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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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27 July 2020 |
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Main ID: |
EUCTR2004-000015-25-GB |
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Date of registration:
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14/02/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A phase 3 randomized, placebo-controlled, double-blind study of oral CCI-779 administered in combination with letrozole vs. letrozole alone as first line hormonal therapy in postmenopausal women with locally advanced or metastatic breast cancer - HORIZON trial
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Scientific title:
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A phase 3 randomized, placebo-controlled, double-blind study of oral CCI-779 administered in combination with letrozole vs. letrozole alone as first line hormonal therapy in postmenopausal women with locally advanced or metastatic breast cancer - HORIZON trial |
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Date of first enrolment:
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15/10/2004 |
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Target sample size:
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1236 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000015-25 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: CCI-779 + Letrozole vs Placebo + Letrozole
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Latvia
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Lithuania
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Slovakia
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Women aged >=18 years.
2. Postmenopausal subjects, defined by at least one of the following:
>= 60 years of age
Physiological Menopause: < 60 years of age and amenorrheic for >=12 months prior to day 1
< 60 years of age, amenorrheic for < 12 months prior to day 1, and LH and FSH values within postmenopausal range. LH/FSH values must not be influenced by effects of medication (not chemically dependent, i.e., LHRH agonist)
Surgical Menopause: Prior bilateral oophorectomy
Prior radiation castration with amenorrhea for at least 6 months
3. Histologically and/or cytologically confirmed initial diagnosis of locally advanced (not amenable to curative surgery and/or radiation) or metastatic breast cancer (Stage 3B, 3C, or 4 respectively, by American Joint Committee on Cancer Criteria).
4. Documented estrogen receptor positive (ER+) and/or progesterone positive (PR+) tumors based on most recently analyzed biopsy.
5. At least 1 measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
6. Screening laboratory values within the following parameters:
ANC >=1.5x109/L (1500/mm3)
Platelet count >=100x109/L (100,000/mm3)[ >=80x109/L (80,000/mm3)] for subjects residing in mainland China
Hemoglobin >=8.0 g/dL (80g/L)
Serum creatinine =<1.5x upper limit of normal (ULN)
Total bilirubin =<1.5xULN
AST and ALT =<3xULN [=<5x ULN if liver metastases are present]
Fasting serum cholesterol =<350 mg/dL (9.0 mmol/L)
Fasting serum triglycerides =<400 mg/dL (4.56 mmol/L)
Serum calcium=<12.5 mg/dL (3.1 mmol/L) [value may have been obtained following initiation of treatment with bisphosphonates]
7. Karnofsky performance status (KPS) >=60 % (corresponds to Eastern Cooperative Oncology Group [ECOG] performance status 0 to 2).
8. Life expectancy of at least 6 months.
9. Ability to swallow whole tablets.
10. Signed and dated institutional review board (IRB) or independent ethics committee (IEC) approved informed consent form before any protocol-specific screening procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Extensive visceral disease including bilateral diffuse lymphangitic involvement of the lung with more than 50% lung involvement, known or suspected central nervous system (CNS) metastases, extensive hepatic involvement defined as involvement of more than one third of the liver confirmed by sonogram and/or CT scan.
2. Subjects with bone as the only site of disease.
3. History of inflammatory breast cancer (IBC).
4. Any other cancer within 5 years prior to screening with the exception of contralateral breast carcinoma, appropriately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.
5. Presence of unstable angina, recent myocardial infarction (within 6 months prior to screening), use of ongoing maintenance therapy for life-threatening ventricular arrhythmia, or known pulmonary hypertension.
6. More than 1 regimen of chemotherapy (including antibody, immunotherapy, biological, and/or cytotoxic therapy) in the locally advanced or metastatic setting. (Note: patients must have documented progression following chemotherapy in the locally advanced or metastatic setting. However, in the case of patients who receive not more than 1 cycle of the prescribed chemotherapy regimen in the locally advanced or metastatic setting, documented progression is not required). Subjects may have received prior adjuvant or neoadjuvant chemotherapy.
7. Chemotherapy or immunosuppressive agents =<2 weeks prior to day 1 of treatment on study, with the exception of systemic corticosteroids administered for physiologic replacement, or as an antiemetic after discussion with the medical monitor.
8. Hormonal treatment (including aromatase inhibitors) in the locally advanced or metastatic setting with the exception of prior short-term (< 14 days consecutive) use. Surgical menopause (e.g. oophorectomy) after diagnosis of locally advanced or metastatic disease is considered as a line of hormonal therapy.
9. Adjuvant trastuzumab (Herceptin) or tamoxifen =<2 weeks prior to day 1 of treatment on study.
10. Aromatase inhibitors as adjuvant therapy =<12 months prior to day 1 of treatment on study.
11. Disease refractory (i.e., PD within 6 months from initiation of therapy) to previous adjuvant antiestrogen therapy.
12. Major surgery, biological therapy, immunologic therapy or local radiotherapy (subjects must not have had prior cumulative radiotherapy to more than 25% of the marrow) =<2 weeks prior to day 1 of treatment on study.
13. Immunocompromised subjects, including subjects known to be human immunodeficiency virus (HIV) positive and/or acute or chronic hepatitis B (HbsAg) positive or hepatitis C virus (anti-HCV) positive.
14. Prior treatment with mTOR inhibitors.
15. Known hypersensitivity to letrozole or CCI-779.
16. Any investigational agents =< 4 weeks prior to day 1 of treatment on study
17. Any other illness that, in the investigator’s judgment, will substantially increase the risk associated with the patient’s participation in the study.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: no
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Health Condition(s) or Problem(s) studied
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locally advanced or metastatic breast cancer (stage 3B, 3C, or 4)
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Intervention(s)
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Product Name: Temsirolimus
Product Code: CCI-779 10mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Pending
CAS Number: 162635-04-3
Current Sponsor code: CCI-779
Other descriptive name: Temsirolimus, WAY-130779
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Femara (Letrozole 2.5mg )
Product Name: Femara registered trademark (Letrozole) of Ciba Laboratories
Pharmaceutical Form: Tablet
INN or Proposed INN: Letrozole
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
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Primary Outcome(s)
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Main Objective: Assessment of overall progression free survival (PFS)
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Primary end point(s): Overall progression free survival is the primary endpoint of the study, and the clinical activity evaluation will be made using the RECIST guidelines. Non-target lesions, including bone disease, will only be assessed for CR, incomplete response/SD, and PD.
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Secondary Objective: Assessment of PFS at 12 and 24 months; Time to treatment failure; Time to progression; Overall response rate; Clinical benefit (CR+PR+ SD > 8 wks/24 wks); Duration of response; Time to initiation of subsequent anticancer therapy; Survival; Safety; Health outcomes; Prognostic markers and pharmacogenomics analysis
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Secondary ID(s)
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3066A1-303-WW
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2004-000015-25-SK
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 15/10/2004
Contact:
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