Trial Outcomes & Findings for Preoperative Hormone Therapy for Postmenopausal Women With ER+ Clinical Stage T2-4 Tumors (NCT NCT01831076)

Last Updated: 2022-03-03

Results Overview

Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Evaluated using chi-square analysis.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

Up to 6 months

Results posted on

2022-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	Exemestane Patients receive exemestane orally daily for 4 months in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery. Exemestane: Given PO	Exemestane Plus Tamoxifen preoperative exemestane plus concurrent tamoxifen for 4 months, then surgery. Patients with \>T2 ER+ Her2- BC.
Overall Study STARTED	31	5
Overall Study COMPLETED	30	4
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preoperative Hormone Therapy for Postmenopausal Women With ER+ Clinical Stage T2-4 Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exemestane n=31 Participants Patients receive exemestane orally daily for 4 months in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery. Exemestane: Given PO	Exemestane Plus Tamoxifen n=5 Participants preoperative exemestane plus concurrent tamoxifen for 4 months, then surgery. Patients with \>T2 ER+ Her2- BC.	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	4 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	1 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	5 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	5 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants	5 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 months

Outcome measures

Outcome measures
Measure	Exemestane n=31 Participants Patients receive exemestane orally daily for 4 months in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery. Exemestane: Given PO	Exemestane Plus Tamoxifen n=5 Participants preoperative exemestane plus concurrent tamoxifen for 4 months, then surgery. Patients with \>T2 ER+ Her2- BC.
Overall Response Rate as Measured by Clinical Exam, Standard Imaging, and Surgical Pathology Findings	23 Participants	0 Participants

Adverse Events

Exemestane

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Exemestane Plus Tamoxifen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anthony Elias

University of Colorado

Phone: 720-848-0347

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place