Trial Outcomes & Findings for Predictors of Ovarian Insufficiency in Young Breast Cancer Patients (NCT NCT01197456)

Results Overview

Number of participant without of menses for 12 months after breast cancer diagnosis

Recruitment status

COMPLETED

Target enrollment

232 participants

Primary outcome timeframe

Years 1-5

Results posted on

2020-04-22

Participant Flow

Participant milestones

Participant milestones
Measure	Exposed/Chemotherapy Breast cancer patients who will undergo chemotherapy	Unexposed Breast cancer patients who will not undergo chemotherapy
Overall Study STARTED	171	61
Overall Study COMPLETED	171	61
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Predictors of Ovarian Insufficiency in Young Breast Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exposed/Chemotherapy n=171 Participants Breast cancer patients who will undergo chemotherapy	Unexposed n=61 Participants Breast cancer patients who will not undergo chemotherapy	Total n=232 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	171 Participants n=5 Participants	61 Participants n=7 Participants	232 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	38.7 years STANDARD_DEVIATION 5.1 • n=5 Participants	41.0 years STANDARD_DEVIATION 5.7 • n=7 Participants	39.3 years STANDARD_DEVIATION 5.4 • n=5 Participants
Sex: Female, Male Female	171 Participants n=5 Participants	61 Participants n=7 Participants	232 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 United States	171 Participants n=5 Participants	61 Participants n=7 Participants	232 Participants n=5 Participants

PRIMARY outcome

Timeframe: Years 1-5

Population: 25 participants could not be evaluated for this outcome due to censoring for cancer recurrence, death, bilateral salpingo-oophorectomy, or hysterectomy. 38 additional participants could not be evaluated for this outcome due to loss to follow up.

Number of participant without of menses for 12 months after breast cancer diagnosis

Outcome measures

Outcome measures
Measure	Exposed/Chemotherapy n=128 Participants Breast cancer patients who will undergo chemotherapy	Unexposed n=41 Participants Breast cancer patients who will not undergo chemotherapy
Number of Participant Ovarian Insufficiency (Without of Menses for 12 Months) After Breast Cancer Diagnosis	27 Participants	11 Participants

SECONDARY outcome

Timeframe: Years 1-5

Population: We did not undertake this analysis for participants who did not undergo chemotherapy (unexposed) or were censored for recurrence, death, hysterectomy or bilateral salpingo-oophorectomy (n=108) as this measure is not applicable

Number of participants who experience return of menses after 3 months of amenorrhea

Outcome measures

Outcome measures
Measure	Exposed/Chemotherapy n=124 Participants Breast cancer patients who will undergo chemotherapy	Unexposed Breast cancer patients who will not undergo chemotherapy
Number of Participants Who Experience Return of Menses After 3 Months of Amenorrhea	62 Participants	0 Participants

Adverse Events

Exposed/Chemotherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Unexposed

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Irene Su, MD MSCE

UC San Diego

Phone: 858-822-5986

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place