Breast Cancer
Conditions
Keywords
GnRHa, ovarian function, anti-mullerian hormone
Brief summary
This prospective randomized controlled study is conducted to analyze the effect of Goserelin on ovarian function in women with breast cancer in China.
Interventions
DRUGGnRHa
3.6mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy.
Sponsors
Zhejiang Cancer Hospital
Xiangyun Zong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* Premenopausal women 18 to 49 years of age are eligible for enrollment * Patients have operable stage I to IIIA breast cancer for which treatment with adjuvant or neoadjuvant cyclophosphamide-containing chemotherapy was planned. * Eligible participants had taken no estrogens, antiestrogens, selective estrogen-receptor modulators, aromatase inhibitors, or hormonal contraceptives within the month before enrollment. * Human chorionic gonadotropin negative by urine test before entering the group. * Informed consent, understanding and compliance with the requirements of the study. * No significant chronic disease and any organ dysfunction.
Exclusion criteria
* Exceptions were made for the use of hormonal contraception in women younger than 35 years of age that was discontinued before randomization. * Use of hormonal treatment for up to 2 months for the purposes of in vitro fertilization and cryopreservation of embryos or oocytes before randomization. * Patients with metastatic lesions or history of bilateral ovariectomy,ovarian radiation were excluded. * Patients received previous adjuvant endocrine therapy for breast cancer are not suitable to this trial. * Patients with uterine and/or adnexal diseases needing medical or surgical treatment are not suitable. * Allergic to active or inactive excipients of GnRHa is an exclusion criterion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Premature Ovarian Insufficiency | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival Rate | 5 years | Overall Survival & Tumor Free Survival |
Countries
China
Participant flow
Pre-assignment details
27 (6.67%) patients quit voluntarily after careful consideration, 33 patients who did not meet the inclusion criteria were excluded.
Participants by arm
| Arm | Count |
|---|---|
| GnRHa (Gonadotrophin-releasing Hormone Analogues) Group 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. | 165 |
| None GnRHa (Gonadotrophin-releasing Hormone Analogues) Group Eligible patients with breast cancer treated without GnRHa while receiving chemotherapy. | 165 |
| Total | 330 |
Baseline characteristics
| Characteristic | GnRHa (Gonadotrophin-releasing Hormone Analogues) Group | None GnRHa (Gonadotrophin-releasing Hormone Analogues) Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 165 Participants | 165 Participants | 330 Participants |
| Age, Continuous | 40 years STANDARD_DEVIATION 6.65 | 40 years STANDARD_DEVIATION 5.85 | 40 years STANDARD_DEVIATION 6.26 |
| anti-Müllerian hormone (AMH) | 1.84 ng/mL STANDARD_DEVIATION 1.299 | 1.78 ng/mL STANDARD_DEVIATION 1.102 | 1.81 ng/mL STANDARD_DEVIATION 1.203 |
| Race/Ethnicity, Customized CHINA | 165 participants | 165 participants | 330 participants |
| Region of Enrollment China | 165 participants | 165 participants | 330 participants |
| Sex: Female, Male Female | 165 Participants | 165 Participants | 330 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 165 | 5 / 165 |
| other Total, other adverse events | 165 / 165 | 165 / 165 |
| serious Total, serious adverse events | 0 / 165 | 0 / 165 |
Outcome results
Primary
Number of Participants With Premature Ovarian Insufficiency
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.
Time frame: 1 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GnRHa (Gonadotrophin-releasing Hormone Analogues) Group | Number of Participants With Premature Ovarian Insufficiency | 10 Participants |
| None GnRHa (Gonadotrophin-releasing Hormone Analogues) Group | Number of Participants With Premature Ovarian Insufficiency | 38 Participants |
Secondary
Survival Rate
Overall Survival & Tumor Free Survival
Time frame: 5 years
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GnRHa (Gonadotrophin-releasing Hormone Analogues) Group | Survival Rate | 48.17 months |
| None GnRHa (Gonadotrophin-releasing Hormone Analogues) Group | Survival Rate | 49.33 months |