Breast CancerPhase 3NCT00068601
S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer
A Phase 3 study testing cyclophosphamide and goserelin acetate in people with Breast Cancer and Infertility, run by SWOG Cancer Research Network at 34 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Breast Cancer, Infertility, Menopausal Symptoms
- What is being tested?
- cyclophosphamide and goserelin acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 34 sitesin 6 countries
- Study dates
- Oct 2003to Sep 2016
- 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
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
Trial locations and contacts
34 sites in 6 countries.
34 sites in 6 countries
Australia14 sites
Royal Adelaide Hospital Cancer Centre
Adelaide, South Australia, 5000
Ballarat Oncology and Haematology Services
Ballarat, Victoria, 3350
Flinders Medical Centre
Bedford Park, South Australia, 5042
Box Hill Hospital
Box Hill, Victoria, 3128
Monash Medical Center - Clayton Campus
Clayton, Victoria, 3168
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 3002
Maroondah Hospital
East Ringwood, Victoria, 3135
St. Vincent's Hospital - Melbourne
Fitzroy, Victoria, 3065
Royal Hobart Hospital
Hobart, Tasmania, 7000
Mater Hospital - North Sydney
North Sydney, New South Wales, 2060
Royal Melbourne Hospital
Parkville, Victoria, 3050
Royal Perth Hospital
Perth, Western Australia, 6000
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Newcastle Mater Misericordiae Hospital
Waratah, New South Wales, 2298
Switzerland7 sites
Oncology Institute of Southern Switzerland
Bellinzona, CH-6500
Inselspital Bern
Bern, CH-3010
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
Oncology Institute of Southern Switzerland - Locarno
Locarno, CH-6601
Oncology Institute of Southern Switzerland - Lugano
Lugano, CH-6900
Oncology Institute of Southern Switzerland - Mendrisio
Mendrisio, CH-6850
Regionalspital
Thun, 3600
Belgium6 sites
Centre Hospitalier Hutois
Huy, 4500
U.Z. Gasthuisberg
Leuven, B-3000
Centre Hospitalier Regional de la Citadelle
Liège, 4000
CHU Liege - Domaine Universitaire du Sart Tilman
Liège, B-4000
AZ Damiaan
Ostend, 8400
Centre Hospitalier Peltzer-La Tourelle
Verviers, B-4800
Italy5 sites
Ospedali Riuniti di Bergamo
Bergamo, 24100
Ospedale degli Infermi - ASL 12
Biella, 13900
Ospedale Civile Ramazzini
Carpi, 41012
Ospedale Alessandro Manzoni
Lecco, 23900
European Institute of Oncology
Milan, 20141
About this study
Official title: Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer
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.
Read the detailed description
OBJECTIVES:
Primary
- Compare the rate of premature ovarian failure in women with stage I-IIIA hormone receptor-negative breast cancer treated with chemotherapy with vs without goserelin.
Secondary
- Compare the rate of ovarian dysfunction in patients treated with these regimens.
- Compare ovarian reserve in patients treated with these regimens.
- Describe the pregnancy rates in patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are stratified according to age (under 40 vs 40 to 49) and planned chemotherapy regimen (3- to 4-month/course anthracycline-based vs 6- to 8-month/course anthracycline-based vs 3- to 4-month/course non-anthracycline-based vs 6- to 8-month/course non-anthracycline-based). Patients are randomized to 1 of 2 treatment arms.
- Arm 1: Patients receive cyclophosphamide-containing chemotherapy alone. Patients are followed at 1, 2, and 5 years.
- Arm 2: 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.
PROJECTED ACCRUAL: A total of 416 patients (208 per treatment arm) will be accrued for this study within 3 years.
- Conditions
- Breast Cancer, Infertility, Menopausal Symptoms
- Being tested
- cyclophosphamide, goserelin acetate
- Keywords
- infertility, menopausal symptoms, stage II breast cancer, stage IIIA breast cancer, stage IA breast cancer, stage IB breast cancer, estrogen receptor-negative breast cancer, progesterone receptor-negative breast cancer
- Medical subject headings
- Breast Neoplasms, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclophosphamideDrug
Part of planned chemotherapy regimen
goserelin acetateDrug
Given subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Standard Chemotherapy | Active comparator | Patients receive cyclophosphamide-containing chemotherapy alone. Receives: Drug: cyclophosphamide |
| Chemotherapy Plus Goserelin | Experimental | 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. Receives: Drug: cyclophosphamide; Drug: goserelin acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Premature Ovarian Failure at 2 Years
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.
Measured: 2 years
Secondary outcomes (2)
Rate of Ovarian Dysfunction at 2 Years
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.
Measured: 2 years
Rate of Ovarian Dysfunction at 1 Year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2003 (estimated)
- Study startOct 2003
- Primary completionJan 2014
- Study completionSep 2016
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 (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), Cancer and Leukemia Group B, Eastern Cooperative Oncology Group, ETOP IBCSG Partners Foundation
- Responsible party
- Sponsor
- Investigators
- Halle C Moore, MD, Principal investigator, The Cleveland ClinicKathy S. Albain, MD, Study chair, Loyola UniversitySilvana Martino, DO, Study chair, Saint John's Cancer InstituteAnn H. Partridge, MD, MPH, Study chair, Dana-Farber Cancer InstituteLori J. Goldstein, MD, Study chair, Fox Chase Cancer CenterKelly-Anne Phillips, Study chair, Peter MacCallum Cancer Centre, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00068601
- Sponsor's protocol ID
- CDR0000327758
- Other IDs
- S0230, CALGB-40401, IBCSG-34-05, U10CA037429
- Status last verified
- Dec 2019
- First submitted
- 10 Sep 2003
- Last updated
- 30 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Moore HC, Unger JM, Phillips KA, Boyle F, Hitre E, Porter D, Francis PA, Goldstein LJ, Gomez HL, Vallejos CS, Partridge AH, Dakhil SR, Garcia AA, Gralow J, Lombard JM, Forbes JF, Martino S, Barlow WE, Fabian CJ, Minasian L, Meyskens FL Jr, Gelber RD, Hortobagyi GN, Albain KS; POEMS/S0230 Investigators. Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy. N Engl J Med. 2015 Mar 5;372(10):923-32. doi: 10.1056/NEJMoa1413204.
PubMed 25738668
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT00068601
- Acronym / sponsor ID
- CDR0000327758
- Conditions
- Breast Cancer, Infertility, Menopausal Symptoms
- Keywords
- infertility, menopausal symptoms, stage II breast cancer, stage IIIA breast cancer, stage IA breast cancer, stage IB breast cancer, estrogen receptor-negative breast cancer, progesterone receptor-negative breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI), Cancer and Leukemia Group B, Eastern Cooperative Oncology Group, ETOP IBCSG Partners Foundation
- Study start
- Oct 2003
- Primary completion
- Jan 2014 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 11 Sep 2003 (estimated)
- Results
- Posted 4 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
Primary
- Compare the rate of premature ovarian failure in women with stage I-IIIA hormone receptor-negative breast cancer treated with chemotherapy with vs without goserelin.
Secondary
- Compare the rate of ovarian dysfunction in patients treated with these regimens.
- Compare ovarian reserve in patients treated with these regimens.
- Describe the pregnancy rates in patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are stratified according to age (under 40 vs 40 to 49) and planned chemotherapy regimen (3- to 4-month/course anthracycline-based vs 6- to 8-month/course anthracycline-based vs 3- to 4-month/course non-anthracycline-based vs 6- to 8-month/course non-anthracycline-based). Patients are randomized to 1 of 2 treatment arms.
- Arm 1: Patients receive cyclophosphamide-containing chemotherapy alone. Patients are followed at 1, 2, and 5 years.
- Arm 2: 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.
PROJECTED ACCRUAL: A total of 416 patients (208 per treatment arm) will be accrued for this study within 3 years.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Chemotherapy | Active comparator | Drug: cyclophosphamidePatients receive cyclophosphamide-containing chemotherapy alone. |
| Chemotherapy Plus Goserelin | Experimental | Drug: cyclophosphamide, Drug: goserelin acetatePatients 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| cyclophosphamidePart of planned chemotherapy regimen | Drug | Chemotherapy Plus Goserelin, Standard Chemotherapy |
| goserelin acetateGiven subcutaneously | Drug | Chemotherapy Plus Goserelin |
Primary outcome
Rate of Premature Ovarian Failure at 2 Years
Time frame: 2 years
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.
2 secondary outcomes
Rate of Ovarian Dysfunction at 2 Years
Time frame: 2 years
Rate of Ovarian Dysfunction at 1 Year
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25738668Moore HC, Unger JM, Phillips KA, Boyle F, Hitre E, Porter D, Francis PA, Goldstein LJ, Gomez HL, Vallejos CS, Partridge AH, Dakhil SR, Garcia AA, Gralow J, Lombard JM, Forbes JF, Martino S, Barlow WE, Fabian CJ, Minasian L, Meyskens FL Jr, Gelber RD, Hortobagyi GN, Albain KS; POEMS/S0230 Investigators. Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy. N Engl J Med. 2015 Mar 5;372(10):923-32. doi: 10.1056/NEJMoa1413204.
- Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.Link provided by the sponsor.
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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.
Halle C Moore, MD principal investigator
The Cleveland Clinic
Kathy S. Albain, MD study chair
Loyola University
Silvana Martino, DO study chair
Saint John's Cancer Institute
34 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cyclophosphamide and goserelin acetate in people with Breast Cancer and Infertility, run by SWOG Cancer Research Network at 34 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Australia, Switzerland, Belgium, Italy, Hungary and 1 more country. 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 4 Apr 2017). 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?
Rate of Premature Ovarian Failure at 2 Years (time frame: 2 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 NCT00068601, which also lists 1 linked publication.
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 30 Dec 2019.