EU Clinical Trial Information System (CTIS)

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

The purpose of this study is to compare the efficacy and tolerability of Faslodex (fulvestrant) with Arimidex (anastrozole) in postmenopausal women with hormone receptor positive advanced breast cancer.

A clinical trial to compare efficacy and tolerability of Faslodex with Arimidex in patients with advanced breast cancer

NCT ID

Patient Level Data

Therapeutic Area

D6995C00006FIRSToverall_survivalRevisedCSP_4_10_December_2014_Redacted

Research Site

A Randomized, Open-Label, Parallel-Group, Multicentre, Phase II Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg with Anastrozole (ARIMIDEX™) 1 mg as First Line Hormonal Treatment for Postmenopausal Women with Hormone Receptor Positive Advanced Breast Cancer

A Clinical Benefit (CB) responder is defined as a patient having a best overall response ofCR, PR or SD provided SD (or better) was present ≥ 154 days from randomization (ie SD ≥ 24weeks with the 2 week RECIST assessment time window allowed). The Clinical Benefit Rate is the percentage of patients with CB

Age Continuous

Sex: Female, Male

One patient in the ITT population was randomized to Fulvestrant 500 but did not receive drug and was excluded from the safety population. Hence, the safety population for Fulvestrant contained 101 patients.

A Clinical Benefit (CB) responder is defined as a patient having a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) for at least 24 weeks evaluated according to modified RECIST. The Clinical Benefit Rate is the percentage of patients with CB.

Clinical Benefit Rate

For each patient with measurable disease at baseline, the determination of the overall response for each visit was carried out using a SAS program per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete Response (CR): Disappearance of all target lesion (TL) and non-target lesions (NTLs) and no new lesions. Partial Response (PR): At least a 30% decrease in the sum of longest diameter of TLs (compared to baseline), no progression of NTLs and no new lesions. Objective response rate is defined as percentage of patients  with either CR or PR.

Objective Response Rate

Time from randomization until earlier of disease progression or death. Progression was defined according to  RECIST: a patient is determined to have progressed if they have progression of target lesions, clear progression of existing non-target lesions, or the appearance of one or more new lesions. Progression of target lesions is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum of LD recorded. Kaplan-Meier estimates of median for each treatment are reported.

Time to progression

Time from randomization to treatment discontinuation

Time to treatment failure

Time from randomization to disease progression (investigator assessed) or death from any cause. Progression was defined by investigator opinion, as patients did not have formal RECIST visits in the follow-up period after the data cut off for the primary analysis of the study.

Time to progression (investigator assessed)

Time from randomization to death (any cause)

Overall Survival

Overall Study

28 of the 233 enrolled patients were not randomized to treatment groups for the following reasons - 20 patients were incorrectly enrolled (ie did not comply with inclusion / exclusion criteria), 1 died, 1 had an adverse event, 4 voluntarily discontinued, 2 patients were not randomized for other non-specified reasons.

Jasmine Lichfield

An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CRif she had overall response of CR or PR on one visit and met the confirmation criteria perRECIST. ORR is defined as percentage of patients  with objective response.

Time from randomization until earlier of disease progression or death

Time from first response to disease progression or death measured only in those patients who achieved a confirmed Complete Response or confirmed Partial Response

Time from randomization until earlier of disease progression or death measured only in those patients who achieved clinical benefit.Time from randomization until earlier of disease progression or death measured only in those patients who achieved clinical benefit.

Arms	Assigned Interventions
Experimental: 1 Fulvestrant	Drug: fulvestrant 500 mg intramuscular injection Other Name: Faslodex Other Name: ZD9238
Active Comparator: 2 Anastrozole	Drug: anastrozole 1 mg oral tablet Other Name: Arimidex Other Name: ZD1033

A clinical trial to compare efficacy and tolerability of Faslodex with Arimidex in patients with advanced breast cancer - FIRST

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Documents available

CSR-D6995C00006.pdf

D6995C00006FIRSToverall_survivalRevisedCSP_4_10_December_2014_Redacted

Trial Results Summaries

Contacts

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