Trial Outcomes & Findings for Letrozole and Imatinib Mesylate in Treating Postmenopausal Participants With Estrogen or Progesterone Positive Metastatic Breast Cancer (NCT NCT00338728)

Last Updated: 2020-01-27

Results Overview

Among participants with CR or PR as the best overall response, duration of response (DOR) was defined as the time from which measurement criteria were met for CR or PR until the date of progression. Progression-free survival (PFS) was defined as the time from study enrollment to disease progression or death from any cause, whichever occurred first. PFS data were censored at the time of removal from study. Overall survival (OS) was defined as the time from study registration to death from any cause. Information on vital status was collected following study completion through July 23, 2018 and was used in the determination of OS. Among patients with SD as the best overall response, duration of SD was defined as the time from study enrollment to disease progression or removal from study.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

59 participants

Primary outcome timeframe

From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months

Results posted on

2020-01-27

Participant Flow

Participants were recruited from November 2003 to October 2008. The participating subjects must sign the consent document pertaining to the study and meet all the eligibility criteria as mentioned in the protocol, before initiating on the study treatment.

The study start date is the activation date which is October 2, 2003, but the first patient consented was on November 3, 2003.

Participant milestones

Participant milestones
Measure	Letrozole and Imatinib Mesylate Imatinib mesylate 400 mg by mouth twice a day daily for 28 days and Letrozole 2.5 mg once a day daily for 28 days cycle.
Overall Study STARTED	59
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Letrozole and Imatinib Mesylate Imatinib mesylate 400 mg by mouth twice a day daily for 28 days and Letrozole 2.5 mg once a day daily for 28 days cycle.
Overall Study Screen Failure	14

Baseline Characteristics

Letrozole and Imatinib Mesylate in Treating Postmenopausal Participants With Estrogen or Progesterone Positive Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Letrozole and Imatinib Mesylate n=45 Participants Imatinib mesylate 400 mg by mouth twice a day daily for 28 days and Letrozole 2.5 mg once a day daily for 28 days cycle.
Age, Continuous	62.4 years n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	45 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months

Population: Five participants was non evaluable due participants did not complete the first 2 cycles. (8 weeks)

Outcome measures

Outcome measures
Measure	Letrozole and Imatinib Mesylate n=45 Participants Imatinib mesylate 400 mg by mouth twice a day daily for 28 days and Letrozole 2.5 mg once a day daily for 28 days cycle.
Objective Response Rate (ORR) Progressive Disease	11 Participants
Objective Response Rate (ORR) Complete Response (CR)	0 Participants
Objective Response Rate (ORR) Partial Response (PR)	5 Participants
Objective Response Rate (ORR) SD (including non-CR/Non-PD)>/=24 weeks	16 Participants
Objective Response Rate (ORR) SD (including non-CR/Non-PD)</=24 weeks	8 Participants
Objective Response Rate (ORR) Non-Evaluable	5 Participants

PRIMARY outcome

Timeframe: From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months

This sample size would provide an estimate of the objective response rate (ORR) 95% confidence intervals for the ORR and CBR were calculated using the exact binomial method. Among patients with CR or PR as the best overall response, duration of response (DOR) was defined as the time from which measurement criteria were met for CR or PR until the date of progression. Progression-free survival (PFS) was defined as the time from study enrollment to disease progression or death from any cause, whichever occurred first. PFS data were censored at the time of removal from study. Overall survival (OS) was defined as the time from study registration to death from any cause. Information on vital status was collected following study completion through July 23, 2018 and was used in the determination of OS. Among patients with SD as the best overall response, duration of SD was defined as the time from study enrollment to disease progression or removal from study.

Outcome measures

Outcome measures
Measure	Letrozole and Imatinib Mesylate n=45 Participants Imatinib mesylate 400 mg by mouth twice a day daily for 28 days and Letrozole 2.5 mg once a day daily for 28 days cycle.
Overall Survival of Participants Progression-free survival (PFS)	8.7 months Interval 3.8 to 11.4
Overall Survival of Participants Overall Survival (OS)	44.3 months Interval 34.0 to 55.3

Adverse Events

Letrozole and Imatinib Mesylate

Serious events: 14 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Letrozole and Imatinib Mesylate n=45 participants at risk Imatinib mesylate 400 mg by mouth twice a day daily for 28 days and Letrozole 2.5 mg once a day daily for 28 days cycle.
Gastrointestinal disorders Diarrhea	15.6% 7/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
General disorders Fatigue	6.7% 3/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Blood and lymphatic system disorders Neutropenia	4.4% 2/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Musculoskeletal and connective tissue disorders Myalgia	2.2% 1/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Investigations Elevated bilirubin	2.2% 1/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months

Other adverse events

Other adverse events
Measure	Letrozole and Imatinib Mesylate n=45 participants at risk Imatinib mesylate 400 mg by mouth twice a day daily for 28 days and Letrozole 2.5 mg once a day daily for 28 days cycle.
Gastrointestinal disorders Nausea	42.2% 19/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Gastrointestinal disorders Vomitting	37.8% 17/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Gastrointestinal disorders Heartburn	13.3% 6/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Gastrointestinal disorders Diarrhea (grade 2)	22.2% 10/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Gastrointestinal disorders Constipation	8.9% 4/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Gastrointestinal disorders Abdominal pain	4.4% 2/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Gastrointestinal disorders Rectal bleeding	2.2% 1/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Investigations Edema	22.2% 10/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 5/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Musculoskeletal and connective tissue disorders Myalgia	22.2% 10/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Nervous system disorders Headache (grade 2)	2.2% 1/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Nervous system disorders Pain	6.7% 3/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Blood and lymphatic system disorders Neutropenia	13.3% 6/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Blood and lymphatic system disorders Leukopenia (grade2)	8.9% 4/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Blood and lymphatic system disorders Anemia	24.4% 11/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Investigations Infection	6.7% 3/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
General disorders Fatigue	51.1% 23/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Investigations ALT elevation	4.4% 2/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Investigations AST elevation	6.7% 3/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Investigations ALP elevation	4.4% 2/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Investigations Stomatitis (grade 2)	2.2% 1/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Skin and subcutaneous tissue disorders Erythema multiforme	6.7% 3/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Skin and subcutaneous tissue disorders Rash (grade 2)	2.2% 1/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Skin and subcutaneous tissue disorders Pruritis	13.3% 6/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.7% 3/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Respiratory, thoracic and mediastinal disorders Dyspnea	4.4% 2/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Metabolism and nutrition disorders Hypopigmentation (grade 2)	4.4% 2/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Metabolism and nutrition disorders Hypokalemia	4.4% 2/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Nervous system disorders Sensory neuropathy (grade 2)	4.4% 2/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Investigations Alopecia (grade 2)	2.2% 1/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months
Reproductive system and breast disorders Hot flashes (grade 2)	6.7% 3/45 • From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months

Additional Information

Dr. Arun,Banu,M.D. / Breast Medical Oncology

UT MD Anderson Cancer Center

Phone: 713-792-2817

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place