Actively Recruiting
Dose-Reduced Docetaxel With Cyclophosphamide for the Treatment of Vulnerable Older Women With Stage I-III HER2 Negative Breast Cancer, the DOROTHY Trial
Led by City of Hope Medical Center · Updated on 2026-04-17
174
Participants Needed
3
Research Sites
287 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Dose-Reduced Docetaxel With Cyclophosphamide for the Treatment of Vulnerable Older Women With Stage I-III HER2 Negative Breast Cancer, the DOROTHY Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to provide informed consent or have a legally authorized representative consent on your behalf
- Willingness to answer questionnaires during the study
- Age 65 years or older at time of registration
- Histologically or cytologically confirmed HER2-negative breast cancer according to 2018 ASCO CAP guidelines
- Known estrogen receptor and progesterone receptor status (any ER/PR status eligible)
- Non-metastatic, invasive breast cancer (staging scans at provider discretion)
- Recommended for standard dose neoadjuvant or adjuvant docetaxel and cyclophosphamide chemotherapy by treating provider
- May receive immunotherapy concurrently if physician agrees
- Surgery, nodal assessment, radiation, and hormonal therapy may be done but not during study treatment
- Pre-operative hormonal therapy allowed if held during chemotherapy
- For bilateral or multifocal breast cancers, both must be HER2 negative and treatment recommended for at least one cancer
- Patients who do not speak or read English eligible if interpreter or translated surveys available
You will not qualify if you...
- Prior chemotherapy for current breast cancer
- Presence of recurrent or metastatic disease
- History of allergic reactions to drugs similar to cyclophosphamide or docetaxel
- Previous treatment with docetaxel and cyclophosphamide regimen for prior breast cancer
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
Research Team
T
Thanh Nga Doan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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