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Trial · Interventional

WithdrawnPhase 3Registry data

Protection of Ovarian Function With Goserelin Acetate in Premenopausal Early Breast Cancer Patients With Chemotherapy

Short name PROOF

NCTNCT00888082 (opens ClinicalTrials.gov in a new tab)Other idD8664L00012
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Withdrawn
Phase
Phase 3
Enrollment
102 participants (estimated)
Sponsor
AstraZeneca · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Turkey (Türkiye)

Start
Not stated
Primary completion
Apr 2012 (estimated)
Completion
Apr 2012 (estimated)
First posted
24 Apr 2009 (estimated)
Last update posted
10 Dec 2010 (estimated)
Conditions
Breast Cancer · Ovarian Function

Registry summary

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

Primary objective of this study is to determine the effectiveness of goserelin acetate (Zoladex) in preserving ovarian function in premenopausal women undergoing adjuvant chemotherapy for primary invasive breast cancer by documenting persistence or resumption of regular menses via menstrual history, serum FSH and E2 measurements. The secondary objectives of this study are as follows: To investigate the impact of treatment with chemotherapy with or without goserelin acetate (i.e. impact of the expectation of ovarian function preservation) on participants' quality of life (QOL) by FACT-ES scale, and to compare safety and tolerability of study drugs in two treatment groups by evaluation of adverse events.

Interventions

  • Goserelin acetateDrug

Arms2

  • No intervention

    A

    Patients receiving only adjuvant chemotherapy

  • Experimental

    B

    Patient receiving goserelin acetate along with adjuvant chemotherapy

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. The ovarian function will be considered as regained, if E2 measurements return to premenopausal levels (equal to or above 20 pg/ml), FSH measurements return to premenopausal levels (less than or equal to 40 IU/L)

    Time frame · Each 3 months

  2. The ovarian function will be considered as regained, if menstrual bleeding is observed in two consecutive menstrual cycles

    Time frame · Each 3 months

Secondary outcomes(1)

  1. Quality of life (QOL) through-out the study measured by FACT-ES scale.

    Time frame · Each 3 months

Posted results

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

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

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

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Animal study · 1995

3 results

Luteinizing hormone-releasing hormone agonist inhibits cyclophosphamide-induced ovarian follicular depletion in rhesus monkeys.

Ataya et al. 1995Biology of reproductioncited by 179

PMID 7711205DOI 10.1095/biolreprod52.2.365PUB-07711205

Rights unknown3 results
Source linkSee results (3)

More studies

1 study on this page

Indexing hint: Clinical trial · 2006

Prevention of chemotherapy-induced menopause by temporary ovarian suppression with goserelin in young, early breast cancer patients.

Del Mastro et al. 2006Annals of oncology : official journal of the European Society for Medical Oncologycited by 65

PMID 16254024DOI 10.1093/annonc/mdj029PUB-16254024

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Pathologically confirmed invasive breast carcinoma * Candidates for adjuvant chemotherapy for primary breast cancer * Premenopausal, verified before chemotherapy is begun as satisfying both cyclic vaginal bleeding and appropriate hormone levels Exclusion Criteria: * Previous systemic chemotherapy * Pregnancy * Stage IV breast cancer

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