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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 multi-centre, randomised, double-blind, parallel-group study is to compare efficacy and safety between anastrozole and tamoxifen in pre- and post-operative administration under goserelin acetate treatment for premenopausal breast cancer patients

Arimidex/Tamoxifen neo adjuvant study in premenopausal patients with breast cancer under anti hormonal treatment

Research Site

Multi-centre, randomised, double-blind, parallel-group study to compare efficacy and safety between anastrozole (ZD1033) and tamoxifen in pre- and post-operative administration under goserelin acetate treatment for premenopausal breast cancer patients

The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period (based on the data from calliper measurement).
CR (or PR) criteria are met at 2 or more time in points every 4 weeks.
Per RECIST Criteria (V1.0) and assessed by Calliper: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period (based on the data from ultra sound (US) measurement).
CR (or PR) criteria are met at 2 or more time in points every 4 weeks.
Per RECIST Criteria (V1.0) and assessed by US: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period(based on the data from magnetic resonance imaging (MRI) or computed tomography (CT) measurement).
CR (or PR) criteria are met at either 12 weeks or 24 weeks.
Per RECIST Criteria (V1.0) and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Age, Customized

Gender, Male/Female

The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period.
At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter

Best Overall Response Rate (BORR) (Calliper)

Best Overall Response Rate (BORR) (US)

Best Overall Response Rate (BORR) (MRI/CT)

Change from baseline in Bone Mineral Density value (percentage), in all subjects who used DXA(Dual-energy X-ray absorptiometry) method throughout the study, at 24 weeks measured at lumbar spine.

The standard BMD value is defined by Japanese Osteoporosis Society in the table of reference values showing the mean for the age, gender, race, skeletal site, and densitometer measurement units was used. Then the formula was used at each measurement data: BMD(%) = Patient's BMD / standard BMD) x 100

Bone Mineral Density (BMD) lumbar spine

Change from baseline in Bone Mineral Density value (percentage), in all subjects who used DXA(Dual-energy X-ray absorptiometry) method throughout the study,  at 24 weeks measured at cervical thighbone.

Difference of percentage Bone Mineral Density (BMD) Cervical Thighbone = BMD percentage at 24 weeks – BMD percentage at baseline

Bone Mineral Density (BMD) cervical thighbone

Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by EIA method

Bone turnover marker (BAP) EIA method

Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by CLEIA method

Bone turnover marker (BAP) CLEIA method

Change from baseline in serum crosslinked N-Telopeptide of type I collagen (NTX) at 24 weeks

Bone turnover marker (NTX)

Ratio of serum Oestrone (E1) concentration (pg/mL) in the ITT population from baseline at 24 weeks.

Serum Oestrone (E1) Concentrations

Ratio of serum Oestradiol (E2) concentration (pg/mL) in the ITT population from baseline at 24 weeks.

Serum Oestradiol (E2) Concentrations

Baseline Positive & 24 weeks Negative

Baseline Positive & 24 weeks Positive

Baseline Negative & 24 weeks Negative

Baseline Negative & 24 weeks Positive

ER status in the ITT population is categorized as Positive or Negative

Oestrogen receptor (ER) status

PgR status in the ITT population is categorized as Positive or Negative.

Progesterone receptor (PgR) status

HER2 status in the ITT population is categorized as Positive or Negative

Human epidermal growth factor receptor 2 (HER2) status

Number of patients in the ITT population defined as histopathological responders over the total number of patients x 100. An histopathological responder = a patient classified as Grade 1b, 2 or 3 for the histopathological response (Grade 0 = no response, 1a = mild response, 1b = moderate response, 2 = marked response or 3 = complete response)

Histopathological response rate (HRR)

Change from baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B)in the ITT population at 24 weeks. Trial Outcome Index (TOI) = the sum of the Physical Well-Being (PWB), Functional Well-Being (FWB), and Breast Cancer Scale (BCS) subscales of FACT-B.
FACT-B includes 36 questions; 7 in PWB (Physical Well-Being); 7 inSWB (Social / Family Well-Being); 6 in EWB (Emotional Well-Being); 7 in FWB (Functional Well-Being); 9 in BCS (Breast Cancer Subscale).
Total score of subscores or TOI is calculated from each score of question. Higher score means better and lower score means worthier.
Score range; 0-28 in PWB; 0-28 in SWB; 0-24 in EWB; 0-28 in FWB; 0-36 in BCS; 0-92 in TOI.

Total score of subscores or TOI is calculated from each score of question. Higher score means better and lower score means worthier.
PWB, FWB and BCS were assessed in this study. TOI was a total of PWB, FWB and BCS.

Functional Assessment of Cancer Therapy-Breast (FACT-B)

Change from baseline in Endocrine Symptom Subscale (ES)) in the ITT population at 24 weeks. ES score = the sum of the responses to all the questions on ES, low scores reflect poor quality of life and high scores reflects better quality of life.

Score range: 0-72

Difference of Endocrine Subscale (ES) = ES at 24 weeks – ES at baseline.

Endocrine Subscale (ES)

Trough Plasma concentrations (Cmin) of Anastrozole - only Anastrozole arm was evaluated for Trough Plasma concentrations.

Anastrozole plasma concentrations (Cmin)

Overall Study

A total of 197 participants were recruited into this study and 98 were randomized to Anastrozole (20 mg once daily oral dose) and 99 were randomized to Tamoxifen (1 mg once daily oral dose) with one subject voluntarily discontinuing prior to receiving treatment Tamoxifen.

Arms	Assigned Interventions
Active Comparator: 1 Tamoxifen	Drug: Tamoxifen 20 mg once daily oral dose Other Name: NOLVADEX Drug: Goserelin acetate (Zoladex) 3.6mg/month depot injection Other Name: ZOLADEX
Experimental: 2 Anastrazole (Arimidex)	Drug: Anastrazole (Arimidex) 1 mg once daily oral dose Other Name: ARIMIDEX Other Name: ZD1033 Drug: Goserelin acetate (Zoladex) 3.6mg/month depot injection Other Name: ZOLADEX

Arimidex/Tamoxifen neo adjuvant study in premenopausal patients with breast cancer under anti hormonal treatment

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

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=381&filename=CSR-D539BC00001.pdf

CSR-D539BC00001.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator