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Evaluation of Novel Therapeutic Agents Against Breast Cancer: An Innovative Randomized Phase II Trial Design

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Evaluation of Novel Therapeutic Agents Against Breast Cancer: An Innovative Randomized Phase II Trial Design

OBJECTIVES: I. Determine the activity of interleukin-12 as defined by the percentage of
patients who have not progressed after 6 months of therapy. II. Compare percentage of
patients who have not progressed after six months with or without treatment regimen. III.
Determine time to progression and overall survival in this patient population after this

OUTLINE: This is a randomized study. Patients are stratified according to disease free
interval from primary diagnosis to first metastases (less than 3 years vs 3 years and
longer), estrogen receptor status (positive vs negative), and disease status (complete
response, partial response, detectable disease, or stable disease). Patients are randomized
to one of two treatment arms. Arm I: Patients begin therapy no sooner than 3 weeks and no
later than 6 weeks since last chemotherapy dose. Patients receive interleukin-12
subcutaneously twice a week. Treatment continues in the absence of disease progression or
unacceptable toxicity. Patients are followed at least every 3 months for 1 year. If no
progression after 1 year, may be followed as needed for new signs or symptoms and survival
for 5 years. Arm II: Patients are observed for 6 months. If disease progresses during first
6 months, patients may receive interleukin-12 as in arm I. Patients without disease
progression within first 6 months may also then receive interleukin-12 as in arm I.
Treatment continues in the absence of disease progression or unacceptable toxicity. Patients
are followed for toxicity only until interleukin-12 is discontinued.

PROJECTED ACCRUAL: A total of 92 patients (46 per arm) will be accrued for this study within
8 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic or recurrent breast cancer
(not confined to breast) One prior induction chemotherapy regimen for recurrent or
metastatic disease (4 weeks of treatment for 4-6 courses) resulting in stable disease,
partial response, or complete response Pleural or peritoneal effusion palliated by
induction chemotherapy allowed No uncontrolled brain metastases Previously treated brain
metastases allowed if: No evidence of progression for at least 3 months following
radiotherapy and/or surgical treatment AND At least 30 days since dexamethasone or other
corticosteroids AND Other metastatic site exists No bone marrow or brain as only sites of
metastases No meningeal disease Hormone receptor status Estrogen receptor status known

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Menopausal status:
Not specified Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3
Absolute neutrophil count at least 1,500/mm3 Hemoglobin at least 9 g/dL (transfusion or
epoetin alfa allowed) Platelet count at least 100,000/mm3 Hepatic: SGOT/SGPT no greater
than 1.5 times upper limit of normal (ULN) Albumin at least 3.0 g/dL Bilirubin no greater
than 1.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Creatinine clearance at
least 60 mL/min Other: No other active malignancy except nonmelanoma skin cancer Not
pregnant or nursing Fertile patients must use effective contraception No inflammatory
bowel disease or active gastric ulcer No prior autoimmune disease or immunodeficiency

PRIOR CONCURRENT THERAPY: Biologic therapy: See Chemotherapy No concurrent interleukin-11
Chemotherapy: See Disease Characteristics No concurrent chemotherapy Prior chemotherapy
with bone marrow progenitor support (bone marrow transplant and/or peripheral blood stem
cell support) allowed in adjuvant setting only (not for metastases) Endocrine therapy:
Prior hormone therapy for breast cancer allowed No concurrent hormones allowed except for
non-cancer or cancer treatment related conditions (e.g. insulin for diabetes) No
concurrent dexamethasone or other steroidal antiemetics Radiotherapy: Prior radiotherapy
allowed No concurrent radiotherapy Surgery: Not specified Other: Prior bisphosphonate
therapy allowed if started at least 3 months before study No initiation of bisphosphonate
therapy during study

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Daniel F. Hayes, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan Cancer Center


United States: Federal Government

Study ID:




Start Date:

December 1999

Completion Date:

February 2002

Related Keywords:

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



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