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 Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI 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.

Smith 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		Ph: 330-363-6281 Email: tmamounas@aultman.com

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
Date Submitted to PDQ		1998-05-27
Information Last Verified		2006-12-28

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