Phase II Study of Doxorubicin, Docetaxel, and Cyclophosphamide (ATC) in Women with Metastatic or Locally Advanced Breast Cancer (Summary Last Modified 04/2000)
Last Modified: 12/28/2006 First Published: 8/1/1998
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information
Alternate Title
Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase II | Treatment | Completed | 18 and over | NSABP-BP-58
NCT00003352 |
Objectives
I. Determine the overall response rate to doxorubicin, docetaxel, and
cyclophosphamide (ATC) in women with metastatic or locally advanced breast
cancer.
II. Determine survival, time to first response, time to progression, and
duration of response in these patients.
III. Evaluate the feasibility of administering ATC for at least 4 courses.
IV. Evaluate the toxicity profile of ATC and its effect on cardiac function.
Entry Criteria Disease Characteristics:
Histologically proven metastatic (stage IV) or locally advanced (stage IIIB)
adenocarcinoma of the breast
Bidimensionally measurable disease
No active CNS metastases
Brain metastases must be controlled for at least 3 months and have other sites
of measurable disease
No carcinomatous meningitis
No lymphangitic lung metastases as the only site of metastatic disease
Hormone receptor status:
Any estrogen or progesterone receptor status
Prior/Concurrent Therapy:
Biologic therapy:
Not specified
Chemotherapy:
No prior chemotherapy for metastatic breast cancer or non-breast cancer
At least 12 months since nontaxane containing adjuvant chemotherapy for
primary tumor (in patients with metastatic disease)
Prior adjuvant chemotherapy with anthracycline containing regimens allowed
(provided total doxorubicin dose did not exceed 240 mg/m2)
Endocrine therapy:
At least 4 weeks since adjuvant hormone or hormone therapy for metastatic
disease (at least 2 weeks for rapidly progressive disease)
No concurrent hormonal birth control
Radiotherapy:
At least 4 weeks since prior radiotherapy
Prior breast radiotherapy following lumpectomy allowed
No radiotherapy to greater than 30% of bone marrow
No prior left chest wall radiotherapy with anthracycline containing adjuvant
chemotherapy
Surgery:
Not specified
Patient Characteristics:
Age:
18 and over
Sex:
Female
Menopausal status:
Not specified
Performance status:
ECOG 0-2
Life expectancy:
At least 6 months
Hematopoietic:
Absolute neutrophil count at least 2,000/mm3
Platelet count at least 100,000/mm3
Hepatic:
SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN)
Alkaline phosphatase no greater than 5 times ULN
Bilirubin no greater than ULN
No SGOT and/or SGPT greater than 1.5 times ULN if concomitant with alkaline
phosphatase greater than 2.5 times ULN
Renal:
Calcium no greater than 1.2 times ULN
Creatinine no greater than 1.5 times ULN
Cardiovascular:
LVEF at least institutional lower limit of normal on MUGA scan or
echocardiogram
No myocardial infarction within 6 months
No angina pectoris requiring antianginal medication
No history of congestive heart failure
No cardiac arrhythmias requiring medication
No vascular disease with documented cardiac function compromise
No uncontrolled hypertension (diastolic greater than 100 mm Hg)
Other:
Not pregnant or nursing
Fertile patients must use effective barrier contraception
No diabetics with fasting blood sugar greater than 200 mg/dL
No peripheral neuropathy greater than grade 1
No psychosis or addictive disorders
No known hypersensitivity to E. coli-derived drugs
Expected Enrollment
Approximately 89 patients will be accrued to this study within 14 months. Outline
Patients receive intravenous doxorubicin over 15 minutes on day 0, followed by
intravenous cyclophosphamide over 30 minutes. An hour after the end of the
doxorubicin infusion, intravenous docetaxel is administered over 1 hour.
Patients receive courses every 21 days until disease progression or
unacceptable toxic effects are observed. When the maximum dose of doxorubicin
is reached, treatment continues with docetaxel and cyclophosphamide.
Patients with locally advanced breast cancer receive chemotherapy for at least
2 courses after documented response.
Patients are followed every 6 weeks.
Published ResultsSmith RE, Anderson SJ, Brown A, et al.: Phase II trial of doxorubicin/docetaxel/cyclophosphamide for locally advanced and metastatic breast cancer: results from NSABP trial BP-58. Clin Breast Cancer 3 (5): 333-40, 2002.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations National Surgical Adjuvant Breast and Bowel Project  | | | | Terry Mamounas, MD, MPH, FACS, Protocol chair | | | |
| Registry Information | | | Official Title | | A Phase II Study in Patients With Metastatic or Locally Advanced Breast Cancer to Evaluate the Worth of the Combination of Adriamycin (Doxorubicin), Taxotere (Docetaxel), and Cyclophosphamide (ATC) | | | Trial Start Date | | 1998-06-01 | | | Registered in ClinicalTrials.gov | | NCT00003352 1 | | | Date Submitted to PDQ | | 1998-05-27 | | | Information Last Verified | | 2006-12-28 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
Table of Links
| 1 | http://clinicaltrials.gov/ct/show/NCT00003352 |
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