RecruitingPhase 2NCT06042569

Dose-Reduced Docetaxel With Cyclophosphamide for the Treatment of Vulnerable Older Women With Stage I-III HER2 Negative Breast Cancer, the DOROTHY Trial

Dose Reduction of Docetaxel-Based Chemotherapy in Vulnerable Older Women With Early-Stage Breast Cancer (DOROTHY)

Sponsor

City of Hope Medical Center

Enrollment

174 participants

Start Date

Sep 16, 2024

Study Type

INTERVENTIONAL

Conditions

HER2-Negative Breast Carcinoma Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage I Breast Cancer AJCC v8

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.

Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a lower-dose chemotherapy combination (docetaxel and cyclophosphamide) specifically designed for older or more fragile women with early-stage, HER2-negative breast cancer, to see if it is effective while causing fewer side effects than standard regimens. **You may be eligible if...** - You are 65 years old or older - You have confirmed HER2-negative breast cancer that has not spread to other organs (non-metastatic) - Your cancer stage and treatment plan has been assessed by your oncologist - You are willing to complete questionnaires during the study **You may NOT be eligible if...** - Your breast cancer is HER2-positive - Your cancer has spread to distant organs (metastatic) - You have other serious health conditions that would make this chemotherapy unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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