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Phase II Randomized Adjuvant Trial of Dose-Dense Docetaxel Before or After Doxorubicin/Cyclophosphamide (AC) in Axillary Node-Positive Breast Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Phase II Randomized Adjuvant Trial of Dose-Dense Docetaxel Before or After Doxorubicin/Cyclophosphamide (AC) in Axillary Node-Positive Breast Cancer


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.


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.

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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Select one of two adjuvant chemotherapy regimens for evaluation in subsequent phase III trial.

Outcome Description:

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.

Outcome Time Frame:

up to 8 weeks

Safety Issue:

Yes

Principal Investigator

Charles Shapiro

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Institutional Review Board

Study ID:

OSU-0450

NCT ID:

NCT00201708

Start Date:

October 2004

Completion Date:

December 2012

Related Keywords:

  • Breast Cancer
  • Adjuvant Trial
  • Dose-Dense
  • Axillary Node-Positive
  • Breast Neoplasms

Name

Location

Ohio State UniversityColumbus, Ohio  43210