Trial Outcomes & Findings for Intermittent Letrozole Therapy in Postmenopausal Women With Metastatic Breast Cancer (NCT NCT00549822)

Last Updated: 2017-03-22

Results Overview

The Number of patients that have have a response of a decrease in CA 15-3 or CA 27.29 levels by at least 50% of that individual patient's baseline or peak level after re-introducing Letrozole therapy following a break in therapy as described in the intervention.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

3 years

Results posted on

2017-03-22

Participant Flow

Postmenopausal patients with ER-positive (ER+) metastatic breast cancer (MBC) that were enrolled on an institutional review board (IRB) approved, phase II, multicenter clinical trial protocol (NCT00549822) evaluating intermittent AI (Aromatase Inhibitor) therapy. The study opened to accrual August 29, 2006 and closed to accrual on May 17, 2010.

Participant milestones

Participant milestones
Measure	Intermittent Letrozole Therapy Letrozole 2.5mg: Intermittently Letrozole 2.5 mg administered by mouth each day during each 28 day treatment cycle. Treatment is intermittent with possible breaks between each 28 day treatment cycle. Letrozole is administered until the participant has disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors), experiences severe side effects, or decides to stop treatment.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intermittent Letrozole Therapy in Postmenopausal Women With Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intermittent Letrozole Therapy n=3 Participants Letrozole 2.5mg: Intermittently Letrozole 2.5 mg administered by mouth each day during each 28 day treatment cycle. Treatment is intermittent with possible breaks between each 28 day treatment cycle. Letrozole is administered until the participant has disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors), experiences severe side effects, or decides to stop treatment.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Outcome measures

Outcome measures
Measure	Intermittent Letrozole Therapy n=3 Participants Letrozole 2.5mg: Intermittently Letrozole 2.5 mg administered by mouth each day during each 28 day treatment cycle. Treatment is intermittent with possible breaks between each 28 day treatment cycle. Letrozole is administered until the participant has disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors), experiences severe side effects, or decides to stop treatment.
Number of Patients With Decline in Serum CA 15-3 (Carcinoma Antigen 15-3)	3 Participants

SECONDARY outcome

Timeframe: 3 years

The median time to disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors).

Outcome measures

Outcome measures
Measure	Intermittent Letrozole Therapy n=3 Participants Letrozole 2.5mg: Intermittently Letrozole 2.5 mg administered by mouth each day during each 28 day treatment cycle. Treatment is intermittent with possible breaks between each 28 day treatment cycle. Letrozole is administered until the participant has disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors), experiences severe side effects, or decides to stop treatment.
Median Time to Disease Progression With Intermittent Letrozole.	47 Months Interval 28.5 to Third participant did not have progressive disease during study follow-up.

SECONDARY outcome

Timeframe: 2 years

Population: Study terminated prematurely due to slow accrual. Outcome measure data not available for analysis.

Measurements for the serum HER-2/neu (human epidermal growth factor receptor 2) levels and serum/plasma angiogenic mediators

Outcome measures

Outcome data not reported

Adverse Events

Intermittent Letrozole Therapy

Serious events: 0 serious events

Other events: 3 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intermittent Letrozole Therapy n=3 participants at risk Letrozole 2.5mg: Intermittently
Blood and lymphatic system disorders Hemoglobin	66.7% 2/3 • Number of events 24 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
Blood and lymphatic system disorders Lymphopenia	33.3% 1/3 • Number of events 12 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
General disorders Fatigue	100.0% 3/3 • Number of events 54 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
General disorders Weight loss	33.3% 1/3 • Number of events 1 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
Skin and subcutaneous tissue disorders Alopecia	33.3% 1/3 • Number of events 1 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	33.3% 1/3 • Number of events 1 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
Skin and subcutaneous tissue disorders Skin-other	33.3% 1/3 • Number of events 2 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
Endocrine disorders Hot flashes	100.0% 3/3 • Number of events 54 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
Gastrointestinal disorders Constipation	100.0% 3/3 • Number of events 54 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
Gastrointestinal disorders Gastritis	33.3% 1/3 • Number of events 2 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
Gastrointestinal disorders Nausea	100.0% 3/3 • Number of events 54 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
Blood and lymphatic system disorders Hemorrhage-other	33.3% 1/3 • Number of events 13 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
Infections and infestations Infection Gr0-2 neut, sinus	33.3% 1/3 • Number of events 1 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
Metabolism and nutrition disorders Alkaline phosphatase	33.3% 1/3 • Number of events 5 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
Metabolism and nutrition disorders ALT, SGPT	33.3% 1/3 • Number of events 6 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
Metabolism and nutrition disorders AST, SGOT	33.3% 1/3 • Number of events 6 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
Metabolism and nutrition disorders Creatinine	33.3% 1/3 • Number of events 5 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
Metabolism and nutrition disorders Hyperglycemia	66.7% 2/3 • Number of events 14 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
Metabolism and nutrition disorders Hyponatremia	33.3% 1/3 • Number of events 3 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
Metabolism and nutrition disorders Metabolic/Laboratory-other	66.7% 2/3 • Number of events 11 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
Musculoskeletal and connective tissue disorders Back, pain	100.0% 3/3 • Number of events 53 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
Musculoskeletal and connective tissue disorders Bone, pain	100.0% 3/3 • Number of events 54 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
Musculoskeletal and connective tissue disorders Chest wall, pain	66.7% 2/3 • Number of events 2 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
Musculoskeletal and connective tissue disorders Extremity-limb, pain	33.3% 1/3 • Number of events 3 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
General disorders Head/headache	33.3% 1/3 • Number of events 1 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
Musculoskeletal and connective tissue disorders Joint, pain	100.0% 3/3 • Number of events 54 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
General disorders Pain-other	66.7% 2/3 • Number of events 3 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
Respiratory, thoracic and mediastinal disorders Cough	100.0% 3/3 • Number of events 54 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
Respiratory, thoracic and mediastinal disorders Dyspnea	100.0% 3/3 • Number of events 54 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.
Renal and urinary disorders Renal/GU-other	33.3% 1/3 • Number of events 14 • Duration of treatment and twelve weeks after stopping treatment. Adverse events are recorded when reported by subjects and systematically evaluated through laboratory tests, physicals, and physician interviews every four weeks for the duration of treatment. Patients are followed for 12 weeks after removal from study or until death, whichever occurs first.

Additional Information

Dr. Paul Goss

Massachusetts General Hospital

Phone: 617-724-3118

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place