Trial Outcomes & Findings for Exemestane and Cyclophosphamide for Metastatic Breast Cancer (NCT NCT01963481)

NCT ID: NCT01963481

Last Updated: 2020-03-17

Results Overview

PFS is defined as the time from first treatment day until objective disease progression or death from any cause. Assessment of disease progression based on Response Evaluation Criteria in Solid Tumor (RESIST) guideline version 1.1 is performed every 12 weeks on study. The percent of participants with PFS at 3 months will be reported.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

3 months

Results posted on

2020-03-17

Participant Flow

Participant milestones

Participant milestones
Measure	Exemestane and Cyclophosphamide A treatment cycle is defined as 4 weeks: One tablet (25 mg) of exemestane and one tablet (50 mg) of cyclophosphamide given daily by mouth until disease progression or unacceptable adverse events. Exemestane Cyclophosphamide
Overall Study STARTED	23
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Exemestane and Cyclophosphamide for Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exemestane and Cyclophosphamide n=23 Participants A treatment cycle is defined as 4 weeks: One tablet (25 mg) of exemestane and one tablet (50 mg) of cyclophosphamide given daily by mouth until disease progression or unacceptable adverse events. Exemestane Cyclophosphamide
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	23 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	0 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	23 Participants n=99 Participants
Region of Enrollment United States	23 Participants n=99 Participants

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	Exemestane and Cyclophosphamide n=23 Participants A treatment cycle is defined as 4 weeks: One tablet (25 mg) of exemestane and one tablet (50 mg) of cyclophosphamide given daily by mouth until disease progression or unacceptable adverse events. Exemestane Cyclophosphamide
Progression-free Survival (PFS) Rate at 3 Months	50.1 percent of participants Interval 33.0 to 76.0

SECONDARY outcome

Timeframe: 2 years

Complete response (CR) is defined as the disappearance of all target lesions, while partial response (PR) is when at least a 30% decrease in the sum of the diameters of target lesions. Evaluation of response is based on RESIST guideline version 1.1. RR is reported as percentage of participants with a CR and/or PR at 2 years.

Outcome measures

Outcome measures
Measure	Exemestane and Cyclophosphamide n=23 Participants A treatment cycle is defined as 4 weeks: One tablet (25 mg) of exemestane and one tablet (50 mg) of cyclophosphamide given daily by mouth until disease progression or unacceptable adverse events. Exemestane Cyclophosphamide
Response Rate (RR) - Complete Response and Partial Response	26.1 percent of participants Interval 10.2 to 48.4

SECONDARY outcome

Timeframe: 3 years

Clinical benefit rate is defined as the percentage of patients who have achieved objective response or stable disease for at least 24 weeks. Evaluation of response and disease progression is based on RESIST guideline version 1.1. Response and progression are assessed every 12 weeks.

Outcome measures

Outcome measures
Measure	Exemestane and Cyclophosphamide n=23 Participants A treatment cycle is defined as 4 weeks: One tablet (25 mg) of exemestane and one tablet (50 mg) of cyclophosphamide given daily by mouth until disease progression or unacceptable adverse events. Exemestane Cyclophosphamide
Clinical Benefit Rate Score	47.8 percent of participants Interval 26.8 to 69.4

Adverse Events

Exemestane and Cyclophosphamide

Serious events: 10 serious events

Other events: 0 other events

Deaths: 10 deaths

Serious adverse events

Serious adverse events
Measure	Exemestane and Cyclophosphamide n=23 participants at risk A treatment cycle is defined as 4 weeks: One tablet (25 mg) of exemestane and one tablet (50 mg) of cyclophosphamide given daily by mouth until disease progression or unacceptable adverse events. Exemestane Cyclophosphamide
Respiratory, thoracic and mediastinal disorders pulmonary embolism	43.5% 10/23 • Number of events 23 • 13.7 Months

Other adverse events

Adverse event data not reported

Additional Information

Sylvia Adams

NYU Langone Health

Phone: 212 731 5795

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place