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Trial record 6 of 164 for:    PEMT

Intermittent Letrozole Therapy in Postmenopausal Women With Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00549822
Recruitment Status : Terminated (Slow Accrual)
First Posted : October 26, 2007
Results First Posted : March 22, 2017
Last Update Posted : March 22, 2017
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Novartis
Information provided by (Responsible Party):
Paul Goss, MD, PhD, Massachusetts General Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Intervention Drug: Letrozole
Enrollment 3
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Intermittent Letrozole Therapy
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 3
Completed 3
Not Completed 0
Arm/Group Title Intermittent Letrozole Therapy
Hide Arm/Group Description

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 Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
  33.3%
>=65 years
2
  66.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
3
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
3
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
3
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Number of Patients With Decline in Serum CA 15-3 (Carcinoma Antigen 15-3)
Hide Description 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.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intermittent Letrozole Therapy
Hide Arm/Group Description:

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 Number of Participants Analyzed 3
Measure Type: Count of Participants
Unit of Measure: Participants
3
 100.0%
2.Secondary Outcome
Title Median Time to Disease Progression With Intermittent Letrozole.
Hide Description The median time to disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors).
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intermittent Letrozole Therapy
Hide Arm/Group Description:

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 Number of Participants Analyzed 3
Median (Full Range)
Unit of Measure: Months
47 [1] 
(28.5 to NA)
[1]
Third participant did not have progressive disease during study follow-up.
3.Secondary Outcome
Title Serum HER-2/Neu Levels and Serum/Plasma Angiogenic Mediators
Hide Description Measurements for the serum HER-2/neu (human epidermal growth factor receptor 2) levels and serum/plasma angiogenic mediators
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated prematurely due to slow accrual. Outcome measure data not available for analysis.
Arm/Group Title Intermittent Letrozole Therapy
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Duration of treatment and twelve weeks after stopping treatment.
Adverse Event Reporting Description 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.
 
Arm/Group Title Intermittent Letrozole Therapy
Hide Arm/Group Description Letrozole 2.5mg: Intermittently
All-Cause Mortality
Intermittent Letrozole Therapy
Affected / at Risk (%)
Total   2/3 (66.67%)    
Show Serious Adverse Events Hide Serious Adverse Events
Intermittent Letrozole Therapy
Affected / at Risk (%) # Events
Total   0/3 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intermittent Letrozole Therapy
Affected / at Risk (%) # Events
Total   3/3 (100.00%)    
Blood and lymphatic system disorders   
Hemoglobin  1  2/3 (66.67%)  24
Lymphopenia  1  1/3 (33.33%)  12
Hemorrhage-other  1  1/3 (33.33%)  13
Endocrine disorders   
Hot flashes  1  3/3 (100.00%)  54
Gastrointestinal disorders   
Constipation  1  3/3 (100.00%)  54
Gastritis  1  1/3 (33.33%)  2
Nausea  1  3/3 (100.00%)  54
General disorders   
Fatigue  1  3/3 (100.00%)  54
Weight loss  1  1/3 (33.33%)  1
Head/headache  1  1/3 (33.33%)  1
Pain-other  1  2/3 (66.67%)  3
Infections and infestations   
Infection Gr0-2 neut, sinus  1  1/3 (33.33%)  1
Metabolism and nutrition disorders   
Alkaline phosphatase  1  1/3 (33.33%)  5
ALT, SGPT  1  1/3 (33.33%)  6
AST, SGOT  1  1/3 (33.33%)  6
Creatinine  1  1/3 (33.33%)  5
Hyperglycemia  1  2/3 (66.67%)  14
Hyponatremia  1  1/3 (33.33%)  3
Metabolic/Laboratory-other  1  2/3 (66.67%)  11
Musculoskeletal and connective tissue disorders   
Back, pain  1  3/3 (100.00%)  53
Bone, pain  1  3/3 (100.00%)  54
Chest wall, pain  1  2/3 (66.67%)  2
Extremity-limb, pain  1  1/3 (33.33%)  3
Joint, pain  1  3/3 (100.00%)  54
Renal and urinary disorders   
Renal/GU-other  1  1/3 (33.33%)  14
Respiratory, thoracic and mediastinal disorders   
Cough  1  3/3 (100.00%)  54
Dyspnea  1  3/3 (100.00%)  54
Skin and subcutaneous tissue disorders   
Alopecia  1  1/3 (33.33%)  1
Rash: acne/acneiform  1  1/3 (33.33%)  1
Skin-other  1  1/3 (33.33%)  2
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
The study closed prematurely before the planned enrollment of 20 patients due to poor patient accrual. The patient population was highly selected, were likely to have had disease with an indolent natural history.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Paul Goss
Organization: Massachusetts General Hospital
Phone: 617-724-3118
Responsible Party: Paul Goss, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00549822     History of Changes
Other Study ID Numbers: 07-109
First Submitted: October 24, 2007
First Posted: October 26, 2007
Results First Submitted: October 26, 2016
Results First Posted: March 22, 2017
Last Update Posted: March 22, 2017