Trial Outcomes & Findings for A Pharmacokinetic and Randomized Trial of Neoadjuvant Treatment With Anastrozole Plus AZD0530 in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer (NCT NCT01216176)

Last Updated: 2025-01-08

Results Overview

To identify a well tolerated dose of AZD0530 (saracatinib) that can be used together with anastrozole in the Phase 2 trial with tolerable toxicity and PK, subjects were followed as AEs recorded and evaluated and drug concentrations were in the therapeutic range.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

71 participants

Primary outcome timeframe

Cycle 1: Days 1 - 28

Results posted on

2025-01-08

Participant Flow

For the Phase 1 cohort, all 12/12 planned subjects were accrued. Of the planned 60 subjects for Phase 2, 59 subjects were accrued. One was removed from study within a few days ( MD discretion) and is not included in subsequent analysis.

Participant milestones

Participant milestones
Measure	Phase 1 - Cohort A Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer Anastrozole AZD0530	Phase 2 - Cohort B [Anastrozole + AZD0530] Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression or 4-6 months of treatment completed. Anastrozole AZD0530	Phase 2 - Cohort B [Anastrozole + Placebo] Dual treatment with 1 mg anastrozole orally once daily together with Placebo orally once daily, or as specified per protocol, until disease progression or4-6 months of treatment completed. Anastrozole Placebo
Overall Study STARTED	12	39	20
Overall Study COMPLETED	12	31	19
Overall Study NOT COMPLETED	0	8	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1 - Cohort A Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer Anastrozole AZD0530	Phase 2 - Cohort B [Anastrozole + AZD0530] Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression or 4-6 months of treatment completed. Anastrozole AZD0530	Phase 2 - Cohort B [Anastrozole + Placebo] Dual treatment with 1 mg anastrozole orally once daily together with Placebo orally once daily, or as specified per protocol, until disease progression or4-6 months of treatment completed. Anastrozole Placebo
Overall Study Adverse Event	0	8	0
Overall Study Physician Decision	0	0	1

Baseline Characteristics

A Pharmacokinetic and Randomized Trial of Neoadjuvant Treatment With Anastrozole Plus AZD0530 in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1 - Cohort A n=12 Participants Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer Anastrozole AZD0530	Phase 2 - Cohort B [Anastrozole + AZD0530] n=39 Participants Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression or 4-6 months of treatment completed. Anastrozole AZD0530	Phase 2 - Cohort B [Anastrozole + Placebo] n=20 Participants Dual treatment with 1 mg anastrozole orally once daily together with Placebo orally once daily, or as specified per protocol, until disease progression or4-6 months of treatment completed. Anastrozole Placebo	Total n=71 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	28 Participants n=7 Participants	16 Participants n=5 Participants	55 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	11 Participants n=7 Participants	4 Participants n=5 Participants	16 Participants n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	39 Participants n=7 Participants	20 Participants n=5 Participants	71 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethnicity · Non-Hispanic white	9 Participants n=5 Participants	9 Participants n=7 Participants	1 Participants n=5 Participants	19 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethnicity · Non-Hispanic black or African America	0 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	3 Participants n=5 Participants	24 Participants n=7 Participants	12 Participants n=5 Participants	39 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants

PRIMARY outcome

Timeframe: Cycle 1: Days 1 - 28

Population: All participants enrolled to phase 1.

Outcome measures

Outcome measures
Measure	Phase 1 - Cohort A n=12 Participants Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer Anastrozole AZD0530	Phase 2 - Cohort B [Anastrozole + Placebo] Dual treatment with 1 mg anastrozole orally once daily together with Placebo orally once daily, or as specified per protocol, until disease progression or4-6 months of treatment completed. Anastrozole Placebo
Phase I Cohort A: Maximum Tolerated AZD0530 Daily Dose Used in Combination With Daily Oral Anastrozole anastrozole	1 mg/day oral dose	—
Phase I Cohort A: Maximum Tolerated AZD0530 Daily Dose Used in Combination With Daily Oral Anastrozole saracatinib	175 mg/day oral dose	—

PRIMARY outcome

Timeframe: Baseline, cycle 6

Population: Of 59 subjects, 2 (one/arm)tumors were not palpable at baseline; 1 was removed at MD discretion; 8 removed due to AEs . 48 (30+18) completed 4 mo of therapy and were evaluable for clinical response. Subjects completing 4 months were permitted to go tor surgery. At 24 weeks 19 dual and 16 monotherapy remained evaluable for clinical tumor size.

Clinical response is defined as percentage change in tumor size calculated from bi-dimensional clinical tumor measurement at diagnosis and on completion of neoadjuvant treatment. The mean reduction in tumor size ( +/-SD) will be derived form the change in largest tumor dimension ( RECIST) and by calculated tumor volume

Outcome measures

Outcome measures
Measure	Phase 1 - Cohort A n=19 Participants Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer Anastrozole AZD0530	Phase 2 - Cohort B [Anastrozole + Placebo] n=16 Participants Dual treatment with 1 mg anastrozole orally once daily together with Placebo orally once daily, or as specified per protocol, until disease progression or4-6 months of treatment completed. Anastrozole Placebo
Phase II - Cohort B: Compare Treatment Groups (AZD0530 + Anastrozole Versus Anastrozole With Placebo) With Respect to Clinical Response Max clinical diameter % change	-61.5 percentage of tumor volume change Standard Deviation 22.5	-62.3 percentage of tumor volume change Standard Deviation 25
Phase II - Cohort B: Compare Treatment Groups (AZD0530 + Anastrozole Versus Anastrozole With Placebo) With Respect to Clinical Response Clinical tumor volume% change	-87.9 percentage of tumor volume change Standard Deviation 22.6	-90.7 percentage of tumor volume change Standard Deviation 11.8

SECONDARY outcome

Timeframe: 0 hrs, 6 hrs, 12 hrs, 24hrs, 48 hrs, 72 hrs, 8 days, 15 days, 22 days after first dose of AZD0530

Population: Day 21 - 1 missing sample.

Summarized as mean plasma concentrations (ng/ml) of each drug (AZD0530 (saracatinib) and Anastrozole) after exposure to dual therapy.

Outcome measures

Outcome measures
Measure	Phase 1 - Cohort A n=12 Participants Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer Anastrozole AZD0530	Phase 2 - Cohort B [Anastrozole + Placebo] Dual treatment with 1 mg anastrozole orally once daily together with Placebo orally once daily, or as specified per protocol, until disease progression or4-6 months of treatment completed. Anastrozole Placebo
Phase I - Cohort A: Plasma Concentrations of AZD0530 (Saracatinib) and Anastrozole AZD0530 - Cycle 1: 0 hrs	0 ng/ml Standard Deviation 0	—
Phase I - Cohort A: Plasma Concentrations of AZD0530 (Saracatinib) and Anastrozole AZD0530 - Cycle 1: 6 hrs	127.47 ng/ml Standard Deviation 57.12	—
Phase I - Cohort A: Plasma Concentrations of AZD0530 (Saracatinib) and Anastrozole AZD0530 - Cycle 1: 12 hrs	79.1 ng/ml Standard Deviation 33.42	—
Phase I - Cohort A: Plasma Concentrations of AZD0530 (Saracatinib) and Anastrozole AZD0530 - Cycle 1: 24 hrs	46.17 ng/ml Standard Deviation 24.86	—
Phase I - Cohort A: Plasma Concentrations of AZD0530 (Saracatinib) and Anastrozole AZD0530 - Cycle 1: 48 hrs	91.33 ng/ml Standard Deviation 39.60	—
Phase I - Cohort A: Plasma Concentrations of AZD0530 (Saracatinib) and Anastrozole AZD0530 - Cycle 1: 72 hrs	125.49 ng/ml Standard Deviation 52.63	—
Phase I - Cohort A: Plasma Concentrations of AZD0530 (Saracatinib) and Anastrozole AZD0530 - Day 8	232.23 ng/ml Standard Deviation 91.54	—
Phase I - Cohort A: Plasma Concentrations of AZD0530 (Saracatinib) and Anastrozole AZD0530 - Day 15	213.52 ng/ml Standard Deviation 84.13	—
Phase I - Cohort A: Plasma Concentrations of AZD0530 (Saracatinib) and Anastrozole AZD0530 - Day 22	271.97 ng/ml Standard Deviation 144.07	—
Phase I - Cohort A: Plasma Concentrations of AZD0530 (Saracatinib) and Anastrozole Anastrozole - Day 1: 0 hrs	26.35 ng/ml Standard Deviation 11.55	—
Phase I - Cohort A: Plasma Concentrations of AZD0530 (Saracatinib) and Anastrozole Anastrozole - Day 1: 6 hrs	38.2 ng/ml Standard Deviation 26.88	—
Phase I - Cohort A: Plasma Concentrations of AZD0530 (Saracatinib) and Anastrozole Anastrozole - Day 1: 12 hrs	33.45 ng/ml Standard Deviation 22.13	—
Phase I - Cohort A: Plasma Concentrations of AZD0530 (Saracatinib) and Anastrozole Anastrozole - (24 hrs)	29.33 ng/ml Standard Deviation 21.49	—
Phase I - Cohort A: Plasma Concentrations of AZD0530 (Saracatinib) and Anastrozole Anastrozole - (48 hrs)	32.81 ng/ml Standard Deviation 25.15	—
Phase I - Cohort A: Plasma Concentrations of AZD0530 (Saracatinib) and Anastrozole Anastrozole - (72 hrs)	34.08 ng/ml Standard Deviation 20.01	—
Phase I - Cohort A: Plasma Concentrations of AZD0530 (Saracatinib) and Anastrozole Anastrozole - Day 8	51.00 ng/ml Standard Deviation 22.69	—
Phase I - Cohort A: Plasma Concentrations of AZD0530 (Saracatinib) and Anastrozole Anastrozole - Day 15	46.75 ng/ml Standard Deviation 28.07	—
Phase I - Cohort A: Plasma Concentrations of AZD0530 (Saracatinib) and Anastrozole Anastrozole - Day 22	47.33 ng/ml Standard Deviation 25.15	—

SECONDARY outcome

Timeframe: 0 hrs, 6 hrs, 12 hrs, 24hrs, 48 hrs, 72 hrs, 7 days, 14 days, 21 days after first dose of AZD0530

Summarized as the geometric means and standard deviations for the corresponding for peak plasma concentration of each study drug ( AZD0530 (saracatinib) and anastrozole) after exposure

Outcome measures

Outcome measures
Measure	Phase 1 - Cohort A n=12 Participants Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer Anastrozole AZD0530	Phase 2 - Cohort B [Anastrozole + Placebo] Dual treatment with 1 mg anastrozole orally once daily together with Placebo orally once daily, or as specified per protocol, until disease progression or4-6 months of treatment completed. Anastrozole Placebo
Phase 1-Cohort A: Peak Concentration of Each Study Drug ( AZD0530 (Saracatinib) and Anastrozole) AZD0530 (saracatinib) ng/ml	271.97 ng/ml Standard Deviation 144.07	—
Phase 1-Cohort A: Peak Concentration of Each Study Drug ( AZD0530 (Saracatinib) and Anastrozole) anastrozole ng/ml	47.33 ng/ml Standard Deviation 25.15	—

SECONDARY outcome

Timeframe: Baseline to 10 weeks;and baseline to 6 months

Population: Of 59 subjects, 1 was removed at MD discretion; 8 removed due to AEs. Of the remaining 50 (31 dual + 19 mono), all had MRI at 10 weeks. 3 dual and 1 mono had disease progression and no further MRIs. 7 out of 28 (dual) \& 2 out 18 (mono) completing 4 months, had end of study MRI at wk 18; 21 ( dual) and 16 (mono) had a final MRI at 24 weeks .

MRI will be used to compare tumor size at baseline and at 10 weeks. MRI will also be used to compare tumor size at baseline and after completion of 6 months of study medication or disease progression.

Outcome measures

Outcome measures
Measure	Phase 1 - Cohort A n=31 Participants Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer Anastrozole AZD0530	Phase 2 - Cohort B [Anastrozole + Placebo] n=19 Participants Dual treatment with 1 mg anastrozole orally once daily together with Placebo orally once daily, or as specified per protocol, until disease progression or4-6 months of treatment completed. Anastrozole Placebo
Phase II Cohort B: Change in Tumor Size by Comparison of Serial MRI MRI RECIST % change 10 weeks	-26.9 percentage of tumor volume change Standard Deviation 30.4	-15.9 percentage of tumor volume change Standard Deviation 19.6
Phase II Cohort B: Change in Tumor Size by Comparison of Serial MRI MRI tumor volume % change 10 weeks	-46.4 percentage of tumor volume change Standard Deviation 43.1	-35.0 percentage of tumor volume change Standard Deviation 31.7
Phase II Cohort B: Change in Tumor Size by Comparison of Serial MRI MRI RECIST % change 6 months	-44.6 percentage of tumor volume change Standard Deviation 34.1	-22.5 percentage of tumor volume change Standard Deviation 27.1
Phase II Cohort B: Change in Tumor Size by Comparison of Serial MRI MRI tumor volume % change 6 months	-70.7 percentage of tumor volume change Standard Deviation 29.5	-43.2 percentage of tumor volume change Standard Deviation 50.9

SECONDARY outcome

Timeframe: At completion of 4-6 cycles of therapy or after disease progression

A pathologic complete response will be defined as the absence of viable tumor cells in the resected specimen, as determined by standard histologic examination. All specimens will be reviewed by a central pathologist to determine pathologic response.

Outcome measures

Outcome measures
Measure	Phase 1 - Cohort A n=31 Participants Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer Anastrozole AZD0530	Phase 2 - Cohort B [Anastrozole + Placebo] n=19 Participants Dual treatment with 1 mg anastrozole orally once daily together with Placebo orally once daily, or as specified per protocol, until disease progression or4-6 months of treatment completed. Anastrozole Placebo
Phase II - Cohort B: Number of Participants With Pathologic Complete Response (pCR)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At the end of neoadjuvant therapy

Population: 8 patients were removed from the study due to adverse events

Based on physician measurement of tumor size and by MRI measurements of tumor volume using RECIST criteria

Outcome measures

Outcome measures
Measure	Phase 1 - Cohort A n=23 Participants Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer Anastrozole AZD0530	Phase 2 - Cohort B [Anastrozole + Placebo] n=19 Participants Dual treatment with 1 mg anastrozole orally once daily together with Placebo orally once daily, or as specified per protocol, until disease progression or4-6 months of treatment completed. Anastrozole Placebo
Phase II - Cohort B: The Number of Participants Achieving Clinical Benefit Defined as Complete Response (CR), or Partial Response (PR) or Stable Disease (SD) Complete Response	0 Participants	0 Participants
Phase II - Cohort B: The Number of Participants Achieving Clinical Benefit Defined as Complete Response (CR), or Partial Response (PR) or Stable Disease (SD) Partial Response	16 Participants	17 Participants
Phase II - Cohort B: The Number of Participants Achieving Clinical Benefit Defined as Complete Response (CR), or Partial Response (PR) or Stable Disease (SD) Stable Disease	0 Participants	0 Participants
Phase II - Cohort B: The Number of Participants Achieving Clinical Benefit Defined as Complete Response (CR), or Partial Response (PR) or Stable Disease (SD) Disease Progression	7 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 28, 56, 84

Population: PK assays of AZD0530 could not be completed for all participants due to technical problems with the assay protocol

Blood draws at protocol-specified timepoints to determine mean blood levels of drug for each of AZD0530 and Anastrozole.

Outcome measures

Outcome measures
Measure	Phase 1 - Cohort A n=39 Participants Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer Anastrozole AZD0530	Phase 2 - Cohort B [Anastrozole + Placebo] n=19 Participants Dual treatment with 1 mg anastrozole orally once daily together with Placebo orally once daily, or as specified per protocol, until disease progression or4-6 months of treatment completed. Anastrozole Placebo
Phase II - Cohort B: To Report the Pharmacokinetics (Mean Blood Levels of Drug) of AZD0530 (Saracatinib) and Anastrozole Anastrozole - Day 28	52.7 ng/ml Standard Deviation 22.3	37.4 ng/ml Standard Deviation 10.4
Phase II - Cohort B: To Report the Pharmacokinetics (Mean Blood Levels of Drug) of AZD0530 (Saracatinib) and Anastrozole Anastrozole - Day 56	49.9 ng/ml Standard Deviation 21	37.6 ng/ml Standard Deviation 12.3
Phase II - Cohort B: To Report the Pharmacokinetics (Mean Blood Levels of Drug) of AZD0530 (Saracatinib) and Anastrozole Anastrozole - Day 84	48.3 ng/ml Standard Deviation 17.2	39.5 ng/ml Standard Deviation 11.7
Phase II - Cohort B: To Report the Pharmacokinetics (Mean Blood Levels of Drug) of AZD0530 (Saracatinib) and Anastrozole AZD0530 - Day 28	264.6 ng/ml Standard Deviation 96.8	—
Phase II - Cohort B: To Report the Pharmacokinetics (Mean Blood Levels of Drug) of AZD0530 (Saracatinib) and Anastrozole AZD0530 - Day 56	286.4 ng/ml Standard Deviation 65.9	—
Phase II - Cohort B: To Report the Pharmacokinetics (Mean Blood Levels of Drug) of AZD0530 (Saracatinib) and Anastrozole AZD0530 - Day 84	258.6 ng/ml Standard Deviation 100.9	—

SECONDARY outcome

Timeframe: From day 1 of treatment until a maximum of 6 months of treatment

Cinically significant AEs defined as clinically significant changes in the patient's symptoms, physical examination and clinical laboratory results are reported as toxicity for AZD0530 (saracatinib) given with anastrozole and for anastrozole given with placebo

Outcome measures

Outcome measures
Measure	Phase 1 - Cohort A n=31 Participants Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer Anastrozole AZD0530	Phase 2 - Cohort B [Anastrozole + Placebo] n=19 Participants Dual treatment with 1 mg anastrozole orally once daily together with Placebo orally once daily, or as specified per protocol, until disease progression or4-6 months of treatment completed. Anastrozole Placebo
Phase II - Cohort B: Treatment Emergent Adverse Events Associated With AZD0530 (Saracatinib) Given With Anastrozole and of Anastrozole Given With Placebo Anemia	7 Participants	1 Participants
Phase II - Cohort B: Treatment Emergent Adverse Events Associated With AZD0530 (Saracatinib) Given With Anastrozole and of Anastrozole Given With Placebo Neutropenia	4 Participants	1 Participants
Phase II - Cohort B: Treatment Emergent Adverse Events Associated With AZD0530 (Saracatinib) Given With Anastrozole and of Anastrozole Given With Placebo Thrombocytopenia	3 Participants	0 Participants
Phase II - Cohort B: Treatment Emergent Adverse Events Associated With AZD0530 (Saracatinib) Given With Anastrozole and of Anastrozole Given With Placebo Fatigue	10 Participants	3 Participants
Phase II - Cohort B: Treatment Emergent Adverse Events Associated With AZD0530 (Saracatinib) Given With Anastrozole and of Anastrozole Given With Placebo Rash	24 Participants	3 Participants
Phase II - Cohort B: Treatment Emergent Adverse Events Associated With AZD0530 (Saracatinib) Given With Anastrozole and of Anastrozole Given With Placebo Alopecia	17 Participants	2 Participants
Phase II - Cohort B: Treatment Emergent Adverse Events Associated With AZD0530 (Saracatinib) Given With Anastrozole and of Anastrozole Given With Placebo Hot Flashes	18 Participants	7 Participants
Phase II - Cohort B: Treatment Emergent Adverse Events Associated With AZD0530 (Saracatinib) Given With Anastrozole and of Anastrozole Given With Placebo Anorexia	8 Participants	1 Participants
Phase II - Cohort B: Treatment Emergent Adverse Events Associated With AZD0530 (Saracatinib) Given With Anastrozole and of Anastrozole Given With Placebo Diarrhea	23 Participants	6 Participants
Phase II - Cohort B: Treatment Emergent Adverse Events Associated With AZD0530 (Saracatinib) Given With Anastrozole and of Anastrozole Given With Placebo Alanine aminotransferase increased	19 Participants	3 Participants
Phase II - Cohort B: Treatment Emergent Adverse Events Associated With AZD0530 (Saracatinib) Given With Anastrozole and of Anastrozole Given With Placebo Alkaline phosphatase increased	11 Participants	0 Participants
Phase II - Cohort B: Treatment Emergent Adverse Events Associated With AZD0530 (Saracatinib) Given With Anastrozole and of Anastrozole Given With Placebo Aspartate aminotransferase increased	20 Participants	1 Participants
Phase II - Cohort B: Treatment Emergent Adverse Events Associated With AZD0530 (Saracatinib) Given With Anastrozole and of Anastrozole Given With Placebo Creatinine increased	3 Participants	1 Participants
Phase II - Cohort B: Treatment Emergent Adverse Events Associated With AZD0530 (Saracatinib) Given With Anastrozole and of Anastrozole Given With Placebo Hyperbilirubinemia	3 Participants	0 Participants
Phase II - Cohort B: Treatment Emergent Adverse Events Associated With AZD0530 (Saracatinib) Given With Anastrozole and of Anastrozole Given With Placebo Flu-like syndrome	9 Participants	1 Participants
Phase II - Cohort B: Treatment Emergent Adverse Events Associated With AZD0530 (Saracatinib) Given With Anastrozole and of Anastrozole Given With Placebo Upper Respiratory Infection	14 Participants	2 Participants
Phase II - Cohort B: Treatment Emergent Adverse Events Associated With AZD0530 (Saracatinib) Given With Anastrozole and of Anastrozole Given With Placebo Urinary Tract Infection	13 Participants	1 Participants

Adverse Events

Phase 1 - Cohort A

Serious events: 3 serious events

Other events: 12 other events

Deaths: 2 deaths

Phase 2 - Cohort B [Anastrozole + AZD0530]

Serious events: 5 serious events

Other events: 39 other events

Deaths: 0 deaths

Phase 2 - Cohort B [Anastrozole + Placebo]

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1 - Cohort A n=12 participants at risk Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer Anastrozole AZD0530	Phase 2 - Cohort B [Anastrozole + AZD0530] n=39 participants at risk Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 175 mg orally once daily, or as specified per protocol, until disease progression or 4-6 months of treatment completed. Anastrozole AZD0530	Phase 2 - Cohort B [Anastrozole + Placebo] n=20 participants at risk Dual treatment with 1 mg anastrozole orally once daily together with Placebo orally once daily, or as specified per protocol, until disease progression or4-6 months of treatment completed. Anastrozole Placebo
Infections and infestations Urosepsis	16.7% 2/12 • Number of events 2 • 8 months. Adverse event data were collected from study entry until subjects were taken off therapy	0.00% 0/39 • 8 months. Adverse event data were collected from study entry until subjects were taken off therapy	0.00% 0/20 • 8 months. Adverse event data were collected from study entry until subjects were taken off therapy
Nervous system disorders Brain hemorrhage complicating CNS metastasis	8.3% 1/12 • Number of events 1 • 8 months. Adverse event data were collected from study entry until subjects were taken off therapy	0.00% 0/39 • 8 months. Adverse event data were collected from study entry until subjects were taken off therapy	0.00% 0/20 • 8 months. Adverse event data were collected from study entry until subjects were taken off therapy
Cardiac disorders Atrial fibrillation	0.00% 0/12 • 8 months. Adverse event data were collected from study entry until subjects were taken off therapy	2.6% 1/39 • Number of events 1 • 8 months. Adverse event data were collected from study entry until subjects were taken off therapy	0.00% 0/20 • 8 months. Adverse event data were collected from study entry until subjects were taken off therapy
Cardiac disorders Cardiac ischemia/infarction	0.00% 0/12 • 8 months. Adverse event data were collected from study entry until subjects were taken off therapy	2.6% 1/39 • Number of events 1 • 8 months. Adverse event data were collected from study entry until subjects were taken off therapy	0.00% 0/20 • 8 months. Adverse event data were collected from study entry until subjects were taken off therapy
Cardiac disorders Congestive Heart Failure	0.00% 0/12 • 8 months. Adverse event data were collected from study entry until subjects were taken off therapy	2.6% 1/39 • Number of events 1 • 8 months. Adverse event data were collected from study entry until subjects were taken off therapy	0.00% 0/20 • 8 months. Adverse event data were collected from study entry until subjects were taken off therapy
Skin and subcutaneous tissue disorders Rash	0.00% 0/12 • 8 months. Adverse event data were collected from study entry until subjects were taken off therapy	2.6% 1/39 • Number of events 1 • 8 months. Adverse event data were collected from study entry until subjects were taken off therapy	0.00% 0/20 • 8 months. Adverse event data were collected from study entry until subjects were taken off therapy
Gastrointestinal disorders Diverticulitis	0.00% 0/12 • 8 months. Adverse event data were collected from study entry until subjects were taken off therapy	2.6% 1/39 • Number of events 1 • 8 months. Adverse event data were collected from study entry until subjects were taken off therapy	0.00% 0/20 • 8 months. Adverse event data were collected from study entry until subjects were taken off therapy
Gastrointestinal disorders Cholecystitis	0.00% 0/12 • 8 months. Adverse event data were collected from study entry until subjects were taken off therapy	0.00% 0/39 • 8 months. Adverse event data were collected from study entry until subjects were taken off therapy	5.0% 1/20 • Number of events 1 • 8 months. Adverse event data were collected from study entry until subjects were taken off therapy
Hepatobiliary disorders Hyperbilirubinemia	0.00% 0/12 • 8 months. Adverse event data were collected from study entry until subjects were taken off therapy	2.6% 1/39 • Number of events 1 • 8 months. Adverse event data were collected from study entry until subjects were taken off therapy	0.00% 0/20 • 8 months. Adverse event data were collected from study entry until subjects were taken off therapy

Other adverse events

Additional Information

Joyce Slingerland MD PhD FCRP(C)

University of Miami

Phone: 305-243-7265

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place