Dose-Dense Docetaxel Before or After Doxorubicin/Cyclophosphamide in Axillary Node-Positive Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Docetaxel; Drug: Doxorubicin; Drug: Cyclophosphamide (AC)

• Registration Number: NCT00201708
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

This study will determine if docetaxel will be administered before or after doxorubicin/cyclophosphamides in an adjuvant chemotherapy regimen to be evaluated in a subsequent phase III trial.

Detailed Description

Rationale: Studies suggest that chemotherapy agents docetaxel, doxorubicin, and cyclophosphamide have some efficacy against different types of breast cancer. However, the optimal sequence in which to administer these treatments remains unknown. The current study assesses two separate sequences of docetaxel, doxorubicin, and cyclophosphamide.

Purpose: This study will evaluate two different combination chemotherapy schedules for patients with axillary node-positive breast cancer. Combination one is docetaxel before doxorubicin and cyclophosphamide. Combination two is docetaxel after doxorubicin and cyclophosphamide. The combination with no dose reductions of docetaxel within 10 weeks will then be tested in a Phase III study. The toxicities of docetaxel will also be assessed in study participants.

Treatment: Patients in this study will receive one of two chemotherapy combination schedules. A computer will randomly assign patients into their treatment group. Group one will receive docetaxel before doxorubicin and cyclophosphamide. Group two will receive docetaxel after doxorubicin and cyclophosphamide.

Patients in group one will receive docetaxel every two weeks for a total of eight weeks. These patients will then be given combination doxorubicin and cyclophosphamide every two weeks for a total of eight weeks. Patients in group two will receive combination doxorubicin and cyclophosphamide every two weeks for a total of eight weeks. These patients will then be given docetaxel every two weeks for a total of eight weeks.

Several tests and exams will be given throughout the study to closely monitor patients. Treatments will be discontinued due to disease growth or unacceptable side effects.

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2006-12
• Study Completion: 2014-02
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-01
• Last Update Posted: 2016-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

• Must have histologically or cytologically confirmed breast cancer
• No metastatic disease
• Prior lumpectomy or mastectomy
• No prior chemotherapy or hormone treatments for breast cancer
• Must have normal organ and marrow function.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

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Exclusion Criteria

• Peripheral neuropathy of grade II or higher.
• History or evidence upon physical exam of CNS (central nervous system Diseases)disease.
• History of unstable angina or myocardial infarction within the last six months.
• Pregnant or nursing women.
• Known allergies to polysorbate 80.
• HIV-positive patients.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A (Docetaxel before doxorubicin/cyclophosphamide)	Cyclophosphamide (AC)	Docetaxel 75 mg/m2 every 2 weeks for 4 cycles followed by "A" (doxorubicin) 60 mg/m2 \& "C" (cyclophosphamide) 600 mg/m2 every 2 weeks for 4 cycles.
Arm B (Docetaxel after doxorubicin/cyclophosphamide)	Cyclophosphamide (AC)	"A" (doxorubicin) 60 mg/m2 \& "C" (cyclophosphamide) 600 mg/m2 every 2 weeks for 4 cycles followed by Docetaxel 75 mg/m2 every 2 weeks for 4 cycles.
Arm A (Docetaxel before doxorubicin/cyclophosphamide)	Docetaxel	Docetaxel 75 mg/m2 every 2 weeks for 4 cycles followed by "A" (doxorubicin) 60 mg/m2 \& "C" (cyclophosphamide) 600 mg/m2 every 2 weeks for 4 cycles.
Arm A (Docetaxel before doxorubicin/cyclophosphamide)	Doxorubicin	Docetaxel 75 mg/m2 every 2 weeks for 4 cycles followed by "A" (doxorubicin) 60 mg/m2 \& "C" (cyclophosphamide) 600 mg/m2 every 2 weeks for 4 cycles.
Arm B (Docetaxel after doxorubicin/cyclophosphamide)	Doxorubicin	"A" (doxorubicin) 60 mg/m2 \& "C" (cyclophosphamide) 600 mg/m2 every 2 weeks for 4 cycles followed by Docetaxel 75 mg/m2 every 2 weeks for 4 cycles.
Arm B (Docetaxel after doxorubicin/cyclophosphamide)	Docetaxel	"A" (doxorubicin) 60 mg/m2 \& "C" (cyclophosphamide) 600 mg/m2 every 2 weeks for 4 cycles followed by Docetaxel 75 mg/m2 every 2 weeks for 4 cycles.

Primary Outcome Measures

Name	Time	Method
Select one of two adjuvant chemotherapy regimens for evaluation in subsequent phase III trial.	up to 8 weeks	Docetaxel before doxorubicin/cyclophosphamide(AC)or Docetaxel after AC. The regimen selection will be based on the proportion of patients receiving four cycles of Docetaxel with no dose reductions within 10 weeks.

Secondary Outcome Measures

Name	Time	Method
Determine the toxicities of Docetaxel administered before or after doxorubicin/cyclophosphamide(AC).	up to 5 years

Trial Locations

Locations (1)

Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States