Trial Outcomes & Findings for Effects of GnRHa on Ovarian Function Against Chemotherapy-induced-gonadotoxicity (NCT NCT02518191)

NCT ID: NCT02518191

Last Updated: 2021-06-11

Results Overview

The serum levels of anti-Müllerian hormone (AMH) were measured using human AMH ELISA kit (11351, Biofine)). POI (premature ovarian insufficiency) was defined as AMH\<0.5ng/mL in this study.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 345 participants
• Primary outcome timeframe: 1 years
• Results posted on: 2021-06-11

Participant Flow

27 (6.67%) patients quit voluntarily after careful consideration, 33 patients who did not meet the inclusion criteria were excluded.

Participant milestones

Measure	GnRHa Group Eligible patients with breast cancer treated with GnRHa while receiving chemotherapy. GnRHa: 3.6mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy.	None GnRHa Group Eligible patients with breast cancer treated without GnRHa while receiving chemotherapy.
Overall Study STARTED	171	174
Overall Study COMPLETED	165	165
Overall Study NOT COMPLETED	6	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of GnRHa on Ovarian Function Against Chemotherapy-induced-gonadotoxicity

Baseline characteristics by cohort

Measure	GnRHa (Gonadotrophin-releasing Hormone Analogues) Group n=165 Participants Eligible patients with breast cancer treated with Gonadotrophin-releasing hormone analogues （GnRHa） while receiving chemotherapy. Goserelin 3.6mg, or leuprorelin 3.75mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy.	None GnRHa (Gonadotrophin-releasing Hormone Analogues) Group n=165 Participants Eligible patients with breast cancer treated without GnRHa while receiving chemotherapy.	Total n=330 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	165 Participants n=5 Participants	165 Participants n=7 Participants	330 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	40 years STANDARD_DEVIATION 6.65 • n=5 Participants	40 years STANDARD_DEVIATION 5.85 • n=7 Participants	40 years STANDARD_DEVIATION 6.26 • n=5 Participants
Sex: Female, Male Female	165 Participants n=5 Participants	165 Participants n=7 Participants	330 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized CHINA	165 participants n=5 Participants	165 participants n=7 Participants	330 participants n=5 Participants
Region of Enrollment China	165 participants n=5 Participants	165 participants n=7 Participants	330 participants n=5 Participants
anti-Müllerian hormone (AMH)	1.84 ng/mL STANDARD_DEVIATION 1.299 • n=5 Participants	1.78 ng/mL STANDARD_DEVIATION 1.102 • n=7 Participants	1.81 ng/mL STANDARD_DEVIATION 1.203 • n=5 Participants

PRIMARY outcome

Timeframe: 1 years

The serum levels of anti-Müllerian hormone (AMH) were measured using human AMH ELISA kit (11351, Biofine)). POI (premature ovarian insufficiency) was defined as AMH<0.5ng/mL in this study.

Outcome measures

Measure	GnRHa (Gonadotrophin-releasing Hormone Analogues) Group n=165 Participants Eligible patients with breast cancer treated with GnRHa (Gonadotrophin-releasing Hormone Analogues) while receiving chemotherapy. Goserelin 3.6mg, or leuprorelin 3.75mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy.	None GnRHa (Gonadotrophin-releasing Hormone Analogues) Group n=165 Participants Eligible patients with breast cancer treated without GnRHa (Gonadotrophin-releasing Hormone Analogues) while receiving chemotherapy.
Number of Participants With Premature Ovarian Insufficiency	10 Participants	38 Participants

SECONDARY outcome

Timeframe: 5 years

Overall Survival & Tumor Free Survival

Outcome measures

Measure	GnRHa (Gonadotrophin-releasing Hormone Analogues) Group n=165 Participants Eligible patients with breast cancer treated with GnRHa (Gonadotrophin-releasing Hormone Analogues) while receiving chemotherapy. Goserelin 3.6mg, or leuprorelin 3.75mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy.	None GnRHa (Gonadotrophin-releasing Hormone Analogues) Group n=165 Participants Eligible patients with breast cancer treated without GnRHa (Gonadotrophin-releasing Hormone Analogues) while receiving chemotherapy.
Survival Rate	48.17 months Interval 26.0 to 60.0	49.33 months Interval 25.0 to 59.0

Adverse Events

GnRHa Group

Serious events: 0 serious events

Other events: 165 other events

Deaths: 4 deaths

None GnRHa Group

Serious events: 0 serious events

Other events: 165 other events

Deaths: 5 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	GnRHa Group n=165 participants at risk Eligible patients with breast cancer treated with GnRHa while receiving chemotherapy. GnRHa: 3.6mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy.	None GnRHa Group n=165 participants at risk Eligible patients with breast cancer treated without GnRHa while receiving chemotherapy.
Endocrine disorders fatique	100.0% 165/165 • Number of events 165 • 6months	100.0% 165/165 • Number of events 165 • 6months

Additional Information

Dr. ZONG

Shanghai 6th People's Hospital Affiliated to Shanghai Jiao Tong University

Phone: 86 (21) 24058549

Email: tigerzong@msn.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place