Hormone receptor positive breast cancer with disease progression after prior non-steroidal aromatase inhibitor (AI) therapy
Conditions
Interventions
Trade Name: Faslodex 250 mg/5 ml solution for injection
Product Name: Faslodex 250 mg/5 ml solution for injection
Product Code: EU/1/03/269/001
Pharmaceutical Form: Solution for injection
INN or Propo
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histological/cytological confirmation of breast cancer. 2. Objective evidence of recurrence or progression of disease, which is not considered amenable to curative treatment. 3. Postmenopausal woman, defined as a woman fulfilling any 1 of the following criteria: - Age = 60 years - Age = 45 years with amenorrhea for =12 months with an intact uterus - Follicle-stimulating hormone (FSH) levels in post menopausal range (utilizing ranges from the testing laboratory facility). If previous treatment with luteinizing hormone-releasing hormone (LH-RH) analogue, then the last depot of LH-RH analog must have been administered greater than 4 months prior to randomization and menses must not have restarted. - Having undergone a bilateral oophorectomy 4. Progression while receiving a non-steroidal AI for locally advanced or metastatic breast cancer or recurrence while receiving a non-steroidal AI as adjuvant therapy or within 6 months of treatment discontinuation. Note: Patients who received only one chemotherapy regimen for advanced disease prior to receiving a non-steroidal AI are allowed. 5. Evidence of hormone sensitivity either ER+ and/or PgR+. 6. Patients fulfilling one of the following criteria are eligible to participate in this study: - Patients with measurable disease as per RECIST criteria. This is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as = 20 mm with conventional technique or as = 10 mm with spiral CT scan or MRI. - Patients with bone lesions, lytic or mixed (lytic + sclerotic), in the absence of measurable disease as defined by RECIST criteria. 7. Performance status of 0, 1, or 2. 8. Written informed consent to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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
Exclusion criteria: 1. Previous treatment with fulvestrant or exemestane. 2. Extensive radiotherapy within previous 4 weeks (greater than or equal to 30% of marrow-bearing bone, eg, whole pelvis or half spine). Strontium-90 (or other radiopharmaceutical) within previous 3 months. 3. Current or previously active systemic malignancy within 3 years prior to randomization (other than breast cancer, or adequately treated in-situ carcinoma of the cervix, uteri, or basal or squamous cell carcinoma of the skin). 4. Any intercurrent systemic anti-cancer therapy after prior non-steroidal AI therapy. 5. Currently receiving (and are unwilling to discontinue) hormone replacement therapy. 6. Laboratory results sustained at: - Platelets 1.6 - Total bilirubin > 1.5 x ULRR - ALT or AST >2.5 x ULRR if no demonstrable liver metastases or >5 x ULRR in presence of liver metastases No more than 3 retests within screening period 7. Risk (in the investigator’s opinion) of transmitting human immunodeficiency virus, hepatitis B or C, through blood or other bodily fluids. 8. History of: - bleeding diathesis (ie, disseminated intravascular coagulation [DIC], clotting factor deficiency) or - long-term anticoagulant therapy (other than antiplatelet therapy). 9. Non-approved/experimental drug treatment within previous 4 weeks before randomization. 10. Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol eg, severe renal or hepatic impairment or currently unstable or uncompensated respiratory or cardiac conditions. 11. History of hypersensitivity to active or inactive excipients of fulvestrant and/or exemestane (ie castor oil or Mannitol). 12. Presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, or any degree of brain or leptomeningeal involvement (past or present), or symptomatic pulmonary lymphangitic spread. Subjects with discrete pulmonary parenchymal metastases are eligible, provided their respiratory function is not compromised as a result of disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of AstraZeneca ZD9238 (fulvestrant, FASLODEX™) vs exemestane (AROMASIN™, Pharmacia & Upjohn) in hormone receptor-positive postmenopausal women with breast cancer progression after prior non-steroidal aromatase inhibitor (AI) therapy, by evaluation of time to disease progression (TTP).;Secondary Objective: To compare objective response (OR) rates (complete response [CR] + partial response [PR]), duration of response (DoR), clinical benefit rate (CB), overall survival (OS), tolerability, quality of life (QoL), and health care resource use between the patients described above on fulvestrant and those on exemestane.;Primary end point(s): The primary endpoint of TTP is defined as the time from randomization to the time of the earliest evidence of disease progression or death from any cause. Patients who have not progressed or died at the time of the data cut-off date or who have been lost to follow-up will be right-censored at the date of their last disease assessment. Patients will be considered lost to follow-up if they have missed visits and there is no follow-up available for more than 6 months. | — |
Countries
Hungary
Outcome results
None listed