ICI 182780 in Treating Women With Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

Phase II Trial Of Fulvestrant (Faslodex) In Women With Metastatic Breast Cancer And Failure on Aromatase Inhibitor Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00012025
• Other study ID #: NCCTG-N0032
• Secondary ID: CDR0000068473
• Status: Completed
• Phase: Phase 2
• First received: March 3, 2001
• Last updated: July 1, 2016
• Start date: May 2001
• Est. completion date: August 2008

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2008
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• fulvestrant

Locations

Country	Name	City	State
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	Medcenter One Health System	Bismarck	North Dakota
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	CCOP - Geisinger Clinic and Medical Center	Danville	Pennsylvania
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	CCOP - Duluth	Duluth	Minnesota
United States	CCOP - Merit Care Hospital	Fargo	North Dakota
United States	Altru Cancer Center	Grand Forks	North Dakota
United States	CCOP - St. Vincent Hospital Cancer Center, Green Bay	Green Bay	Wisconsin
United States	Mayo Clinic	Jacksonville	Florida
United States	MBCCOP - Gulf Coast	Mobile	Alabama
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	CCOP - Mayo Clinic Scottsdale Oncology Program	Scottsdale	Arizona
United States	Siouxland Hematology-Oncology	Sioux City	Iowa
United States	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	CCOP - Toledo Community Hospital	Toledo	Ohio
United States	Carle Foundation Hospital - Carle Cancer Center	Urbana	Illinois
United States	CCOP - Wichita	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

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 8

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate		Up to 10 years	No
Secondary	overall survival		Up to 10 years	No
Secondary	time to disease progression		Up to 10 years	No