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NCT06042569 · ClinicalTrials.gov registry record · Phase 2
Dose-Reduced Docetaxel With Cyclophosphamide for the Treatment of Vulnerable Older Women With Stage I-III HER2 Negative Breast Cancer, the DOROTHY Trial
A Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 174
- Enrollment target
- 2
- Study locations
NCT06042569 is a Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8 that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 174 participants, below the 303-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (43% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT06042569, a Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 174 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase II trial tests how well dose-reduced docetaxel combined with cyclophosphamide works in treating older women with early stage (stage I-III) HER2 negative breast cancer vulnerable to toxicity. Chemotherapy drugs, such as docetaxel and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Docetaxel and cyclophosphamide are commonly used, but is not well tolerated at the standard dose and can affect the way older patients feel physically and emotionally. Giving dose-reduced docetaxel combined with cyclophosphamide may be an effective treatment option and improve quality of life in vulnerable older women with stage I-III HER2 negative breast cancer.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Docetaxel
- OTHER Questionnaire Administration
- OTHER Medical Chart Review
Study Locations (2)
California
- City of Hope Medical Center - Duarte
Massachusetts
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2024-09-16 |
| Est. Completion | 2030-03-20 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06042569
The ClinicalTrials.gov registry entry for NCT06042569 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 174 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 303-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (43% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Anatomic Stage III Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT06042569 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06042569 about?
NCT06042569 is a clinical study titled "Dose-Reduced Docetaxel With Cyclophosphamide for the Treatment of Vulnerable Older Women With Stage I-III HER2 Negative Breast Cancer, the DOROTHY Trial". This phase II trial tests how well dose-reduced docetaxel combined with cyclophosphamide works in treating older women with early stage (stage I-III) HER2 negative breast cancer vulnerable to toxicity. Chemotherapy drugs, such as docetaxel and cyclophosphamide, work in different ways to stop the gro...
What is the current status of trial NCT06042569?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 174 participants. The study started on 2024-09-16. Estimated completion is 2030-03-20.
What conditions does trial NCT06042569 study?
This clinical trial studies the following conditions: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, HER2-Negative Breast Carcinoma.
What interventions are being tested in trial NCT06042569?
The interventions under investigation include: Cyclophosphamide (DRUG), Docetaxel (DRUG), Questionnaire Administration (OTHER), Medical Chart Review (OTHER).
Who is sponsoring clinical trial NCT06042569?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06042569 being conducted?
This trial has 2 study locations across California, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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