The CAT Study: Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer

NCT00097344 | Terminated Phase 3

• 1 other identifier: Biomed 777-CLP-30
• Study Type: interventional
• Target: 842
• Locations: 5 countries
• Sites: 104

Brief Summary

The purpose of this study is to determine whether maximal estrogen suppression achieved via the combination of an experimental drug, atamestane, plus an FDA-approved drug, toremifene (Fareston®), is more effective than another approved drug, letrozole (Femara®), in delaying the growth of breast cancer, and whether the side effects of the combined hormonal therapy are different from the side effects of letrozole.

Conditions

Breast Neoplasms; Neoplasms, Hormone-Dependent

Keywords

Aromatase inhibitor; Atamestane; Breast neoplasms; Combined hormonal therapy; Complete estrogen blockade; Ductal breast carcinoma; Estrogen blocker; Fareston®; Femara®; First line therapy; Letrozole; Lobular breast carcinoma; Locally advanced breast cancer; Locally recurrent breast cancer; Maximal estrogen inhibition; Metastatic breast cancer; Neoplasms, Hormone-dependent; Receptor-positive; Stage IIIA breast cancer; Stage IIIB breast cancer; Stage IV breast cancer; Toremifene

Outcome Measures

Primary Outcomes (1)

• Time to progression

Secondary Outcomes (3)

• Response rate

• Safety

• Overall survival

Interventions

Atamestane DRUG

Toremifene DRUG

Letrozole DRUG

Aromatase inhibition DRUG

Estrogen receptor blocker DRUG

Hormone therapy PROCEDURE

Endocrine therapy PROCEDURE

Antiestrogen therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women age 18 years or older
• Postmenopausal women who are to receive their first hormonal treatment for locally recurrent, locally advanced, or metastatic disease, and who would be appropriate candidates for treatment with antiestrogens or aromatase inhibitors.
• Locally recurrent, locally advanced, locally metastatic disease not amenable to radiation therapy or surgery and/or distant metastatic disease.
• Pathological or histological confirmation at primary diagnosis of breast cancer or at the time of diagnosis of advanced disease.
• ECOG performance status of 0, 1 or 2 or Karnofsky performance status of 60 or higher.
• Predicted life expectancy of 12 weeks or more.
• Postmenopausal endocrine status. LH/FSH levels in the postmenopausal range in women whose menopause occurred less than 5 years ago.
• At least one tumor localization measurable in 2 dimensions.
• One diameter either at least 2 cm or at least two times the CT/MRI slice/reconstruction thickness for bone/soft tissue/visceral disease assessed by CT/MRI scan (to include spiral CT technique).
• One diameter at least 2 cm for lesions other than bone lesions assessed by conventional X-ray techniques.
• One diameter at least 1 cm for bone lesions assessed by conventional X-ray techniques.
• Estrogen receptor and/or progesterone receptor positive (by laboratory/institutional standard) at the time of primary diagnosis or determined during subsequent biopsy/surgery of metastases.
• Administration of bisphosphonates in patients with bone metastases is allowed, as long as the drug is started prior to randomization of the patient.
• Written informed consent obtained.

You may not qualify if:

• Prior hormonal therapy (including oophorectomy or treatment with LH/RH analogs) to treat locally recurrent, locally advanced, or metastatic disease.
• Prior chemotherapy to treat locally recurrent, locally advanced, or metastatic disease.
• Prior adjuvant therapy with aromatase inhibitors or antiestrogens/SERMs with last dose administered within 3 months prior to enrollment.
• Primary diagnosis of disease or progression of disease during therapy with antiestrogens (including SERMs administered for prevention of osteoporosis).
• Life-threatening disease requiring chemotherapeutic intervention.
• History of known CNS metastases, significant neurological dysfunction including active seizures, or clinical signs of other significant neurological diseases.
• Other active malignancy (except basal cell carcinoma of the skin, contralateral breast cancer, or in situ cervical cancer). Patients with previous malignancies must be without evidence of disease for at least five years.
• Renal insufficiency (serum creatinine \>2.0 mg/dL).
• Aspartate aminotransferase, alanine aminotransferase, or serum bilirubin levels more than 2.5 times upper limit of normal.
• Hemoglobin \<9 g/dL.
• Platelet count of less than 100,000 platelets per mm3.
• Total white blood cell count of less than 2,000 cells per mm3.
• Premenopausal endocrine status; pregnant or lactating females.
• Usage of an investigational drug within thirty (30) days prior to enrollment; or the planned usage of an investigational drug other than the study medication during the course of the current study.
• Contraindication to use of toremifene, atamestane, letrozole, or any of the inactive components of their formulations as stated in the investigators brochure or product package insert.

Sponsors & Collaborators

• Intarcia Therapeutics: lead

Study Sites (104)

Research Site

Mobile, Alabama, 36607, United States

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Tuscon, Arizona, 85704, United States

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Hot Springs, Arkansas, 71913, United States

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Fountain Valley, California, 92708, United States

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Greenbrae, California, 94904, United States

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Los Angeles, California, 90807, United States

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Poway, California, 92064, United States

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Greenwich, Connecticut, 06830, United States

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Jacksonville, Florida, 32209, United States

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Kissimmee, Florida, 34741, United States

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Miami, Florida, 33176, United States

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Ocala, Florida, 34474, United States

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Pembroke Pines, Florida, 33028, United States

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Tampa, Florida, 33607, United States

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Augusta, Georgia, 30901, United States

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Savannah, Georgia, 31405, United States

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Evansville, Indiana, 47713, United States

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New Albany, Indiana, 47150, United States

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Lenexa, Kansas, 66214, United States

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Louisville, Kentucky, 40207, United States

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Shreveport, Louisiana, 71105, United States

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Towson, Maryland, 21204, United States

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Detroit, Michigan, 48076, United States

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Flint, Michigan, 48532, United States

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Robbinsdale, Minnesota, 55422, United States

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St Louis, Missouri, 63128, United States

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Billings, Montana, 59101, United States

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Reno, Nevada, 89502, United States

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Cherry Hill, New Jersey, 08003, United States

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Newark, New Jersey, 07101, United States

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Fresh Meadows, New York, 11365, United States

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Valhalla, New York, 10595, United States

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Wooster, Ohio, 44691, United States

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Zanesville, Ohio, 43701, United States

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Philadelphia, Pennsylvania, 19146, United States

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West Reading, Pennsylvania, 19611, United States

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Columbia, South Carolina, 29203, United States

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Bristol, Tennessee, 37620, United States

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Memphis, Tennessee, 38120, United States

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Houston, Texas, 77024, United States

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Pasadena, Texas, 77504, United States

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Ogden, Utah, 84403, United States

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Chesapeake, Virginia, 23320, United States

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Danville, Virginia, 24541, United States

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Norfolk, Virginia, 23502, United States

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Lacey, Washington, 98503, United States

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Milwaukee, Wisconsin, 53215, United States

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Racine, Wisconsin, 53405, United States

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Rhinelander, Wisconsin, 54501, United States

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Blagoevgrad, 2700, Bulgaria

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Plovdiv, 4004, Bulgaria

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Shumen, 9700, Bulgaria

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Sofia, 1233, Bulgaria

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Sofia, 1756, Bulgaria

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Stara Zagora, 6003, Bulgaria

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Varna, 9010, Bulgaria

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Arad, 310017, Romania

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Brasov, 500366, Romania

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Bucharest, 22115, Romania

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Bucharest, 22328, Romania

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Cluj-Napoca, 400015, Romania

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Oradea, 410032, Romania

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Ploieşti, 100337, Romania

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Târgu Mureş, 540141, Romania

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Timișoara, 300223, Romania

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Arkhanglsk, 163045, Russia

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Astrakhan, 414041, Russia

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Chelyabinsk, 454087, Russia

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Engel's, 413115, Russia

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Irkutsk, 664035, Russia

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Kaliningrad, 236040, Russia

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Kaluga, 248007, Russia

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Kazan', 420012, Russia

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Krasnodar, 350040, Russia

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Moscow, 119121, Russia

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Moscow, 121356, Russia

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Omsk, 644013, Russia

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Orenburg, 460021, Russia

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Oryol, 302020, Russia

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Perm, 614066, Russia

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Pyatigorsk, 357524, Russia

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Saint Petersburg, 191104, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, 197758, Russia

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Sochi, 354057, Russia

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Syktyvkar, 167904, Russia

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Tambov, 392013, Russia

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Ufa, 450054, Russia

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Ulyanovsk, 432063, Russia

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Yaroslavl, 150054, Russia

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Chernihiv, 14029, Ukraine

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Chernivtsy, 58013, Ukraine

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Donetsk, 83092, Ukraine

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Kharkiv, 61024, Ukraine

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Kherson, 73000, Ukraine

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Khmelnitsky, 29009, Ukraine

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Luhansk, 91047, Ukraine

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Lutsk, 43018, Ukraine

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Lviv, 79031, Ukraine

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Mariupol, 87500, Ukraine

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Odesa, 65025, Ukraine

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Sumy, 40005, Ukraine

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Ternopil, 46023, Ukraine

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Vinnitsa, 21021, Ukraine

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MeSH Terms

Conditions

Breast Neoplasms; Neoplasms, Hormone-Dependent; Carcinoma, Ductal, Breast; Carcinoma, Lobular

Interventions

atamestane; Toremifene; Letrozole; Aromatase Inhibitors; Estrogen Receptor Modulators

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Tamoxifen; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs

Study Officials

• Edith Perez, MD

  Professor of Medicine, Mayo Clinic, Jacksonville, Florida

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 22, 2004
• First Posted: November 23, 2004
• Study Start: December 1, 2004
• Study Completion: August 1, 2006
• Last Updated: August 23, 2007

Record last verified: 2007-08

Locations

BU (7); RU (25); US (49); RO (9); UA (14)