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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)

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

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)

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.

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.

PROJECTED ACCRUAL: Approximately 89 patients will be accrued to this study within 14 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven metastatic (stage IV) or locally advanced
(stage IIIB) adenocarcinoma of the breast. Bidimensionally measurable disease. No active
central nervous system (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.

PATIENT CHARACTERISTICS: Age: 18 and over. Sex: Female. Menopausal status: Not specified.
Performance status: Eastern Cooperative Oncology Group (ECOG) score range 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: serum glutamic oxaloacetic
transaminase (SGOT) and/or serum glutamic pyruvic transaminase (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:left
ventricular ejection fraction (LVEF) at least institutional lower limit of normal on
multiple gated acquisition scan (MUGA) 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.

PRIOR CONCURRENT THERAPY: 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Best over-all tumor response that occurs during 6 cycles of chemotherapy

Outcome Time Frame:

18 weeks

Safety Issue:


Principal Investigator

Norman Wolmark, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NSABP Foundation, Inc.


United States: Federal Government

Study ID:




Start Date:

June 1998

Completion Date:

December 2002

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • stage IIIB breast cancer
  • Breast Neoplasms



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