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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 determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive women with first relapse of breast cancer.

Anastrozole monotherapy versus maximal oestrogen blockade with anastrozole and fulvestrant combination therapy

intramuscular injection 250 mg loading dose (LD) regimen

Research Site

FACT: Anastrozole monotherapy versus maximal oestrogen blockade with anastrozole and fulvestrant combination therapy; an open randomized, comparative, Phase III multicentre study in postmenopausal women with hormone receptor positive breast cancer in first relapse after primary treatment of localized tumor.

RECIST (Response Evaluation Criteria in Solid Tumours) assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009.  TTP, time in months to worsen 'progression' according to RECIST criteria. (RECIST is a set of published rules that define when cancer patients improve "respond", stay the same "stable"or worsen "progression" during treatments.

Age Continuous

Gender, Male/Female

Time to Progression (TTP)

No. of patients who were objective responders over the no. of patients evaluable for response x100.  An objective responder = a patient whose best response is either CR (disappearance of all lesions) or PR (>= 30% shrinkage in the sum of the longest diamemeters of the measurable lesions + no new lesions + no progression of non-measurable lesions)

Percentage of evaluable participants with Objective Response Rate (ORR)

No. of patients who were clinical benefit responders over the no. of randomised patients x100.  A clinical benefit responder = a patient whose best response is CR, PR or SD>=24 weeks (where a best response of SD = no new lesions and for existing lesions; neither suffient shrinkage to count as PR nor sufficient growth to count as progression)

Percentage of Clinical Benefit Rate (CBR) responders

Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are objective responders

Duration of Response (DoR)

Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are clinical benefit responders

Duration of Clinical Benefit (DoCB)

Time from randomisation until the date of discontinuation of randomised treatment for any reason

Time to Treatment Failure (TTF)

Overall survival is equivalent to time to death.  Time from randomisation until the date of death

Arms	Assigned Interventions
Active Comparator: 1 Anastrozole	Drug: Anastrozole 1 mg oral tablet Other Name: Arimidex Other Name: ZD1033
Experimental: 2 Anastrozole + Fulvestrant	Drug: Fulvestrant intramuscular injection 250 mg loading dose (LD) regimen Other Name: Faslodex Other Name: ZD9238 Drug: Anastrozole 1 mg oral tablet Other Name: Arimidex Other Name: ZD1033

Anastrozole monotherapy versus maximal oestrogen blockade with anastrozole and fulvestrant combination therapy - FACT

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

US and Canada Only

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=409&filename=CSR-D6997L00002.pdf

CSR-D6997L00002.pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator