Clinical trial NCT00012025: ICI 182780 in Treating Women With Metastatic Breast Cancer
Official title: Phase II Trial Of Fulvestrant (Faslodex) In Women With Metastatic Breast Cancer And Failure on Aromatase Inhibitor Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: stage IV breast cancer
recurrent breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using ICI 182780 may fight breast cancer by blocking the activity of estrogen in the tumor cells.

PURPOSE: Phase II trial to study the effectiveness of ICI 182780 in treating patients who have metastatic breast cancer that has not responded to previous hormone therapy.

Detailed description: OBJECTIVES:

* Determine the complete and partial objective response rate and duration of response in women with metastatic breast cancer who have failed aromatase inhibitor therapy treated with fulvestrant.
* Determine the time to disease progression and overall survival of women treated with this drug.
* Determine the toxicity of this drug in these women.

OUTLINE: Patients receive fulvestrant intramuscularly on day 1. Courses repeat approximately every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 5 years or until disease progression. After disease progression, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed adenocarcinoma of the breast

  * Progressive local-regional or metastatic disease
  * Unconfirmed new or progressive multiple pulmonary nodules or unequivocal radiographic evidence of multiple bone metastases allowed
* At least 1 measurable lesion

  * At least 20 mm by CT scan or MRI OR at least 10 mm by spiral CT scan
  * Nonmeasurable disease includes the following:

    * Bone lesions
    * Leptomeningeal disease
    * Ascites
    * Pleural/pericardial effusions
    * Lymphangitis cutis/pulmonis
    * Inflammatory breast disease
    * Abdominal masses not confirmed and followed by imaging techniques
    * Cystic lesions
* Disease progression after prior third-generation aromatase inhibitor (e.g., anastrozole, exemestane, letrozole, or vorozole)

  * Failed no more than 1 prior additive hormonal therapy (e.g., aromatase inhibitor with or without tamoxifen)

    * Disease recurrence identified no more than 12 months since the last prior adjuvant tamoxifen treatment
    * Oophorectomy, ovarian radiotherapy, and luteinizing hormone-releasing hormone (LH-RH) analogs not considered hormonal therapy regimens
* No brain or leptomeningeal metastases
* No hepatic metastases involving more than one-third of the liver
* No symptomatic pulmonary lymphangitic disease
* Evidence of hormone sensitivity as defined by:

  * Relapse after at least 12 months of adjuvant hormonal treatment
  * Tumor remission or stabilization before progression for at least 6 months after prior hormonal therapy for advanced disease
* Postmenopausal as defined by one of the following:

  * At least 12 months since last menstrual period
  * 4-11 months since last menstrual period and follicle-stimulating hormone (FSH) in the postmenopausal range
  * Prior castration and castrate FSH levels within the postmenopausal range
  * Hysterectomy without oophorectomy (FSH in postmenopausal range if age 60 and under)
* Hormone receptor status:

  * Estrogen-receptor and/or progesterone-receptor positive

    * At least 10 fmol/mg cytosol protein OR
    * Positive by immunohistochemistry

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Sex:

* Female

Menopausal status:

* See Disease Characteristics
* Postmenopausal

Performance status:

* ECOG 0-2

Life expectancy:

* At least 3 months

Hematopoietic:

* WBC at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
* No history of bleeding diathesis

Hepatic:

* See Disease Characteristics
* Bilirubin no greater than 0.8 mg/dL above upper limit of normal (ULN)
* INR no greater than 1.6
* No hepatitis B or C
* No severe hepatic impairment

Renal:

* Calcium no greater than 10% above ULN
* Creatinine no greater than 1 mg/dL above ULN
* No severe renal impairment

Cardiovascular:

* No unstable or uncompensated cardiac condition

Pulmonary:

* No unstable or uncompensated respiratory condition

Other:

* HIV negative
* No AIDS
* No other severe condition or systemic disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Prior trastuzumab (Herceptin) allowed

Chemotherapy:

* Prior adjuvant chemotherapy allowed
* No more than 1 prior chemotherapy regimen for metastatic disease

Endocrine therapy:

* See Disease Characteristics
* More than 4 weeks since prior estrogen replacement therapy
* More than 3 months since prior LH-RH analogs
* No other prior additive hormonal therapy except third-generation aromatase inhibitors or tamoxifen

Radiotherapy:

* See Disease Characteristics
* Concurrent radiotherapy for control of bone pain or other reasons due to established bone lesions allowed if radiotherapy field is no more than 30% of bone marrow

Surgery:

* See Disease Characteristics

Other:

* More than 4 weeks since prior investigational drug for breast cancer
* No concurrent long-term warfarin
* Concurrent bisphosphonates allowed if dose stable
* Concurrent long-term antiplatelet therapy allowed

Primary outcomes:
measure: objective response rate
timeFrame: Up to 10 years
Secondary outcomes:
measure: overall survival
timeFrame: Up to 10 years
measure: time to disease progression
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Mobile
country: United States
facility: MBCCOP - Gulf Coast
state: Alabama
city: Scottsdale
country: United States
facility: CCOP - Mayo Clinic Scottsdale Oncology Program
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Peoria
country: United States
facility: CCOP - Illinois Oncology Research Association
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital - Carle Cancer Center
state: Illinois
city: Cedar Rapids
country: United States
facility: CCOP - Cedar Rapids Oncology Project
state: Iowa
city: Des Moines
country: United States
facility: CCOP - Iowa Oncology Research Association
state: Iowa
city: Sioux City
country: United States
facility: Siouxland Hematology-Oncology
state: Iowa
city: Wichita
country: United States
facility: CCOP - Wichita
state: Kansas
city: Ann Arbor
country: United States
facility: CCOP - Michigan Cancer Research Consortium
state: Michigan
city: Duluth
country: United States
facility: CCOP - Duluth
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Saint Louis Park
country: United States
facility: CCOP - Metro-Minnesota
state: Minnesota
city: Omaha
country: United States
facility: CCOP - Missouri Valley Cancer Consortium
state: Nebraska
city: Bismarck
country: United States
facility: Medcenter One Health System
state: North Dakota
city: Fargo
country: United States
facility: CCOP - Merit Care Hospital
state: North Dakota
city: Grand Forks
country: United States
facility: Altru Cancer Center
state: North Dakota
city: Toledo
country: United States
facility: CCOP - Toledo Community Hospital
state: Ohio
city: Danville
country: United States
facility: CCOP - Geisinger Clinic and Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Spartanburg
country: United States
facility: CCOP - Upstate Carolina
state: South Carolina
city: Rapid City
country: United States
facility: Rapid City Regional Hospital
state: South Dakota
city: Sioux Falls
country: United States
facility: CCOP - Sioux Community Cancer Consortium
state: South Dakota
city: Green Bay
country: United States
facility: CCOP - St. Vincent Hospital Cancer Center, Green Bay
state: Wisconsin
city: Regina
country: Canada
facility: Allan Blair Cancer Centre
state: Saskatchewan
Study officials:
affiliation: Mayo Clinic
name: James N. Ingle, MD
role: STUDY_CHAIR
References:
citation: Ingle JN, Suman VJ, Rowland KM, Mirchandani D, Bernath AM, Camoriano JK, Fishkin PA, Nikcevich DA, Perez EA; North Central Cancer Treatment Group Trial N0032. Fulvestrant in women with advanced breast cancer after progression on prior aromatase inhibitor therapy: North Central Cancer Treatment Group Trial N0032. J Clin Oncol. 2006 Mar 1;24(7):1052-6. doi: 10.1200/JCO.2005.04.1053.
citation: Ingle JN, Rowland KM, Suman VJ, et al.: Evaluation of fulvestrant in women with advanced breast cancer and progression on prior aromatase inhibitor therapy: a phase II trial of the North Central Cancer Treatment Group. [Abstract] Breast Cancer Res Treat 88 (1): A-409, 2004.