Trial Outcomes & Findings for Goserelin Acetate Study for Ovarian Function in Patients With Primary Breast Cancer (NCT NCT00429403)

Results Overview

Outcome characterized in terms of two variables, each measured repeatedly over time: Follicle-stimulating hormone (FSH) level and whether vaginal bleeding occurs, each to be measured from the end of chemotherapy. For treatment comparison, "response" defined as a composite event: both \[FSH \< 15\] and vaginal bleeding observed within 12 months after the end of chemotherapy, with both FSH and vaginal bleeding baseline observed before start of chemotherapy.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

1 participants

Primary outcome timeframe

Baseline prior to chemotherapy then every 3 months after chemotherapy for 1 year

Results posted on

2016-05-09

Participant Flow

Period of Recruitment: August 30, 2006 to August 25, 2009. All patient recruitment made at UT MD Anderson Cancer Center.

Study terminated early due to slow accrual.

Participant milestones

Participant milestones
Measure	Goserelin 3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.	No Goserelin
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Goserelin Acetate Study for Ovarian Function in Patients With Primary Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Goserelin n=1 Participants 3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.	No Goserelin	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 years n=99 Participants	—	0 years n=206 Participants
Age, Categorical Between 18 and 65 years	1 years n=99 Participants	—	1 years n=206 Participants
Age, Categorical >=65 years	0 years n=99 Participants	—	0 years n=206 Participants
Gender Female	1 participants n=99 Participants	—	1 participants n=206 Participants
Gender Male	0 participants n=99 Participants	—	0 participants n=206 Participants
Region of Enrollment United States	1 participants n=99 Participants	—	1 participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline prior to chemotherapy then every 3 months after chemotherapy for 1 year

Population: Analysis was per protocol. Limited analysis due to low recruitment and early termination.

Outcome characterized in terms of two variables, each measured repeatedly over time: Follicle-stimulating hormone (FSH) level and whether vaginal bleeding occurs, each to be measured from the end of chemotherapy. For treatment comparison, "response" defined as a composite event: both \[FSH \< 15\] and vaginal bleeding observed within 12 months after the end of chemotherapy, with both FSH and vaginal bleeding baseline observed before start of chemotherapy.

Outcome measures

Outcome measures
Measure	Goserelin n=1 Participants 3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.	No Goserelin
Number of Patients With Response (FSH Level + Vaginal Bleeding)	1 participants	—

Adverse Events

Goserelin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Goserelin

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

Naoto Ueno, MD / Professor

UT MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place