Chemotherapy Followed by Surgery in Treating Women With Stage II or Stage III Breast Cancer

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of doxorubicin and docetaxel followed by surgery in treating women who have stage II or stage III breast cancer.

Key facts

Study ID

NCT00003953

Run by

Case Comprehensive Cancer Center

People needed

39

Starts

1999-02-01

Expected to finish

2013-01-01

Last updated by the study team

2013-01-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• Patients with a prior history of malignancy other than those mentioned in section 3.1.12 are ineligible.
• Patients must not have severe concurrent medical or psychiatric illness (i.e. no severe diabetes mellitus, poorly controlled ischemic heart disease or congestive heart failure, or severe chronic obstructive or restrictive pulmonary disease).
• The interval between initial diagnosis of breast cancer and the start of treatment must not be greater than 8 weeks.
• Due to anticipated toxicities to an unborn fetus, and excretion of chemotherapy in breast milk, patients must not be pregnant or lactating and must use effective contraception during treatment.
• No history of hypersensitivity reaction to preparation containing polysorbate 80, 3.2.6 Patients must not have peripheral neuropathy grade 2 or higher.
• Patients must not have had prior radiation to >25% of bone marrow

Where it is running

• Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States
• Metro Health Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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