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Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Inclusion Criteria:

1. Histologically confirmed pathologic stage 1c-IIIA adenocarcinoma of the breast which
has been completely resected.

2. Systemic therapy is planned according to one of the following three regimens:

- Tamoxifen (20mg) given orally once per day

- Adriamycin (60 mg/m2 IV on Day 1) plus cyclophosphamide (600mg/m2 IV on Day 1),
repeated every 21 days for four courses (to begin within 8 weeks after
definitive surgery)

- Adriamycin (60mg/m2 IV on Day 1) plus cyclophosphamide (600mg/m2 IV on Day 1),
repeated every 21 days for four courses, followed by Taxol (175mg/m2 IV on Day
85) repeated every 21 days for four courses (to begin within 8 weeks after
definitive surgery).

3. ECOG performance status 0 or 1.

4. Adequate organ function as evidenced by:

- ANC > 1500/mm3

- Platelets > 100,000/mm3

- Serum Creatine < 1.5 ULN

- Total bilirubin < 1.5 x ULN

- AST < 2 x ULN

5. Patients to receive adriamycin must have LVEF > 50% or acceptable function per the
institutional practice as assessed by MUGA.

6. Signed informed consent.

7. Women age =/> 18 years

8. Patients must have recovered from reversible adverse events of prior surgery and any
radiation therapy.

9. Women of childbearing potential must have a serum or urine pregnancy test within 72
hours prior to the start of study medication.

Exclusion Criteria:

1. Patients in whom breast cancer is present at the margin or surgical resection are not
eligible in this study. Patients suspicious for residual disease following resection
are not eligible.

2. Prior chemotherapy or immunotherapy for breast cancer.

3. Documented metastatic breast cancer.

4. Other malignancy (except carcinoma in situ of the cervix or surgically treated
non-melanoma skin cancer) within 5 years of study entry.

5. Pregnant or breastfeeding females.

6. Women of child bearing potential not employing adequate contraception.

7. History of autoimmune diseases such as systemic lupus, rheumatoid arthritis,

8. Any serious underlying medical conditions which would impair the ability ot the
patient to receive the planned treatment or which may interfere with the completion
of this trial.

9. Planned chemotherapy, hormonal therapy or biological therapy other than those
described above. Patients should not be enrolled in any other clinical trials. Use
of other investigational agents is not permitted.

10. Any condition that does not permit compliance with the protocol.

Type of Study:


Study Design:

Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms



Local Institution Chicago, Illinois  
Local Institution Indianapolis, Indiana  
Local Institution Baltimore, Maryland  
Local Institution Bronx, New York  
Local Institution Cincinnati, Ohio  
Local Institution Portland, Oregon  
Local Institution Burlington, Vermont  
Local Institution Vancouver, Washington  
Local Institution Green Bay, Wisconsin