Trial Outcomes & Findings for Anastrozole and ZD1839 Compared With Fulvestrant and ZD1839 in Postmenopausal Women w/ Metastatic Breast Cancer (NCT NCT00057941)

Last Updated: 2014-05-12

Results Overview

Clinical benefit = complete response (CR), partial response (PR), or stable disease (SD) lasting for at least 6 months, assessed per Response Evaluation Criteria of Solid Tumor (RECIST).CR=disappearance of all target and non-target lesions. PR= disappearance of or at least 30% decrease in the sum of the longest diameters of target lesions, with non-progressive disease in non-target lesions. SD= sum of the longest diameters of target lesions decrease \<30% or increase \<20%, with non-progressive disease in non-target lesions. 141 eligible, treated patients were included.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

148 participants

Primary outcome timeframe

assessed every 3 cycles while on treatment, assessed every 3 months when follow up <2 years, every 6 months between 2-3 years,no specific requirements after 3 years

Results posted on

2014-05-12

Participant Flow

The study opened on September 16, 2003 and closed on May 29, 2007, with final accrual of 148 patients, 74 on each arm. Patients were accrued through ECOG group.

Participant milestones

Participant milestones
Measure	Arm I (Anastrozole and ZD1839) Patients receive oral anastrozole and oral gefitinib once daily on days 1-28.	Arm II (Fulvestrant and ZD1839) Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28.
Overall Study STARTED	74	74
Overall Study Treated	74	74
Overall Study Eligible	72	69
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	74	74

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Anastrozole and ZD1839) Patients receive oral anastrozole and oral gefitinib once daily on days 1-28.	Arm II (Fulvestrant and ZD1839) Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28.
Overall Study Death	1	2
Overall Study Adverse Event	7	9
Overall Study Lack of Efficacy	54	53
Overall Study Withdrawal by Subject	6	1
Overall Study still on treatment	3	1
Overall Study insurance, symptomatic deterioration	1	3
Overall Study Ineligible	2	5

Baseline Characteristics

Anastrozole and ZD1839 Compared With Fulvestrant and ZD1839 in Postmenopausal Women w/ Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Anastrozole and ZD1839) n=72 Participants Patients receive oral anastrozole and oral gefitinib once daily on days 1-28.	Arm II (Fulvestrant and ZD1839) n=69 Participants Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28.	Total n=141 Participants Total of all reporting groups
Age, Continuous	58 years n=99 Participants	63 years n=107 Participants	59 years n=206 Participants
Sex: Female, Male Female	72 Participants n=99 Participants	69 Participants n=107 Participants	141 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	39 participants n=99 Participants	39 participants n=107 Participants	78 participants n=206 Participants
Region of Enrollment Peru	33 participants n=99 Participants	29 participants n=107 Participants	62 participants n=206 Participants
Region of Enrollment South Africa	0 participants n=99 Participants	1 participants n=107 Participants	1 participants n=206 Participants

PRIMARY outcome

Timeframe: assessed every 3 cycles while on treatment, assessed every 3 months when follow up <2 years, every 6 months between 2-3 years,no specific requirements after 3 years

Population: 141 eligible and treated patients, 72 on Arm I (Anastrozole and ZD1839) and 69 on Arm II (Fulvestrant and ZD1839)

Outcome measures

Outcome measures
Measure	Anastrozole and ZD1839 n=72 Participants	Fulvestrant and ZD1839 n=69 Participants
Clinical Benefit Rate	44 percentage of participants Interval 33.0 to 57.0	41 percentage of participants Interval 29.0 to 53.0

Adverse Events

Arm I (Anastrozole and ZD1839)

Serious events: 27 serious events

Other events: 72 other events

Deaths: 0 deaths

Arm II (Fulvestrant and ZD1839)

Serious events: 28 serious events

Other events: 70 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Study Statistician

Eastern Cooperative Oncology Group (ECOG) Statistical Office

Phone: 617-632-3012

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Arm I (Anastrozole and ZD1839) n=74 participants at risk Patients receive oral anastrozole and oral gefitinib once daily on days 1-28.	Arm II (Fulvestrant and ZD1839) n=74 participants at risk Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28.
Blood and lymphatic system disorders Anemia	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Investigations Neutropenia	0.00% 0/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Cardiac disorders Sinus bradycardia	0.00% 0/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Vascular disorders Hypertension	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	0.00% 0/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Vascular disorders Thrombosis/Embolism	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
General disorders Fatigue	2.7% 2/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	2.7% 2/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Investigations Weight loss	0.00% 0/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Investigations Elevated Partial thromboplastin time (PTT)	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	0.00% 0/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Investigations Elevated Prothrombin Time (PT)	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	0.00% 0/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Skin and subcutaneous tissue disorders Hand-foot reaction	2.7% 2/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	0.00% 0/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Skin and subcutaneous tissue disorders Rash/desquamation	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Skin and subcutaneous tissue disorders Skin-other	0.00% 0/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Metabolism and nutrition disorders Anorexia	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	4.1% 3/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Metabolism and nutrition disorders Dehydration	2.7% 2/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	2.7% 2/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Gastrointestinal disorders Dyspepsia	0.00% 0/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Gastrointestinal disorders Dysphagia	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	0.00% 0/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Gastrointestinal disorders Gastritis	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	0.00% 0/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Gastrointestinal disorders Nausea	4.1% 3/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	4.1% 3/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Gastrointestinal disorders Vomiting	2.7% 2/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	2.7% 2/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Gastrointestinal disorders Diarrhea w/o prior colostomy	5.4% 4/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	13.5% 10/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Metabolism and nutrition disorders Bilirubin increased	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	2.7% 2/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Hepatobiliary disorders AST increased	6.8% 5/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	8.1% 6/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Hepatobiliary disorders ALT increased	4.1% 3/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	4.1% 3/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Infections and infestations Infection w/o neutropenia	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	4.1% 3/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Infections and infestations Lymphatics-other	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	0.00% 0/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Musculoskeletal and connective tissue disorders Joint,muscle, bone-other	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	0.00% 0/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Nervous system disorders Syncope	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	0.00% 0/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Musculoskeletal and connective tissue disorders Tearing	0.00% 0/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Musculoskeletal and connective tissue disorders Arthralgia	6.8% 5/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	0.00% 0/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Nervous system disorders Headache	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	0.00% 0/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Musculoskeletal and connective tissue disorders Myalgia	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	0.00% 0/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Reproductive system and breast disorders Pelvic pain	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	0.00% 0/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome (ARDS)	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Respiratory, thoracic and mediastinal disorders Dyspnea	2.7% 2/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	2.7% 2/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Investigations Creatinine increased	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Renal and urinary disorders Dysuria	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	0.00% 0/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Renal and urinary disorders Renal failure	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	0.00% 0/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Renal and urinary disorders Ureteral obstruction	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	0.00% 0/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment
Reproductive system and breast disorders Vaginitis	1.4% 1/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment	0.00% 0/74 • Assessed each cycle (4 weeks) while on treatment and for 30 days after the end of treatment