Dose Reduction of Docetaxel-Based Chemotherapy in Vulnerable Older Women With Early-Stage Breast Cancer (DOROTHY)
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.
Arms & interventions
- DrugCyclophosphamide
Given IV
- DrugDocetaxel
Given IV
- OtherMedical Chart Review
Ancillary studies
- OtherQuestionnaire Administration
Ancillary studies
Outcome measures
Primary
Relative dose intensity (RDI)
RDI is defined as the ratio of actual dose intensity received to the standard dose intensity, ranging from 0 to 100%. The RDI between the two arms will be compared using T-test, RDI difference and 90% confidence interval. A one-sided p-value \< 0.05 will be considered statistically significant.
Time frame: At completion of 4 cycles, up to 12 weeks (each cycle is every three weeks)
Secondary
Treatment success
Time frame: At completion of 4 cycles, up to 12 weeks (Each cycle is three weeks)
Patient-reported symptomatic toxicities
Time frame: At each chemotherapy cycle for 4 cycles, end of treatment and at 3, 6, 12 and 24 months after treatment ends)(Each cycle is three weeks).
Differences in PRO-CTCAE and clinician-reported toxicities
Time frame: At each chemotherapy cycle for 4 cycles and at 3, 6, 12, and 24 months after treatment ends (Each cycle is three weeks).
Patient satisfaction
Time frame: Up to 3 months after treatment ends
Changes in function and health status
Time frame: At baseline and at 3, 6, 12 and 24 months after treatment ends
Incidence of adverse events
Time frame: At every 3 weeks up to completion of study treatment
Invasive disease-free survival
Time frame: Up to 2 years
Local recurrences
Time frame: Up to 3 years
Distant recurrences
Time frame: Up to 2 years
Overall survival
Time frame: From registration to death due to any cause up to 24 months
Progression-free survival
Time frame: From registration to the earliest of progression or death due to any cause up to 24 months
Eligibility criteria
Study locations (3)
City of Hope Medical Center
Duarte, California, 91010
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University of Rochester
Rochester, New York, 14642