Skip to content

Trial · Interventional

CompletedPhase 3Results postedRegistry data

S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer

NCTNCT00068601 (opens ClinicalTrials.gov in a new tab)Other idCDR0000327758Other idS0230Other idCALGB-40401Other idIBCSG-34-05
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
257 participants (actual)
Sponsor
SWOG Cancer Research Network · Network
Design
Randomized · Open label (no masking)
Countries
6 countries

Australia, Belgium, Hungary, Italy, New Zealand, Switzerland

Start
Oct 2003
Primary completion
Jan 2014
Completion
Sept 2016
First posted
11 Sept 2003 (estimated)
Last update posted
30 Dec 2019
Conditions
Breast Cancer · Infertility · Menopausal Symptoms

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200520102015
  1. Ph 3

    S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer

    NCT00068601

    Oct 2003 to Sept 2016

Registry summary

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

RATIONALE: Goserelin blocks hormone production in the ovaries. It is not yet known whether ovarian suppression using goserelin will prevent ovarian failure (early menopause) in women receiving chemotherapy for breast cancer. PURPOSE: This randomized phase III trial is studying how well giving goserelin together with chemotherapy works compared with chemotherapy alone in preventing early menopause in women with stage I, stage II, or stage IIIA breast cancer.

Interventions

  • cyclophosphamideDrug
  • goserelin acetateDrug

Arms2

  • Active comparator

    Standard Chemotherapy

    Patients receive cyclophosphamide-containing chemotherapy alone.

  • Experimental

    Chemotherapy Plus Goserelin

    Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Rate of Premature Ovarian Failure at 2 Years

    Time frame · 2 years

    Registry description

    Ovarian failure at two years is defined as amenorrhea (absence of menstrual bleeding) for the preceding six months AND the presence of follicle-stimulating hormone (FSH) in the post-menopausal range.

Secondary outcomes(2)

  1. Rate of Ovarian Dysfunction at 2 Years

    Time frame · 2 years

    Registry description

    Ovarian dysfunction is defined as amenorrhea for the preceding three months and the presence of FSH, estradiol and/or inhibin B levels in the postmenopausal range.

  2. Rate of Ovarian Dysfunction at 1 Year

    Time frame · 1 year

    Registry description

    Ovarian dysfunction is defined as amenorrhea for the preceding three months and the presence of FSH, estradiol and/or inhibin B levels in the postmenopausal range.

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· 2 years

Rate of Premature Ovarian Failure at 2 Years

GroupValue (Participants)
Standard Chemotherapy15
Chemotherapy Plus Goserelin5
Secondary and other outcome results(3)
Secondary outcomeCount of participants· 2 years

Rate of Ovarian Dysfunction at 2 Years

GroupValue (Participants)
Standard Chemotherapy22
Chemotherapy Plus Goserelin9
Other pre specified outcome· 1 and 2 years

Ovarian Reserve at 1 and 2 Years

GroupValue
Secondary outcomeCount of participants· 1 year

Rate of Ovarian Dysfunction at 1 Year

GroupValue (Participants)
Standard Chemotherapy28
Chemotherapy Plus Goserelin18

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Standard ChemotherapyPatients receive cyclophosphamide-containing chemotherapy alone. cyclophosphamide: Part of planned chemotherapy regimen–0 / 11170 / 111
Chemotherapy Plus GoserelinPatients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Part of planned chemotherapy regimen. goserelin acetate: Given subcutaneously–1 / 10373 / 103

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

Studies1

Studies that cite this trial.

Studies with results

1 study 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)

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
DISEASE CHARACTERISTICS: * Histologically confirmed invasive breast cancer * Stage I-IIIA * Operable disease * Bilateral synchronous invasive breast cancer allowed provided primary tumors were diagnosed no more than 1 month apart and both tumors are hormone receptor negative * Must be planning to receive 3-8 months of a preoperative or postoperative chemotherapy regimen containing alkylating agents (anthracyclines or non-anthracyclines), meeting 1 of the following criteria: * 3-month/4-course anthracycline-based regimen * 6- to 8-month/course anthracycline-based regimen * 6- to 8-month/course non-anthracycline-based regimen * Hormone receptor status: * Estrogen receptor negative * Progesterone receptor negative PATIENT CHARACTERISTICS: Age * 18 to 49 Sex * Female Menopausal status * Premenopausal Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Not pregnant or nursing * Fertile patients must use effective barrier contraception * No other prior malignancy except adequately treated basal cell or squamous cell skin cancer or any in situ cancer from which the patient has been disease-free for at least 5 years after treatment with curative intent PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * No prior cytotoxic chemotherapy Endocrine therapy * No other concurrent hormonal therapy Radiotherapy * Concurrent radiotherapy to the breast, chest wall, or lymph nodes allowed Surgery * See Disease Characteristics Other * Concurrent participation in other therapeutic clinical trials, including SWOG-S0221, allowed

PepBank is a research reference. Talk to a doctor before you use any peptide.