Trial Outcomes & Findings for Luteal vs Follicular Surgical Oophorectomy and Tamoxifen in Premenopausal Women With Metastatic Hormone Receptor Positive Breast Cancer (NCT NCT00293540)

Last Updated: 2016-07-27

Results Overview

Assess whether patients who undergo surgical oophorectomy in the history-estimated mid-luteal phase of their menstrual cycles survive longer than patients who undergo this surgery in the history-estimated mid-follicular phase of their menstrual cycles.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

249 participants

Primary outcome timeframe

Up to 9 years

Results posted on

2016-07-27

Participant Flow

Participant milestones

Participant milestones
Measure	A Mid-luteal Surgery	B Mid-follicular Surgery
Overall Study STARTED	122	127
Overall Study COMPLETED	115	119
Overall Study NOT COMPLETED	7	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Luteal vs Follicular Surgical Oophorectomy and Tamoxifen in Premenopausal Women With Metastatic Hormone Receptor Positive Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A Mid-luteal Surgery n=115 Participants	B Mid-follicular Surgery n=119 Participants	Total n=234 Participants Total of all reporting groups
Age, Continuous	39.0 years STANDARD_DEVIATION 5.4 • n=5 Participants	38.6 years STANDARD_DEVIATION 5.7 • n=7 Participants	38.8 years STANDARD_DEVIATION 5.6 • n=5 Participants
Sex: Female, Male Female	115 Participants n=5 Participants	119 Participants n=7 Participants	234 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Vietnam	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Bangladesh	50 participants n=5 Participants	48 participants n=7 Participants	98 participants n=5 Participants
Region of Enrollment Morocco	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Philippines	28 participants n=5 Participants	26 participants n=7 Participants	54 participants n=5 Participants
Region of Enrollment China	21 participants n=5 Participants	27 participants n=7 Participants	48 participants n=5 Participants
Region of Enrollment Malaysia	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Nigeria	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Region of Enrollment Indonesia	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment Taiwan	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants
Dominant metastatic site Soft tissue	76 participants n=5 Participants	83 participants n=7 Participants	159 participants n=5 Participants
Dominant metastatic site Bone	20 participants n=5 Participants	25 participants n=7 Participants	45 participants n=5 Participants
Dominant metastatic site Viscera	19 participants n=5 Participants	11 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 9 years

Population: Analyzed all patients with followup data

Outcome measures

Outcome measures
Measure	A Mid-luteal Surgery n=115 Participants	B Mid-follicular Surgery n=119 Participants
Overall Survival	2.14 years Interval 1.53 to 2.67	2.00 years Interval 1.61 to 2.31

Adverse Events

A Mid-luteal Surgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

B Mid-follicular Surgery

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	A Mid-luteal Surgery n=115 participants at risk	B Mid-follicular Surgery n=119 participants at risk
Blood and lymphatic system disorders Deep vein thrombosis	0.00% 0/115	0.84% 1/119 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Richard R. Love, MD

International Breast Cancer Research Foundation

Phone: 608-698-7881

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place