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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-06506 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 21374 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Rising Tide Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I: (Dose-reduced docetaxel, cyclophosphamide) | Experimental | 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. |
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| Arm II: (Standard dose docetaxel, cyclophosphamide) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | Given IV |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | At completion of 4 cycles, up to 12 weeks (each cycle is every three weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment success | Treatment success is defined as the proportion of patients who receive all 4 planned cycles of chemotherapy without unacceptable toxicity (grade 3-4), hospitalization/death at the end of treatment, and without decline in physical function status. Proportion of treatment success between the 2 arms will be compared using Chi-square test. A one-sided p-value of < 0.05 will be considered statistically significant. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thanh Nga Doan, MD | Contact | 626-321-1845 | tdoan@coh.org |
| Name | Affiliation | Role |
|---|---|---|
| Thanh Nga E Doan, MD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Recruiting | Duarte | California | 91010 | United States |
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Randomization module also conceals allocation from other study personnel except the biostatistician and the designated study coordinator by limiting their user's right.
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| Docetaxel | Drug | Given IV |
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| Medical Chart Review | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| At completion of 4 cycles, up to 12 weeks (Each cycle is three weeks) |
| Patient-reported symptomatic toxicities | Toxicities will be described using the National Cancer Institute (NCI) Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE). Patient reported outcomes will evaluate how well symptoms reported correlate/agree with clinician reported adverse events. | 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 | Treatment related toxicities grade 3 or higher experienced by patients between the 2 arms will be described using NCI-CTCAE version (v) 5.0. Chi-square or Fisher exact test will be used to explore the difference in terms of rate of PRO-CTCAE and clinician reported CTCAE between the 2 arms at the end of chemotherapy. Agreement proportions between PRO-CTCAE and clinician reported CTCAE will be explored and calculated for the 2 arms combined. | 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 | Patient-reported satisfaction will be measured using the Was It Worth It questionnaire. Data will be scored and summarized according to their scoring manual. Chi-square or Fisher exact test will be used to compare the proportion of patients who consider it worthwhile to undergo treatment, the proportion of patients who would undergo the treatment again, and the proportionof patients who would recommend the treatment to others between the 2 arms. | Up to 3 months after treatment ends |
| Changes in function and health status | Elements of the Geriatric Assessment (GA) will be used to calculate the deficit accumulation index for each patient on each study arm over time. Trajectories of change in function will be examined. Data will be scored and summarized according to the GA scoring manual. | At baseline and at 3, 6, 12 and 24 months after treatment ends |
| Incidence of adverse events | Toxicity experienced by patients for each arm at each cycle will be described using NCI CTCAE v 5.0. Hematologic and non-hematologic toxicities will be examined by grade, type and offending agent. | At every 3 weeks up to completion of study treatment |
| Invasive disease-free survival | Defined as an occurrence of ipsilateral invasive breast cancer recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer and second non-breast invasive cancer. | Up to 2 years |
| Local recurrences | Local recurrence will be defined as the number of in-breast, chest wall after mastectomy and axillary recurrences. | Up to 3 years |
| Distant recurrences | Distant recurrence will be defined as the number of recurrences occurring with or without localized recurrence that have occurred distant to the breast. | Up to 2 years |
| Overall survival | Breast cancer-specific survival and cause of death will also be examined. | From registration to death due to any cause up to 24 months |
| Progression-free survival | The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works. | From registration to the earliest of progression or death due to any cause up to 24 months |
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
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| University of Rochester | Recruiting | Rochester | New York | 14642 | United States |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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