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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT06042569
Phase
PHASE2
Status
Recruiting
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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

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Given IV
  • Docetaxel — DRUG
    Given IV
  • Medical Chart Review — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Sep 16, 2024
Status verified
Apr 2026
Primary completion
Mar 20, 2030
Completion
Mar 20, 2030

Study Design

Enrollment
174 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I: (Dose-reduced docetaxel, cyclophosphamide)
    Patients receive dose-reduced 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.
  • Active Comparator: Arm II: (Standard dose docetaxel, cyclophosphamide)
    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.

Primary Outcome Measure

Relative dose intensity (RDI) [ Time Frame: At completion of 4 cycles, up to 12 weeks (each cycle is every three weeks) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Thanh Nga Doan
[email protected]
626-256-4673
Thanh Nga Doan (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Rachel Freedman, MD
[email protected]
617-632-3000
Rachel Freedman, MD (PRINCIPAL_INVESTIGATOR)
University of RochesterRochesterNew York14642
Allison Magnuson, MD
[email protected]
585-602-5085
MD
Allison Magnuson (PRINCIPAL_INVESTIGATOR)

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By research site
City of Hope Medical Center· Duarte, CADana-Farber Cancer Institute· Boston, MAUniversity of Rochester· Rochester, NY

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