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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT02518191 (opens ClinicalTrials.gov in a new tab)Other idJTU-6H-20150731001
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
345 participants (actual)
Sponsor
Xiangyun Zong · Other
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
1 Sept 2015
Primary completion
12 Jan 2021
Completion
12 Jan 2021
First posted
7 Aug 2015 (estimated)
Last update posted
11 Jun 2021
Conditions
Breast Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2016201820202022
  1. Ph 3

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

    NCT02518191

    1 Sept 2015 to 12 Jan 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • GnRHaDrug

Arms2

  • Experimental

    GnRHa group

    Eligible patients with breast cancer treated with GnRHa while receiving chemotherapy.

  • No intervention

    None GnRHa group

    Eligible patients with breast cancer treated without GnRHa while receiving chemotherapy.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants With Premature Ovarian Insufficiency

    Time frame · 1 years

    Registry description

    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 outcomes(1)

  1. Survival Rate

    Time frame · 5 years

    Registry description

    Overall Survival \& Tumor Free Survival

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· 1 years

Number of Participants With Premature Ovarian Insufficiency

GroupValue (Participants)
GnRHa (Gonadotrophin-releasing Hormone Analogues) Group10
None GnRHa (Gonadotrophin-releasing Hormone Analogues) Group38
Secondary and other outcome results(1)
Secondary outcomeMean· 5 years

Survival Rate

GroupValue (months)
GnRHa Group48.17
None GnRHa Group49.33

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
GnRHa GroupEligible 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.4 / 1650 / 165165 / 165
None GnRHa GroupEligible patients with breast cancer treated without GnRHa while receiving chemotherapy.5 / 1650 / 165165 / 165

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies10

Studies that cite this trial.

Studies with results

5 studies on this page

Indexing hint: Randomized controlled trial · 2015

4 results

Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy.

Moore et al. 2015The New England journal of medicinecited by 368

PMID 25738668PMC4405231DOI 10.1056/nejmoa1413204PUB-25738668

Rights unknown4 results
Source linkSee results (4)

Indexing hint: Observational study · 2007

5 results

The effect of a GnRH agonist on cryopreserved human ovarian grafts in severe combined immunodeficient mice.

Maltaris et al. 2007Reproduction (Cambridge, England)cited by 29

PMID 17307918DOI 10.1530/rep-06-0061PUB-17307918

Rights unknown5 results
Source linkSee results (5)

Indexing hint: Randomized controlled trial · 2005

1 result

Chemoendocrine therapy for premenopausal women with axillary lymph node-positive, steroid hormone receptor-positive breast cancer: results from INT 0101 (E5188).

Davidson et al. 2005Journal of clinical oncology : official journal of the American Society of Clinical Oncologycited by 146

PMID 16087950DOI 10.1200/jco.2005.05.551PUB-16087950

Full text at the publisher1 result
Publisher pageSee results (1)

Indexing hint: Animal study · 2004

3 results

The GnRH antagonist cetrorelix reduces cyclophosphamide-induced ovarian follicular destruction in mice.

Meirow et al. 2004Human reproduction (Oxford, England)cited by 99

PMID 15117898DOI 10.1093/humrep/deh257PUB-15117898

Full text at the publisher3 results
Publisher pageSee results (3)

Indexing hint: Randomized controlled trial · 2003

6 results

Survival analyses from the ZEBRA study. goserelin (Zoladex) versus CMF in premenopausal women with node-positive breast cancer.

Kaufmann et al. 2003European journal of cancer (Oxford, England : 1990)cited by 72

PMID 12888366DOI 10.1016/s0959-8049(03)00392-7PUB-12888366

Full text at the publisher6 results
Publisher pageSee results (6)

More studies

5 studies on this page

Indexing hint: Randomized controlled trial · 2022

Effects of Gonadotropin-Releasing Hormone Analogs on Ovarian Function Against Chemotherapy-Induced Gonadotoxic Effects in Premenopausal Women With Breast Cancer in China: A Randomized Clinical Trial.

Zong et al. 2022JAMA oncologycited by 27

PMID 34967844PMC8719274DOI 10.1001/jamaoncol.2021.6214PUB-34967844

Rights unknown
Source link

Indexing hint: Animal study · 2014

Goserelin fosters bone elongation but does not prevent ovarian damage in cyclophosphamide-treated prepubertal mice.

Detti et al. 2014Fertility and sterilitycited by 12

PMID 24462062DOI 10.1016/j.fertnstert.2013.12.028PUB-24462062

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2013

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.

Yang et al. 2013British journal of cancercited by 13

PMID 23860520PMC3738136DOI 10.1038/bjc.2013.324PUB-23860520

Free to read · publisher termsCC BY-NC
Read at source

Indexing hint: Observational study · 2011

Is anti-Müllerian hormone a marker of acute cyclophosphamide-induced ovarian follicular destruction in mice pretreated with cetrorelix?

Browne et al. 2011Fertility and sterilitycited by 12

PMID 21550044PMC3129384DOI 10.1016/j.fertnstert.2011.04.008PUB-21550044

Rights unknown
Source link

Indexing hint: Meta-analysis (pooled) · 2006

Adjuvant goserelin in pre-menopausal patients with early breast cancer: Results from the ZIPP study.

Baum et al. 2006European journal of cancer (Oxford, England : 1990)cited by 67

PMID 16545560DOI 10.1016/j.ejca.2005.12.013PUB-16545560

Full text at the publisher
Publisher page

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedZong X, Yu Y, Chen W, Zong W, Yang H, Chen X. Ovarian reserve in premenopausal women with breast cancer. Breast. 2022 Aug;64:143-150. doi: 10.1016/j.breast.2022.05.009. Epub 2022 Jun 2. PMID 35691250

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 49 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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