Trial Outcomes & Findings for Preoperative Window of Endocrine Therapy Provides Information to Increase Compliance (NCT NCT01614210)

NCT ID: NCT01614210

Last Updated: 2018-08-01

Results Overview

Demonstrate a significant change in Ki67 expression in tumors with 7 days of pre-surgical tamoxifen.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 52 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2018-08-01

Participant Flow

Participant milestones

Measure	Tamoxifen Pre and Post Breast Surgery All patients enrolled in the study. Tamoxifen: All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery. Breast cancer surgery: Breast cancer surgery
Overall Study STARTED	52
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preoperative Window of Endocrine Therapy Provides Information to Increase Compliance

Baseline characteristics by cohort

Measure	Tamoxifen Pre and Post Breast Surgery n=52 Participants All patients enrolled in the study. Tamoxifen: All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery. Breast cancer surgery: Breast cancer surgery
Age, Continuous	58.5 years n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	52 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days

Population: 3 were not evaluable due to rescheduling of surgery; 1 not evaluable due to pharmacy error. 2 patients had no invasive tumor on Ki-67 slides from pretreatment biopsy, and 2 patients had no invasive tumor on post-treatment surgery and were not evaluable.

Demonstrate a significant change in Ki67 expression in tumors with 7 days of pre-surgical tamoxifen.

Outcome measures

Measure	Tamoxifen Pre and Post Breast Surgery n=44 Participants All patients enrolled in the study. Tamoxifen: All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery. Breast cancer surgery: Breast cancer surgery
Change in Ki67 Expression in Tumors	-40 percentage change in Ki67 Interval -63.0 to -29.0

SECONDARY outcome

Timeframe: 18 months

Population: Of the 44 patients evaluable for the primary outcome measure, 35 completed both baseline and 18 month FACT-ES assessments

Patients were given the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) quality of life assessment at baseline (prior to tamoxifen administration) and again 18 months following breast surgery to assess quality of life. The difference in total score from baseline to 18 months was calculated. The FACT-ES total score ranges from 0-180, with higher scores indicating higher quality of life.

Outcome measures

Measure	Tamoxifen Pre and Post Breast Surgery n=35 Participants All patients enrolled in the study. Tamoxifen: All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery. Breast cancer surgery: Breast cancer surgery
Change in FACT-ES Symptom Scores	-4.53 change in units on a scale Interval -9.68 to 0.62

SECONDARY outcome

Timeframe: 18 months

Population: Of the 52 patients enrolled on the study, 38 patients had data regarding long term endocrine therapy at 18 months post-surgery.

For the patient population on this study, endocrine therapy was indicated for 5 years post-surgery according to the current standard of care recommendations for hormone positive breast cancer. Endocrine therapy was prescribed as standard of care as appropriate for each patient's situation. At 18 months post-surgery, patients were evaluated to determine if they were taking their endocrine therapy as prescribed.

Outcome measures

Measure	Tamoxifen Pre and Post Breast Surgery n=38 Participants All patients enrolled in the study. Tamoxifen: All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery. Breast cancer surgery: Breast cancer surgery
Number of Participants With Long Term Endocrine Therapy Adherence	33 participants adhering to therapy

SECONDARY outcome

Timeframe: 7 days

Population: Of the 50 patients enrolled Ki67 measurements were obtained for 44. Of the 44 patients which had a Ki67 result, 43 had both a pre and post symptom score.

Evaluate correlation between changes in Ki67 expression and symptom scores. Differences between changes in FACT-ES total score were correlated with changes in Ki67 expression using a the Spearman correlation method and results are expressed as the correlation coefficient.

Outcome measures

Measure	Tamoxifen Pre and Post Breast Surgery n=43 Participants All patients enrolled in the study. Tamoxifen: All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery. Breast cancer surgery: Breast cancer surgery
Correlation Between Changes in Ki67 and Symptoms	-0.02 spearman correlation coefficient

OTHER_PRE_SPECIFIED outcome

Timeframe: 7 days

Population: Of the 50 patients enrolled, 46 had both pre and post FACT-ES total scores.

Patients were given the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) quality of life assessment at baseline (prior to tamoxifen administration) and again 7 days following start of tamoxifen to assess quality of life while on tamoxifen. The difference in total score from baseline to 7 days was calculated. The FACT-ES total score ranges from 0-180, with higher scores indicating higher quality of life.

Outcome measures

Measure	Tamoxifen Pre and Post Breast Surgery n=46 Participants All patients enrolled in the study. Tamoxifen: All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery. Breast cancer surgery: Breast cancer surgery
Change in FACT-ES Symptom Scores	1.5 change in units on a scale Interval -54.0 to 21.0

Adverse Events

Tamoxifen Pre and Post Breast Surgery

Serious events: 1 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tamoxifen Pre and Post Breast Surgery n=52 participants at risk All patients enrolled in the study. Tamoxifen: All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery. Breast cancer surgery: Breast cancer surgery
Vascular disorders Thromboembolic Event	1.9% 1/52 • Number of events 1

Other adverse events

Measure	Tamoxifen Pre and Post Breast Surgery n=52 participants at risk All patients enrolled in the study. Tamoxifen: All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery. Breast cancer surgery: Breast cancer surgery
Eye disorders Blurred Vision	5.8% 3/52 • Number of events 3
Eye disorders Dialated Left Pupil	1.9% 1/52 • Number of events 1
Gastrointestinal disorders Abdominal Pain	1.9% 1/52 • Number of events 1
Gastrointestinal disorders Bloating	5.8% 3/52 • Number of events 3
Gastrointestinal disorders Constipation	5.8% 3/52 • Number of events 3
Gastrointestinal disorders Diarrhea	5.8% 3/52 • Number of events 3
Gastrointestinal disorders dry mouth	3.8% 2/52 • Number of events 2
Gastrointestinal disorders flatulence	3.8% 2/52 • Number of events 2
Gastrointestinal disorders lip swelling	1.9% 1/52 • Number of events 1
Gastrointestinal disorders Nausea	21.2% 11/52 • Number of events 14
Gastrointestinal disorders oral pain	1.9% 1/52 • Number of events 1
Gastrointestinal disorders toothache	1.9% 1/52 • Number of events 1
Gastrointestinal disorders vomiting	3.8% 2/52 • Number of events 2
General disorders fatigue	9.6% 5/52 • Number of events 5
General disorders irritability	1.9% 1/52 • Number of events 1
Infections and infestations vaginal infection	1.9% 1/52 • Number of events 1
Injury, poisoning and procedural complications bruising	1.9% 1/52 • Number of events 1
Metabolism and nutrition disorders anorexia	1.9% 1/52 • Number of events 1
Musculoskeletal and connective tissue disorders arthralgia	5.8% 3/52 • Number of events 3
Musculoskeletal and connective tissue disorders back pain	3.8% 2/52 • Number of events 2
Musculoskeletal and connective tissue disorders flank pain	1.9% 1/52 • Number of events 1
Musculoskeletal and connective tissue disorders myalgia	3.8% 2/52 • Number of events 2
Musculoskeletal and connective tissue disorders pain in extremity	1.9% 1/52 • Number of events 1
Nervous system disorders akathisia	1.9% 1/52 • Number of events 1
Nervous system disorders dizziness	5.8% 3/52 • Number of events 3
Nervous system disorders dysgeusia	3.8% 2/52 • Number of events 2
Nervous system disorders headache	9.6% 5/52 • Number of events 5
Psychiatric disorders anxiety	1.9% 1/52 • Number of events 1
Psychiatric disorders insomnia	9.6% 5/52 • Number of events 5
Reproductive system and breast disorders breast pain	1.9% 1/52 • Number of events 1
Reproductive system and breast disorders period spotting	1.9% 1/52 • Number of events 1
Reproductive system and breast disorders vaginal discharge	3.8% 2/52 • Number of events 2
Respiratory, thoracic and mediastinal disorders cough	7.7% 4/52 • Number of events 4
Respiratory, thoracic and mediastinal disorders dyspnea	1.9% 1/52 • Number of events 1
Respiratory, thoracic and mediastinal disorders nasal swelling	1.9% 1/52 • Number of events 1
Skin and subcutaneous tissue disorders dry skin	1.9% 1/52 • Number of events 1
Skin and subcutaneous tissue disorders Hyperhidrosis	1.9% 1/52 • Number of events 1
Skin and subcutaneous tissue disorders Rash acneiform	1.9% 1/52 • Number of events 1
Skin and subcutaneous tissue disorders rash maculopapular	1.9% 1/52 • Number of events 1
Vascular disorders flushing	1.9% 1/52 • Number of events 1
Vascular disorders hot flashes	36.5% 19/52 • Number of events 21

Additional Information

Josiah Hawks

Huntsman Cancer Institute

Phone: 8015850601

Email: Josiah.Hawks@hci.utah.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place