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

A Phase 3 study testing GnRHa in people with Breast Cancer, run by Xiangyun Zong at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This prospective randomized controlled study is conducted to analyze the effect of Goserelin on ovarian function in women with breast cancer in China. Read more about this study

Who is it for?: Ages 18 to 49 years, women only
Conditions the study is for: Breast Cancer
What is being tested?: GnRHa
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 345 participants
Where: 2 sitesChina
Study dates: 1 Sep 2015to 12 Jan 2021
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 49 years
Women only
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, 200233

Other trials in China

About this study

Official title: Effects of GnRHa on Ovarian Function Against Chemotherapy-induced-gonadotoxicity in Women With Breast Cancer in China

This prospective randomized controlled study is conducted to analyze the effect of Goserelin on ovarian function in women with breast cancer in China.

Conditions: Breast Cancer
Being tested: GnRHa
Keywords: GnRHa, ovarian function, anti-mullerian hormone
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GnRHaDrug
Also called goserelin
3.6mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy.

Study groups in NCT02518191
Study group	Role	What they receive
GnRHa group	Experimental	Eligible patients with breast cancer treated with GnRHa while receiving chemotherapy. Receives: Drug: GnRHa
None GnRHa group	No intervention	Eligible patients with breast cancer treated without GnRHa while receiving chemotherapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 years

Secondary outcomes (1)

Survival Rate
Overall Survival \& Tumor Free Survival
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201512 Jan 2021

First posted7 Aug 2015 (estimated)
Study start1 Sep 2015
Primary completion12 Jan 2021
Study completion12 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 345 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02518191
Sponsor's protocol ID: JTU-6H-20150731001
Status last verified: May 2021
First submitted: 5 Aug 2015
Last updated: 11 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Baum M, Hackshaw A, Houghton J, Rutqvist, Fornander T, Nordenskjold B, Nicolucci A, Sainsbury R; ZIPP International Collaborators Group. Adjuvant goserelin in pre-menopausal patients with early breast cancer: Results from the ZIPP study. Eur J Cancer. 2006 May;42(7):895-904. doi: 10.1016/j.ejca.2005.12.013. Epub 2006 Mar 20.
PubMed 16545560
Kaufmann M, Jonat W, Blamey R, Cuzick J, Namer M, Fogelman I, de Haes JC, Schumacher M, Sauerbrei W; Zoladex Early Breast Cancer Research Association (ZEBRA) Trialists' Group. Survival analyses from the ZEBRA study. goserelin (Zoladex) versus CMF in premenopausal women with node-positive breast cancer. Eur J Cancer. 2003 Aug;39(12):1711-7. doi: 10.1016/s0959-8049(03)00392-7.
PubMed 12888366
Davidson NE, O'Neill AM, Vukov AM, Osborne CK, Martino S, White DR, Abeloff MD. Chemoendocrine therapy for premenopausal women with axillary lymph node-positive, steroid hormone receptor-positive breast cancer: results from INT 0101 (E5188). J Clin Oncol. 2005 Sep 1;23(25):5973-82. doi: 10.1200/JCO.2005.05.551. Epub 2005 Aug 8.
PubMed 16087950
LHRH-agonists in Early Breast Cancer Overview group; Cuzick J, Ambroisine L, Davidson N, Jakesz R, Kaufmann M, Regan M, Sainsbury R. Use of luteinising-hormone-releasing hormone agonists as adjuvant treatment in premenopausal patients with hormone-receptor-positive breast cancer: a meta-analysis of individual patient data from randomised adjuvant trials. Lancet. 2007 May 19;369(9574):1711-23. doi: 10.1016/S0140-6736(07)60778-8.
PubMed 17512856
Yang H, Zong X, Yu Y, Shao G, Zhang L, Qian C, Bian Y, Xu X, Sun W, Meng X, Ding X, Chen D, Zou D, Xie S, Zheng Y, Zhang J, He X, Sun C, Yu X, Ni J. Combined effects of goserelin and tamoxifen on estradiol level, breast density, and endometrial thickness in premenopausal and perimenopausal women with early-stage hormone receptor-positive breast cancer: a randomised controlled clinical trial. Br J Cancer. 2013 Aug 6;109(3):582-8. doi: 10.1038/bjc.2013.324. Epub 2013 Jul 16.
PubMed 23860520
Sarafoglou K, Boulad F, Gillio A, Sklar C. Gonadal function after bone marrow transplantation for acute leukemia during childhood. J Pediatr. 1997 Feb;130(2):210-6. doi: 10.1016/s0022-3476(97)70345-7.
PubMed 9042122
Chemaitilly W, Mertens AC, Mitby P, Whitton J, Stovall M, Yasui Y, Robison LL, Sklar CA. Acute ovarian failure in the childhood cancer survivor study. J Clin Endocrinol Metab. 2006 May;91(5):1723-8. doi: 10.1210/jc.2006-0020. Epub 2006 Feb 21.
PubMed 16492690
Green DM, Sklar CA, Boice JD Jr, Mulvihill JJ, Whitton JA, Stovall M, Yasui Y. Ovarian failure and reproductive outcomes after childhood cancer treatment: results from the Childhood Cancer Survivor Study. J Clin Oncol. 2009 May 10;27(14):2374-81. doi: 10.1200/JCO.2008.21.1839. Epub 2009 Apr 13.
PubMed 19364956
Wallace WH, Thomson AB, Saran F, Kelsey TW. Predicting age of ovarian failure after radiation to a field that includes the ovaries. Int J Radiat Oncol Biol Phys. 2005 Jul 1;62(3):738-44. doi: 10.1016/j.ijrobp.2004.11.038.
PubMed 15936554
Oktem O, Oktay K. Quantitative assessment of the impact of chemotherapy on ovarian follicle reserve and stromal function. Cancer. 2007 Nov 15;110(10):2222-9. doi: 10.1002/cncr.23071.
PubMed 17932880
Blumenfeld Z, Avivi I, Ritter M, Rowe JM. Preservation of fertility and ovarian function and minimizing chemotherapy-induced gonadotoxicity in young women. J Soc Gynecol Investig. 1999 Sep-Oct;6(5):229-39. doi: 10.1016/s1071-5576(99)00028-3.
PubMed 10554760
Blumenfeld Z. How to preserve fertility in young women exposed to chemotherapy? The role of GnRH agonist cotreatment in addition to cryopreservation of embrya, oocytes, or ovaries. Oncologist. 2007 Sep;12(9):1044-54. doi: 10.1634/theoncologist.12-9-1044.
PubMed 17914074
Meirow D, Assad G, Dor J, Rabinovici J. The GnRH antagonist cetrorelix reduces cyclophosphamide-induced ovarian follicular destruction in mice. Hum Reprod. 2004 Jun;19(6):1294-9. doi: 10.1093/humrep/deh257. Epub 2004 Apr 29.
PubMed 15117898
Osborne SE, Detti L. GnRH-analogues for ovarian protection in childhood cancer patients: how adult hypotheses are relevant in prepubertal females. Curr Drug Targets. 2013 Jul;14(8):856-63. doi: 10.2174/1389450111314080005.
PubMed 23614679
Decanter C, Morschhauser F, Pigny P, Lefebvre C, Gallo C, Dewailly D. Anti-Mullerian hormone follow-up in young women treated by chemotherapy for lymphoma: preliminary results. Reprod Biomed Online. 2010 Feb;20(2):280-5. doi: 10.1016/j.rbmo.2009.11.010. Epub 2009 Dec 3.
PubMed 20113967

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of GnRHa on Ovarian Function Against Chemotherapy-induced-gonadotoxicity in Women With Breast Cancer in China
ClinicalTrials.gov ID: NCT02518191
Acronym / sponsor ID: JTU-6H-20150731001
Conditions: Breast Cancer
Keywords: GnRHa, ovarian function, anti-mullerian hormone
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 345 participants (actual)
Lead sponsor: Xiangyun ZongUniversity, hospital or other
Collaborators: Zhejiang Cancer Hospital
Study start: 1 Sep 2015 (actual)
Primary completion: 12 Jan 2021 (actual)
Study completion: 12 Jan 2021 (actual)
First posted: 7 Aug 2015 (estimated)
Results: Posted 3 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This prospective randomized controlled study is conducted to analyze the effect of Goserelin on ovarian function in women with breast cancer in China.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
GnRHa group	Experimental	Drug: GnRHaEligible patients with breast cancer treated with GnRHa while receiving chemotherapy.
None GnRHa group	No intervention	–Eligible patients with breast cancer treated without GnRHa while receiving chemotherapy.

Who may qualify

Ages: 18 to 49 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GnRHaAlso: goserelin3.6mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy.	Drug	GnRHa group

Primary outcome

Number of Participants With Premature Ovarian Insufficiency
Time frame: 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.

1 secondary outcome

Survival Rate
Time frame: 5 years

Results and safety

Results posted to the registry on 3 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GnRHa Group	171	165
None GnRHa Group	174	165

Primary outcome: Number of Participants With Premature Ovarian Insufficiency

Time frame: 1 years. Count of participants. Unit: Participants

Measure	GnRHa (Gonadotrophin-releasing Hormone Analogues) Group n = 165	None GnRHa (Gonadotrophin-releasing Hormone Analogues) Group n = 165
Value	10	38

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GnRHa Group	0 of 165 (0%)	165 of 165 (100%)	4 of 165
None GnRHa Group	0 of 165 (0%)	165 of 165 (100%)	5 of 165

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16545560Baum M, Hackshaw A, Houghton J, Rutqvist, Fornander T, Nordenskjold B, Nicolucci A, Sainsbury R; ZIPP International Collaborators Group. Adjuvant goserelin in pre-menopausal patients with early breast cancer: Results from the ZIPP study. Eur J Cancer. 2006 May;42(7):895-904. doi: 10.1016/j.ejca.2005.12.013. Epub 2006 Mar 20.
Background: PubMed 12888366Kaufmann M, Jonat W, Blamey R, Cuzick J, Namer M, Fogelman I, de Haes JC, Schumacher M, Sauerbrei W; Zoladex Early Breast Cancer Research Association (ZEBRA) Trialists' Group. Survival analyses from the ZEBRA study. goserelin (Zoladex) versus CMF in premenopausal women with node-positive breast cancer. Eur J Cancer. 2003 Aug;39(12):1711-7. doi: 10.1016/s0959-8049(03)00392-7.
Background: PubMed 16087950Davidson NE, O'Neill AM, Vukov AM, Osborne CK, Martino S, White DR, Abeloff MD. Chemoendocrine therapy for premenopausal women with axillary lymph node-positive, steroid hormone receptor-positive breast cancer: results from INT 0101 (E5188). J Clin Oncol. 2005 Sep 1;23(25):5973-82. doi: 10.1200/JCO.2005.05.551. Epub 2005 Aug 8.
Background: PubMed 17512856LHRH-agonists in Early Breast Cancer Overview group; Cuzick J, Ambroisine L, Davidson N, Jakesz R, Kaufmann M, Regan M, Sainsbury R. Use of luteinising-hormone-releasing hormone agonists as adjuvant treatment in premenopausal patients with hormone-receptor-positive breast cancer: a meta-analysis of individual patient data from randomised adjuvant trials. Lancet. 2007 May 19;369(9574):1711-23. doi: 10.1016/S0140-6736(07)60778-8.
Background: PubMed 23860520Yang H, Zong X, Yu Y, Shao G, Zhang L, Qian C, Bian Y, Xu X, Sun W, Meng X, Ding X, Chen D, Zou D, Xie S, Zheng Y, Zhang J, He X, Sun C, Yu X, Ni J. Combined effects of goserelin and tamoxifen on estradiol level, breast density, and endometrial thickness in premenopausal and perimenopausal women with early-stage hormone receptor-positive breast cancer: a randomised controlled clinical trial. Br J Cancer. 2013 Aug 6;109(3):582-8. doi: 10.1038/bjc.2013.324. Epub 2013 Jul 16.
Background: PubMed 9042122Sarafoglou K, Boulad F, Gillio A, Sklar C. Gonadal function after bone marrow transplantation for acute leukemia during childhood. J Pediatr. 1997 Feb;130(2):210-6. doi: 10.1016/s0022-3476(97)70345-7.
Background: PubMed 16492690Chemaitilly W, Mertens AC, Mitby P, Whitton J, Stovall M, Yasui Y, Robison LL, Sklar CA. Acute ovarian failure in the childhood cancer survivor study. J Clin Endocrinol Metab. 2006 May;91(5):1723-8. doi: 10.1210/jc.2006-0020. Epub 2006 Feb 21.
Background: PubMed 19364956Green DM, Sklar CA, Boice JD Jr, Mulvihill JJ, Whitton JA, Stovall M, Yasui Y. Ovarian failure and reproductive outcomes after childhood cancer treatment: results from the Childhood Cancer Survivor Study. J Clin Oncol. 2009 May 10;27(14):2374-81. doi: 10.1200/JCO.2008.21.1839. Epub 2009 Apr 13.
Background: PubMed 15936554Wallace WH, Thomson AB, Saran F, Kelsey TW. Predicting age of ovarian failure after radiation to a field that includes the ovaries. Int J Radiat Oncol Biol Phys. 2005 Jul 1;62(3):738-44. doi: 10.1016/j.ijrobp.2004.11.038.
Background: PubMed 17932880Oktem O, Oktay K. Quantitative assessment of the impact of chemotherapy on ovarian follicle reserve and stromal function. Cancer. 2007 Nov 15;110(10):2222-9. doi: 10.1002/cncr.23071.
Background: PubMed 10554760Blumenfeld Z, Avivi I, Ritter M, Rowe JM. Preservation of fertility and ovarian function and minimizing chemotherapy-induced gonadotoxicity in young women. J Soc Gynecol Investig. 1999 Sep-Oct;6(5):229-39. doi: 10.1016/s1071-5576(99)00028-3.
Background: PubMed 17914074Blumenfeld Z. How to preserve fertility in young women exposed to chemotherapy? The role of GnRH agonist cotreatment in addition to cryopreservation of embrya, oocytes, or ovaries. Oncologist. 2007 Sep;12(9):1044-54. doi: 10.1634/theoncologist.12-9-1044.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

XIANGYUN ZONG, MD, PhD principal investigator

Shanghai Jiao Tong University affiliated 6th Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GnRHa in people with Breast Cancer, run by Xiangyun Zong at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Premature Ovarian Insufficiency (time frame: 1 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02518191, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.