Trial Outcomes & Findings for A Study to Investigate the Biological Effects of AZD9833 in Women With ER-positive, HER2 Negative Primary Breast Cancer (NCT NCT04588298)

Last Updated: 2025-01-24

Results Overview

The pharmacodynamic (PD) effect of AZD9833 on ER expression comparing pre- and on-treatment tumour samples in women with early breast cancer after 5 to 7 days and 12 to 15 days of AZD9833 treatment was assessed. The assessment was done by immunohistochemistry (IHC) method. The percentage change was calculated from an analysis of covariance (ANCVOA) model adjusting for baseline ER score and day of on-treatment biopsy.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

135 participants

Primary outcome timeframe

Baseline (Screening Day -21 to 1) to Biopsy day (Days 5-7 [Stage 1 and 2] or Days 12-15 [Stage 3])

Results posted on

2025-01-24

Participant Flow

The study was conducted at 13 sites in 3 countries between November 2, 2020 and June 19, 2023.

Patients were enrolled according to the inclusion/exclusion criteria, with a 21 day screening period. Assessments were performed as per schedule. The study consists of 3 stages with different patients in each stage. Results pool data from the 75mg and 150mg arms of stages 1 and 2. This is per the predefined statistical analysis plan, which describes the combination of identical treatments in terms of dose and treatment duration. Stage 3 explored a different duration so is reported separately.

Participant milestones

Participant milestones
Measure	AZD9833 75 mg (Stage 1 + 2) Patients received once daily oral dose of AZD9833 75 mg for 5 to 7 days, during the study.	AZD9833 150 mg (Stage 1 + 2) Patients received once daily oral dose of AZD9833 150 mg for 5 to 7 days, during the study.	AZD9833 300 mg (Stage 2) Patients received once daily oral dose of AZD9833 300 mg for 5 to 7 days , during the study	AZD9833 75 mg (Stage 3) Patients received once daily oral dose of AZD9833 75 mg for 12 to 15 days , during the study	AZD9833 150 mg (Stage 3) Patients received once daily oral dose of AZD9833 150 mg for 12 to 15 days , during the study
Overall Study STARTED	30	33	13	30	29
Overall Study COMPLETED	29	33	12	29	27
Overall Study NOT COMPLETED	1	0	1	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	AZD9833 75 mg (Stage 1 + 2) Patients received once daily oral dose of AZD9833 75 mg for 5 to 7 days, during the study.	AZD9833 150 mg (Stage 1 + 2) Patients received once daily oral dose of AZD9833 150 mg for 5 to 7 days, during the study.	AZD9833 300 mg (Stage 2) Patients received once daily oral dose of AZD9833 300 mg for 5 to 7 days , during the study	AZD9833 75 mg (Stage 3) Patients received once daily oral dose of AZD9833 75 mg for 12 to 15 days , during the study	AZD9833 150 mg (Stage 3) Patients received once daily oral dose of AZD9833 150 mg for 12 to 15 days , during the study
Overall Study Adverse Event	0	0	1	0	2
Overall Study Withdrawal by Subject	1	0	0	1	0

Baseline Characteristics

Mean and S.D data for Stage 1, and 2 combined, and stage 2, and stage 3 have been presented in 2 different rows.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AZD9833 75 mg (Stage 1 + 2) n=30 Participants Patients received once daily oral dose of AZD9833 75 mg for 5 to 7 days, during the study.	AZD9833 150 mg (Stage 1 + 2) n=33 Participants Patients received once daily oral dose of AZD9833 150 mg for 5 to 7 days, during the study.	AZD9833 300 mg (Stage 2) n=13 Participants Patients received once daily oral dose of AZD9833 300 mg for 5 to 7 days , during the study	AZD9833 75 mg (Stage 3) n=30 Participants Patients received once daily oral dose of AZD9833 75 mg for 12 to 15 days , during the study	AZD9833 150 mg (Stage 3) n=29 Participants Patients received once daily oral dose of AZD9833 150 mg for 12 to 15 days , during the study	Total n=135 Participants Total of all reporting groups
Age, Continuous	62.0 Years STANDARD_DEVIATION 7.35 • n=99 Participants • Mean and S.D data for Stage 1, and 2 combined, and stage 2, and stage 3 have been presented in 2 different rows.	65.7 Years STANDARD_DEVIATION 7.53 • n=107 Participants • Mean and S.D data for Stage 1, and 2 combined, and stage 2, and stage 3 have been presented in 2 different rows.	66.3 Years STANDARD_DEVIATION 8.20 • n=206 Participants • Mean and S.D data for Stage 1, and 2 combined, and stage 2, and stage 3 have been presented in 2 different rows.	64.0 Years STANDARD_DEVIATION 8.65 • n=7 Participants • Mean and S.D data for Stage 1, and 2 combined, and stage 2, and stage 3 have been presented in 2 different rows.	67.2 Years STANDARD_DEVIATION 10.03 • n=31 Participants • Mean and S.D data for Stage 1, and 2 combined, and stage 2, and stage 3 have been presented in 2 different rows.	64.9 Years STANDARD_DEVIATION 8.49 • n=30 Participants • Mean and S.D data for Stage 1, and 2 combined, and stage 2, and stage 3 have been presented in 2 different rows.
Sex: Female, Male Female	30 Participants n=99 Participants	33 Participants n=107 Participants	13 Participants n=206 Participants	30 Participants n=7 Participants	29 Participants n=31 Participants	135 Participants n=30 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) White	30 Participants n=99 Participants	33 Participants n=107 Participants	13 Participants n=206 Participants	30 Participants n=7 Participants	29 Participants n=31 Participants	135 Participants n=30 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	4 Participants n=7 Participants	5 Participants n=31 Participants	9 Participants n=30 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	29 Participants n=99 Participants	32 Participants n=107 Participants	13 Participants n=206 Participants	26 Participants n=7 Participants	24 Participants n=31 Participants	124 Participants n=30 Participants
Race/Ethnicity, Customized Other	1 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	2 Participants n=30 Participants

PRIMARY outcome

Timeframe: Baseline (Screening Day -21 to 1) to Biopsy day (Days 5-7 [Stage 1 and 2] or Days 12-15 [Stage 3])

Population: PD analysis set included: all the patient who had taken at least 5 consecutive daily doses (Stage 1 and 2) or at least 12 consecutive daily doses (Stage 3) of AZD9833. The patient received last AZD9833 dose within 12 hours of the on-treatment biopsy, diagnostic and on-treatment biopsy pair was considered evaluable by central pathology assessment (\>100 tumor cells per FFPE biopsy, and minimum of 2 slides for ER measurement), with no protocol deviations affecting the biomarker analysis.

Outcome measures

Outcome measures
Measure	AZD9833 75 mg (Stage 1 + 2) n=26 Participants Patients received once daily oral dose of AZD9833 75 mg for 5 to 7 days, during the study.	AZD9833 150 mg (Stage 1 + 2) n=31 Participants Patients received once daily oral dose of AZD9833 150 mg for 5 to 7 days, during the study.	AZD9833 300 mg (Stage 2) n=11 Participants Patients received once daily oral dose of AZD9833 300 mg for 5 to 7 days , during the study	AZD9833 75 mg (Stage 3) n=24 Participants Patients received once daily oral dose of AZD9833 75 mg for 12 to 15 days , during the study	AZD9833 150 mg (Stage 3) n=26 Participants Patients received once daily oral dose of AZD9833 150 mg for 12 to 15 days , during the study
Percentage Change From Baseline in Estrogen Receptor (ER) Expression Between Pre- and On-treatment Tumour Samples (Primary Analysis)	-62.7 Percentage change from baseline Interval -67.46 to -57.93	-62.8 Percentage change from baseline Interval -67.13 to -58.43	-67.1 Percentage change from baseline Interval -74.49 to -59.74	-66.9 Percentage change from baseline Interval -72.34 to -61.46	-65.0 Percentage change from baseline Interval -70.27 to -59.81

PRIMARY outcome

Timeframe: Baseline (Screening Day -21 to 1) to Biopsy Day (Days 5-7 [Stage 1 and 2] or Days 12-15 [Stage 3])

The PD effect of AZD9833 on ER expression comparing pre- and on-treatment tumour samples in women with early breast cancer after 5 to 7 days and 12 to 15 days of AZD9833 treatment was assessed. The assessment was done by IHC method. The sensitivity analysis excluded any patients who were HER2-positive patient by central assessment as well as patients with baseline ER H-score \< 10. The percentage change was calculated from ANCVOA model adjusting for baseline ER score and day of on-treatment biopsy.

Outcome measures

Outcome measures
Measure	AZD9833 75 mg (Stage 1 + 2) n=25 Participants Patients received once daily oral dose of AZD9833 75 mg for 5 to 7 days, during the study.	AZD9833 150 mg (Stage 1 + 2) n=31 Participants Patients received once daily oral dose of AZD9833 150 mg for 5 to 7 days, during the study.	AZD9833 300 mg (Stage 2) n=11 Participants Patients received once daily oral dose of AZD9833 300 mg for 5 to 7 days , during the study	AZD9833 75 mg (Stage 3) n=24 Participants Patients received once daily oral dose of AZD9833 75 mg for 12 to 15 days , during the study	AZD9833 150 mg (Stage 3) n=26 Participants Patients received once daily oral dose of AZD9833 150 mg for 12 to 15 days , during the study
Percentage Change From Baseline in ER Expression Between Pre- and On-treatment Tumour Samples (Sensitivity Analysis)	-62.1 Percentage change from baseline Interval -67.0 to -57.25	-62.3 Percentage change from baseline Interval -66.64 to -57.88	-66.6 Percentage change from baseline Interval -74.0 to -59.14	-66.9 Percentage change from baseline Interval -72.34 to -61.46	-65.0 Percentage change from baseline Interval -70.27 to -59.81

SECONDARY outcome

Timeframe: Baseline (Screening Day -21 to 1) to Biopsy Day (Days 5-7 [Stage 1 and 2] or Days 12-15 [Stage 3])

Population: PD analysis set included: all the patient who had taken at least 5 consecutive daily doses (Stage 1 and 2) or at least 12 consecutive daily doses (Stage 3) of AZD9833. The patient received last AZD9833 dose within 12 hours of the on-treatment biopsy, diagnostic and on-treatment biopsy pair was considered evaluable by central pathology assessment (\>100 tumor cells per FFPE biopsy, and minimum of 2 slides for PgR measurement), with no protocol deviations affecting the biomarker analysis.

The PD effects of AZD9833 on PgR expression comparing pre- and on-treatment tumour samples in women with early breast cancer after 5 to 7 days and 12 to 15 days of AZD9833 treatment was assessed. The assessment was done by IHC method. The percentage change was calculated from an ANCOVA model adjusting for baseline PgR score and day of on-treatment biopsy.

Outcome measures

Outcome measures
Measure	AZD9833 75 mg (Stage 1 + 2) n=26 Participants Patients received once daily oral dose of AZD9833 75 mg for 5 to 7 days, during the study.	AZD9833 150 mg (Stage 1 + 2) n=31 Participants Patients received once daily oral dose of AZD9833 150 mg for 5 to 7 days, during the study.	AZD9833 300 mg (Stage 2) n=11 Participants Patients received once daily oral dose of AZD9833 300 mg for 5 to 7 days , during the study	AZD9833 75 mg (Stage 3) n=24 Participants Patients received once daily oral dose of AZD9833 75 mg for 12 to 15 days , during the study	AZD9833 150 mg (Stage 3) n=26 Participants Patients received once daily oral dose of AZD9833 150 mg for 12 to 15 days , during the study
Percentage Change From Baseline in Progesterone Receptor (PgR) Expression Between Pre- and On-treatment Tumour Samples (Primary Analysis)	194.8 Percentage change from baseline Interval 25.5 to 364.03	-3.0 Percentage change from baseline Interval -158.37 to 152.36	170.3 Percentage change from baseline Interval -89.67 to 430.33	-24.2 Percentage change from baseline Interval -547.03 to 498.69	463.8 Percentage change from baseline Interval -38.45 to 966.02

SECONDARY outcome

Timeframe: Baseline (Screening Day -21 to 1) to Biopsy day (Days 5-7 [Stage 1 and 2] or Days 12-15 [Stage 3])

Population: PD analysis set included: all the patient who had taken at least 5 consecutive daily doses (Stage 1 and 2) or at least 12 consecutive daily doses (Stage 3) of AZD9833. The patient received last AZD9833 dose within 12 hours of the on-treatment biopsy, diagnostic and on-treatment biopsy pair was considered evaluable by central pathology assessment (\>100 tumor cells per FFPE biopsy, and minimum of 2 slides for PgR measurement), with no protocol deviations affecting the biomarker analysis.

The PD effects of AZD9833 on PgR expression comparing pre- and on-treatment tumour samples in women with early breast cancer after 5 to 7 days and 12 to 15 days of AZD9833 treatment was assessed. The assessment was done by IHC method. The sensitivity analysis excluded any patients who were HER2-positive patient by central assessment as well as patients with baseline PgR H-score \< 10. The percentage change was calculated from an ANCOVA model adjusting for baseline PgR score and day of on-treatment biopsy.

Outcome measures

Outcome measures
Measure	AZD9833 75 mg (Stage 1 + 2) n=19 Participants Patients received once daily oral dose of AZD9833 75 mg for 5 to 7 days, during the study.	AZD9833 150 mg (Stage 1 + 2) n=26 Participants Patients received once daily oral dose of AZD9833 150 mg for 5 to 7 days, during the study.	AZD9833 300 mg (Stage 2) n=8 Participants Patients received once daily oral dose of AZD9833 300 mg for 5 to 7 days , during the study	AZD9833 75 mg (Stage 3) n=23 Participants Patients received once daily oral dose of AZD9833 75 mg for 12 to 15 days , during the study	AZD9833 150 mg (Stage 3) n=20 Participants Patients received once daily oral dose of AZD9833 150 mg for 12 to 15 days , during the study
Percentage Change From Baseline in PgR Expression Between Pre- and On-treatment Tumour Samples (Sensitivity Analysis)	-35.2 Percentage change from baseline Interval -45.86 to -24.57	-44.0 Percentage change from baseline Interval -53.09 to -34.9	-36.7 Percentage change from baseline Interval -52.96 to -20.52	-61.8 Percentage change from baseline Interval -76.93 to -46.62	-55.0 Percentage change from baseline Interval -71.29 to -38.78

SECONDARY outcome

Timeframe: Baseline (Screening Day -21 to 1) to Biopsy day (Days 5-7 [Stage 1 and 2] or Days 12-15 [Stage 3])

Population: PD analysis set included: all the patient who had taken at least 5 consecutive daily doses (Stage 1 and 2) or at least 12 consecutive daily doses (Stage 3) of AZD9833. The patient received last AZD9833 dose within 12 hours of the on-treatment biopsy, diagnostic and on-treatment biopsy pair was considered evaluable by central pathology assessment (\>100 tumor cells per FFPE biopsy, and minimum of 2 slides for Ki-67 measurement), with no protocol deviations affecting the biomarker analysis.

The PD effect of AZD9833 on antigen Ki-67 expression comparing pre- and on-treatment tumour samples in women with early breast cancer after 5 to 7 days and 12 to 15 days of AZD9833 treatment was assessed. The assessment was done by IHC method. The percentage change was calculated from an ANCOVA model adjusting for log baseline Ki67 index and day of on-treatment biopsy. The Ki-67 index data were log transformed prior to analysis, with results back-transformed to represent percentage change.

Outcome measures

Outcome measures
Measure	AZD9833 75 mg (Stage 1 + 2) n=26 Participants Patients received once daily oral dose of AZD9833 75 mg for 5 to 7 days, during the study.	AZD9833 150 mg (Stage 1 + 2) n=31 Participants Patients received once daily oral dose of AZD9833 150 mg for 5 to 7 days, during the study.	AZD9833 300 mg (Stage 2) n=11 Participants Patients received once daily oral dose of AZD9833 300 mg for 5 to 7 days , during the study	AZD9833 75 mg (Stage 3) n=24 Participants Patients received once daily oral dose of AZD9833 75 mg for 12 to 15 days , during the study	AZD9833 150 mg (Stage 3) n=26 Participants Patients received once daily oral dose of AZD9833 150 mg for 12 to 15 days , during the study
Percentage Change From Baseline in Ki-67 Labelling Index Between Pre- and On-treatment Tumour Samples (Primary Analysis)	-40.3 Percentage change from baseline Interval -52.78 to -24.49	-79.4 Percentage change from baseline Interval -83.37 to -74.55	-78.2 Percentage change from baseline Interval -84.82 to -68.77	-73.0 Percentage change from baseline Interval -79.42 to -64.64	-77.5 Percentage change from baseline Interval -82.68 to -70.86

SECONDARY outcome

Timeframe: Baseline (Screening Day -21 to 1) to Biopsy Day (Days 5-7 [Stage 1 and 2] or Days 12-15 [Stage 3])

Population: PD analysis set included: all the patient who had taken at least 5 consecutive daily doses (Stage 1 and 2) or at least 12 consecutive daily doses (Stage 3) of AZD9833. The patient received last AZD9833 dose within 12 hours of the on-treatment biopsy, diagnostic and on-treatment biopsy pair was considered evaluable by central pathology assessment (\>100 tumor cells per FFPE biopsy, and minimum of 2 slides for ki-67 measurement), with no protocol deviations affecting the biomarker analysis.

The PD effect of AZD9833 on antigen Ki-67 expression comparing pre- and on-treatment tumour samples in women with early breast cancer after 5 to 7 days and 12 to 15 days of AZD9833 treatment was assessed. The assessment was done by IHC method. The sensitivity analysis excluded any patients who were HER2-positive patient by central assessment as well as patients with baseline Ki67 labelling index \<5%. The percentage change was calculated from an ANCOVA model adjusting for log baseline Ki67 index and day of on-treatment biopsy. The Ki-67 index data were log transformed prior to analysis, with results back-transformed to represent percentage change.

Outcome measures

Outcome measures
Measure	AZD9833 75 mg (Stage 1 + 2) n=17 Participants Patients received once daily oral dose of AZD9833 75 mg for 5 to 7 days, during the study.	AZD9833 150 mg (Stage 1 + 2) n=28 Participants Patients received once daily oral dose of AZD9833 150 mg for 5 to 7 days, during the study.	AZD9833 300 mg (Stage 2) n=11 Participants Patients received once daily oral dose of AZD9833 300 mg for 5 to 7 days , during the study	AZD9833 75 mg (Stage 3) n=18 Participants Patients received once daily oral dose of AZD9833 75 mg for 12 to 15 days , during the study	AZD9833 150 mg (Stage 3) n=20 Participants Patients received once daily oral dose of AZD9833 150 mg for 12 to 15 days , during the study
Percentage Change From Baseline in Ki-67 Labelling Index Between Pre- and On-treatment Tumour Samples (Sensitivity Analysis)	-49.3 Percentage change from baseline Interval -62.18 to -31.96	-81.3 Percentage change from baseline Interval -85.14 to -76.49	-78.9 Percentage change from baseline Interval -85.37 to -69.46	-81.7 Percentage change from baseline Interval -86.45 to -75.24	-81.9 Percentage change from baseline Interval -86.38 to -75.88

SECONDARY outcome

Timeframe: From screening (Day -21 to 1) through 28-day follow-up (Upto 2 months)

Population: Safety Analysis Set is defined as all patients who received any amount of study treatment, regardless of whether that was the randomized therapy at intended.

The safety and tolerability of AZD9833 in this patient population was evaluated.

Outcome measures

Outcome measures
Measure	AZD9833 75 mg (Stage 1 + 2) n=30 Participants Patients received once daily oral dose of AZD9833 75 mg for 5 to 7 days, during the study.	AZD9833 150 mg (Stage 1 + 2) n=33 Participants Patients received once daily oral dose of AZD9833 150 mg for 5 to 7 days, during the study.	AZD9833 300 mg (Stage 2) n=13 Participants Patients received once daily oral dose of AZD9833 300 mg for 5 to 7 days , during the study	AZD9833 75 mg (Stage 3) n=30 Participants Patients received once daily oral dose of AZD9833 75 mg for 12 to 15 days , during the study	AZD9833 150 mg (Stage 3) n=29 Participants Patients received once daily oral dose of AZD9833 150 mg for 12 to 15 days , during the study
Number of Patients With Adverse Events (AEs) Any AE	9 Participants	17 Participants	9 Participants	11 Participants	19 Participants
Number of Patients With Adverse Events (AEs) Any SAE leading to discontinuation of treatment	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Patients With Adverse Events (AEs) Any AE possibly related to treatment	4 Participants	14 Participants	6 Participants	10 Participants	17 Participants
Number of Patients With Adverse Events (AEs) Any AE of CTCAE grade 3 or higher	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Patients With Adverse Events (AEs) Any AE of CTCAE grade 3 or higher, possibly related to treatment	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Patients With Adverse Events (AEs) Any AE with outcome = death	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Patients With Adverse Events (AEs) Any AE with outcome = death, possibly related to treatment	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Patients With Adverse Events (AEs) Any SAE (including events with outcome = death)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Patients With Adverse Events (AEs) Any SAE (including events with outcome = death), possibly related to treatment	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Patients With Adverse Events (AEs) Any SAE leading to discontinuation of treatment, possibly related to treatment	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Patients With Adverse Events (AEs) Any AE leading to discontinuation of treatment	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Number of Patients With Adverse Events (AEs) Any AE leading to discontinuation of treatment, possibly related to treatment	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Patients With Adverse Events (AEs) Any AE leading to dose modification of treatment	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Patients With Adverse Events (AEs) Any AE leading to dose modification of treatment, possibly related to treatment	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Patients With Adverse Events (AEs) Any other significant AEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Days 5-7 or Days 12-15 (Pre and Post biopsy)

Population: The Pharmacokinetic (PK) Analysis Set is defined as all patients who received at least one dose of AZD9833 per protocol, for whom there is at least one reportable PK concentration.

The plasma concentration of AZD9833 in this participant population was evaluated