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A Randomized Phase III Trial of Marimastat Versus Placebo in Patients With Metastatic Breast Cancer Who Have Responding or Stable Disease After Induction Chemotherapy

Phase 3
18 Years
Not Enrolling
Breast Cancer

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Trial Information

A Randomized Phase III Trial of Marimastat Versus Placebo in Patients With Metastatic Breast Cancer Who Have Responding or Stable Disease After Induction Chemotherapy

OBJECTIVES: I. Determine whether marimastat prolongs progression-free survival in women with
metastatic breast cancer who have responding or stable disease after receiving standard
systemic chemotherapy. II. Determine the toxic effects of marimastat compared with placebo
in patients with metastatic breast cancer who have responding or stable disease after
receiving standard systemic chemotherapy. III. Determine whether there is an association
between trough marimastat concentration and time to disease progression and toxicity.

OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are
stratified by the number of involved disease sites at study entry, prior chemotherapy for
metastases, osseous disease only at study entry, and bisphosphonate therapy at study entry,
and concurrent hormonal therapy (yes vs no). Patients are randomized into two groups.
Patients take either marimastat or placebo, one capsule orally twice a day, approximately
every 12 hours (i.e., during or after breakfast and dinner). The drug or placebo is given
until the development of progressive disease or prohibitive toxicity.

PROJECTED ACCRUAL: A total of 334 patients will be accrued for this study over 2 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the breast with
previous manifestations of progressing regional or metastatic cancer Received one prior
systemic chemotherapy regimen for the treatment of metastases, which meets all of the
following criteria: Included either doxorubicin, a taxane (i.e., paclitaxel or docetaxel),
or both 6-8 courses were given If weekly taxane therapy received, at least 12 doses were
given Recovered from all related toxic effects (except alopecia and/or neuropathy) 3-6
weeks have elapsed since last course of chemotherapy was given No more than 40 weeks have
elapsed since the first dose of chemotherapy for metastases No current or prior history of
brain metastases Responding or stable disease since the initiation of systemic
chemotherapy (i.e., no disease progression) required No prior enrollment on ECOG trials
for metastatic disease

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal Status: Not specified
Performance status: ECOG 0 or 1 Hematopoietic: Granulocyte count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no
greater 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Other:
Not pregnant or nursing Negative pregnancy test required if pre- or peri-menopausal (i.e.,
last menstrual period within one year prior to study) Pre- or peri-menopausal sexually
active women must use effective contraception No other invasive malignancy within last 5
years except curatively treated basal or squamous cell carcinoma of the skin or carcinoma
in situ of the cervix No history of rheumatoid arthritis, osteoarthritis, symptomatic
osteoarthritis requiring therapy, or other inflammatory arthritis At least 5 years since
prior invasive malignancies except: Curatively treated basal cell or squamous cell
carcinoma of the skin Carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy No prior
trastuzumab Chemotherapy: See Disease Characteristics No concurrent chemotherapy No prior
marimastat or batimastat Endocrine therapy: Prior and/or concurrent hormonal therapy for
breast cancer allowed Concurrent hormonal therapy allowed Radiotherapy: No concurrent
radiotherapy Surgery: No prior organ allograft Other: At least 4 weeks since other
investigational agents No concurrent bisphosphonate therapy unless it was initiated prior
to the study No concurrent immunosuppressive therapy Patients receiving anticoagulant
therapy must be carefully monitored

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Joseph A. Sparano, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Albert Einstein College of Medicine of Yeshiva University


United States: Food and Drug Administration

Study ID:




Start Date:

September 1997

Completion Date:

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • Breast Neoplasms



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Mayo Clinic Cancer Center Rochester, Minnesota  55905
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
Hahnemann University Hospital Philadelphia, Pennsylvania  19102-1192
CCOP - Duluth Duluth, Minnesota  55805
CCOP - Scottsdale Oncology Program Scottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
Siouxland Hematology-Oncology Sioux City, Iowa  51101-1733
CentraCare Clinic Saint Cloud, Minnesota  56303
Altru Health Systems Grand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology Program Toledo, Ohio  43623-3456
Rapid City Regional Hospital Rapid City, South Dakota  57709
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080
Morristown Memorial Hospital Morristown, New Jersey  07962-1956
St. Francis Medical Center Trenton, New Jersey  08629
CCOP - Columbus Columbus, Ohio  43206
Trinitas Hospital - Jersey Street Campus Elizabeth, New Jersey  07201
Hunterdon Regional Cancer Center Flemington, New Jersey  08822
Hackensack University Medical Center Hackensack, New Jersey  07601
Riverview Medical Center Red Bank, New Jersey  07701
Medcenter One Health System Bismarck, North Dakota  58501