Trial Outcomes & Findings for Pre-Surgical Intervention for Targeted Therapies for Breast Cancer (NCT NCT01004744)

Results Overview

The number of subjects who complete oral anastrozole for the length of the study is analyzed. The subjects receive oral anastrozole 1mg daily for two weeks in the interval between the biopsy and the surgery.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

Two weeks

Results posted on

2021-01-11

Participant Flow

Patients will be identified by the breast surgeon or mammographer performing the breast biopsy. Patients with histologically-confirmed ER+ invasive or non-invasive breast cancer will be recruited by the medical oncologist and will start anastrozole two weeks prior to their scheduled surgery.

Participant milestones

Participant milestones
Measure	Presurgical Oral Anastrozole 1mg daily for two weeks in the interval between diagnostic breast biopsy and definitive breast surgery. Anastrozole: 1mg PO daily for two weeks prior to scheduled surgery
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pre-Surgical Intervention for Targeted Therapies for Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Presurgical Oral Anastrozole n=10 Participants 1mg daily for two weeks in the interval between diagnostic breast biopsy and definitive breast surgery. Anastrozole: 1mg PO daily for two weeks prior to scheduled surgery
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	66 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Two weeks

The number of subjects who complete oral anastrozole for the length of the study is analyzed. The subjects receive oral anastrozole 1mg daily for two weeks in the interval between the biopsy and the surgery.

Outcome measures

Outcome measures
Measure	Presurgical Oral Anastrozole n=10 Participants 1mg daily for two weeks in the interval between diagnostic breast biopsy and definitive breast surgery. Anastrozole: 1mg PO daily for two weeks prior to scheduled surgery
Number of Subjects That Completed Oral Anastrozole 1mg Daily for Two Weeks in the Interval Between Diagnostic Breast Biopsy and Definitive Breast Surgery	10 participants

Adverse Events

Presurgical Oral Anastrozole

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Presurgical Oral Anastrozole n=10 participants at risk 1mg daily for two weeks in the interval between diagnostic breast biopsy and definitive breast surgery. Anastrozole: 1mg PO daily for two weeks prior to scheduled surgery
Gastrointestinal disorders Diarrhea	40.0% 4/10
General disorders Fatigue	40.0% 4/10
Vascular disorders Hot flashes	40.0% 4/10

Additional Information

Dr. Katherine Crew

Columbia University

Phone: 212-305-1732

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place