Know Cancer

forgot password

Phase II Evaluation of Docetaxel Combined With Estramustine Phosphate in Patients With Metastatic Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

Phase II Evaluation of Docetaxel Combined With Estramustine Phosphate in Patients With Metastatic Breast Cancer

OBJECTIVES: I. Determine the response rate, duration of response, duration of survival, and
quality of life effects of docetaxel and estramustine combination in women with metastatic
breast cancer.

OUTLINE: Patients receive estramustine 3 times a day for 3 days. Docetaxel begins on day 3
after the a.m. dose of estramustine and is given as a 1 hour infusion intravenously. Courses
repeat every 21 days. If disease responds or is stable, treatment continues at the highest
tolerance percentage of prescribed dose until appearance of disease progression. If complete
response is documented, an additional 2 courses are given. Patients should receive a minimum
of 2 courses unless rapid progression or unacceptable toxicity occur. Patients are followed

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic breast cancer Measurable or
evaluable disease Must be ineligible for other high priority national or institutional
study No visible metastases on brain CT or MRI (unless single lesion amenable to surgical
resection) Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: Over 18 Sex: Female Menopausal status: Not specified
Performance status: ECOG 0-2 Life expectancy: More than 2 months Hematopoietic: WBC
greater than 3,000/mm3 Platelet count greater than 100,000/mm3 No prior clotting disorder
unless therapeutically anticoagulated Hepatic: Bilirubin less than the upper limit of
normal SGOT or SGPT less than 1.5 times normal Renal: BUN less than 1.5 times normal
Creatinine less than 1.5 times normal Cardiovascular: No prior thromboembolism unless
therapeutically anticoagulated Other: No symptomatic ascites, pleural effusion or
peripheral edema No serious medical or psychiatric illness No prior malignancy other than
curatively treated carcinoma in situ of the cervix or skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior chemotherapy (2 weeks if weekly regimen) Any number of prior chemotherapy
regimens allowed Endocrine therapy: Any number of prior hormonal therapy regimens allowed
Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 1 week since
prior surgery

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Amy D. Tiersten, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

February 1997

Completion Date:

Related Keywords:

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



Herbert Irving Comprehensive Cancer Center New York, New York  10032