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=99 Participants	38.6 years STANDARD_DEVIATION 5.7 • n=107 Participants	38.8 years STANDARD_DEVIATION 5.6 • n=206 Participants
Sex: Female, Male Female	115 Participants n=99 Participants	119 Participants n=107 Participants	234 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment Vietnam	1 participants n=99 Participants	0 participants n=107 Participants	1 participants n=206 Participants
Region of Enrollment Bangladesh	50 participants n=99 Participants	48 participants n=107 Participants	98 participants n=206 Participants
Region of Enrollment Morocco	0 participants n=99 Participants	1 participants n=107 Participants	1 participants n=206 Participants
Region of Enrollment Philippines	28 participants n=99 Participants	26 participants n=107 Participants	54 participants n=206 Participants
Region of Enrollment China	21 participants n=99 Participants	27 participants n=107 Participants	48 participants n=206 Participants
Region of Enrollment Malaysia	3 participants n=99 Participants	3 participants n=107 Participants	6 participants n=206 Participants
Region of Enrollment Nigeria	6 participants n=99 Participants	6 participants n=107 Participants	12 participants n=206 Participants
Region of Enrollment Indonesia	3 participants n=99 Participants	4 participants n=107 Participants	7 participants n=206 Participants
Region of Enrollment Taiwan	3 participants n=99 Participants	4 participants n=107 Participants	7 participants n=206 Participants
Dominant metastatic site Soft tissue	76 participants n=99 Participants	83 participants n=107 Participants	159 participants n=206 Participants
Dominant metastatic site Bone	20 participants n=99 Participants	25 participants n=107 Participants	45 participants n=206 Participants
Dominant metastatic site Viscera	19 participants n=99 Participants	11 participants n=107 Participants	30 participants n=206 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