NCT06042569

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. Compare the relative dose intensity (RDI) of reduced- versus (vs.) standard-dose docetaxel dosing strategies. SECONDARY OBJECTIVE: I. Compare treatment tolerability of reduced- vs. standard-dose docetaxel dosing strategies. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive dose-reduced docetaxel intravenously (IV) over 60 minutes and cyclophosphamide IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive standard dose docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days then at least twice yearly for 2 years.

Conditions

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

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Given IV
DRUG	Docetaxel	Given IV
OTHER	Medical Chart Review	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2024-09-16
• Primary completion: 2030-03-20
• Completion: 2030-03-20
• First posted: 2023-09-18
• Last updated: 2026-04-17

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study