT02476786 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Anastrozole is the first listed.
NCT02476786 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT02476786 about?
NCT02476786 is a clinical study titled "Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score". Multiple neoadjuvant endocrine trials demonstrate that women with good prognosis tumors can be identified. These trials have also demonstrated that there are not adverse effects on overall outcome if women are treated with neoadjuvant endocrine therapy for several months prior to definitive treatmen...
What is the current status of trial NCT02476786?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2017-01-17. Estimated completion is 2032-07-31.
What conditions does trial NCT02476786 study?
This clinical trial studies the following conditions: Breast Cancer, Breast Neoplasms, Cancer of the Breast, Cancer of Breast.
What interventions are being tested in trial NCT02476786?
The interventions under investigation include: Anastrozole (DRUG), Exemestane (DRUG), Fulvestrant (DRUG), FACT-B (BEHAVIORAL), Goserelin (DRUG).
Who is sponsoring clinical trial NCT02476786?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02476786 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02476786's enrollment target sits among peer trials
50 789th of 1224 higher than 410 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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.
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