Trial Outcomes & Findings for Comparing Letrozole Given Alone to Letrozole Given With Avastin in Post-Menopausal Women Breast Cancer (NCT NCT00530868)

Last Updated: 2022-10-21

Results Overview

Pathological complete response is defined as the absence of residual invasive tumor in the breast or axillary lymph nodes or if only residual ductal carcinoma in-situ was seen on review of the surgical specimen.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

75 participants

Primary outcome timeframe

24 weeks

Results posted on

2022-10-21

Participant Flow

Participant milestones

Participant milestones
Measure	Letrozole + Avastin Letrozole; Avastin: Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks	Letrozole Alone Letrozole (Femara): Letrozole 2.5 mg PO a day for 24 weeks
Overall Study STARTED	50	25
Overall Study COMPLETED	50	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparing Letrozole Given Alone to Letrozole Given With Avastin in Post-Menopausal Women Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Letrozole + Avastin n=50 Participants Letrozole; Avastin: Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks	Letrozole Alone n=25 Participants Letrozole (Femara): Letrozole 2.5 mg PO a day for 24 weeks	Total n=75 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=93 Participants	25 Participants n=4 Participants	75 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	58 years STANDARD_DEVIATION 0.5 • n=93 Participants	58 years STANDARD_DEVIATION 0.5 • n=4 Participants	58 years STANDARD_DEVIATION 0.5 • n=27 Participants
Sex: Female, Male Female	50 Participants n=93 Participants	25 Participants n=4 Participants	75 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	7 Participants n=93 Participants	3 Participants n=4 Participants	10 Participants n=27 Participants
Race (NIH/OMB) White	40 Participants n=93 Participants	20 Participants n=4 Participants	60 Participants n=27 Participants
Race (NIH/OMB) More than one race	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment United States	50 Participants n=93 Participants	25 Participants n=4 Participants	75 Participants n=27 Participants
Study Participant	50 Participants n=93 Participants	25 Participants n=4 Participants	75 Participants n=27 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Patients with postmenopausal hormone receptor positive breast cancer T2-4,N0-2 and M0 were randomized 2:1 to receive letrozole 2.5 mg PO daily and bevacizumab 15 mg/kg IV for 24 weeks or daily treatment with letrozole 2.5 mg PO alone (control arm). The duration of each cycle was 3 weeks for a total of 24 weeks. The pCR was defined as the absence of any residual invasive cancer in the resected breast specimen and lymph nodes. Data below is representative of the raw data.

Outcome measures

Outcome measures
Measure	Letrozole + Avastin n=50 Participants Letrozole; Avastin: Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks	Letrozole Alone n=25 Participants Letrozole (Femara): Letrozole 2.5 mg PO a day for 24 weeks
The Percentage of Participants With Pathologic Complete Response	11 percentage of participants Interval 3.7 to 24.1	0 percentage of participants Interval 0.0 to 14.2

SECONDARY outcome

Timeframe: 24 weeks

Population: This was a single arm study to test the feasibility of Letrozole with Avastin in the neoadjuvant setting.

Radiographic objective response to the therapy are reported. Radiographic response was assessed using RECIST criteria by ultrasound or breast MRI through the study and are reported as complete radiographic response below.

Outcome measures

Outcome measures
Measure	Letrozole + Avastin n=50 Participants Letrozole; Avastin: Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks	Letrozole Alone n=25 Participants Letrozole (Femara): Letrozole 2.5 mg PO a day for 24 weeks
Letrozole +Avastin	10 participants Interval 3.4 to 22.0	4 participants Interval 0.0 to 20.4

Adverse Events

Letrozole + Avastin

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Letrozole Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Letrozole + Avastin n=50 participants at risk Letrozole; Avastin: Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks. Adverse events typically associated with letrozole (hot flashes, arthralgias, fatigue, myalgias) occurred in similar frequencies in the two arms. Hypertension, headache, and proteinuria were seen exclusively in the Let/Bev arm.	Letrozole Alone n=25 participants at risk Letrozole (Femara): Letrozole 2.5 mg PO a day for 24 weeks Adverse events typically associated with letrozole (hot flashes, arthralgias, fatigue, myalgias) occurred in similar frequencies in the two arms. Hypertension, headache, and proteinuria were seen exclusively in the Let/Bev arm.
Renal and urinary disorders Proteinuria	4.0% 2/50 • 24 weeks of active treatment	0.00% 0/25 • 24 weeks of active treatment

Other adverse events

Other adverse events
Measure	Letrozole + Avastin n=50 participants at risk Letrozole; Avastin: Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks. Adverse events typically associated with letrozole (hot flashes, arthralgias, fatigue, myalgias) occurred in similar frequencies in the two arms. Hypertension, headache, and proteinuria were seen exclusively in the Let/Bev arm.	Letrozole Alone n=25 participants at risk Letrozole (Femara): Letrozole 2.5 mg PO a day for 24 weeks Adverse events typically associated with letrozole (hot flashes, arthralgias, fatigue, myalgias) occurred in similar frequencies in the two arms. Hypertension, headache, and proteinuria were seen exclusively in the Let/Bev arm.
Nervous system disorders Headache	4.0% 2/50 • Number of events 4 • 24 weeks of active treatment	0.00% 0/25 • 24 weeks of active treatment

Additional Information

Lisle Nabell

UAB

Phone: 205 934-3061

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place