Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00068601




Registration number
NCT00068601
Ethics application status
Date submitted
10/09/2003
Date registered
11/09/2003
Date last updated
30/12/2019

Titles & IDs
Public title
S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer
Scientific title
Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer
Secondary ID [1] 0 0
S0230
Secondary ID [2] 0 0
CDR0000327758
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Infertility 0 0
Menopausal Symptoms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - goserelin acetate

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.


Treatment: Drugs: cyclophosphamide
Part of planned chemotherapy regimen

Treatment: Drugs: goserelin acetate
Given subcutaneously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of Premature Ovarian Failure at 2 Years
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Rate of Ovarian Dysfunction at 2 Years
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Rate of Ovarian Dysfunction at 1 Year
Timepoint [2] 0 0
1 year

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
49 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Supportive Care
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2016
Sample size
Target
Accrual to date
Final
257
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Mater Hospital - North Sydney - North Sydney
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [3] 0 0
Newcastle Mater Misericordiae Hospital - Waratah
Recruitment hospital [4] 0 0
Royal Adelaide Hospital Cancer Centre - Adelaide
Recruitment hospital [5] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [6] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [7] 0 0
Ballarat Oncology and Haematology Services - Ballarat
Recruitment hospital [8] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [9] 0 0
Monash Medical Center - Clayton Campus - Clayton
Recruitment hospital [10] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [11] 0 0
Maroondah Hospital - East Ringwood
Recruitment hospital [12] 0 0
St. Vincent's Hospital - Melbourne - Fitzroy
Recruitment hospital [13] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [14] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2060 - North Sydney
Recruitment postcode(s) [2] 0 0
2065 - St. Leonards
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
7000 - Hobart
Recruitment postcode(s) [7] 0 0
3350 - Ballarat
Recruitment postcode(s) [8] 0 0
3128 - Box Hill
Recruitment postcode(s) [9] 0 0
3168 - Clayton
Recruitment postcode(s) [10] 0 0
3002 - East Melbourne
Recruitment postcode(s) [11] 0 0
3135 - East Ringwood
Recruitment postcode(s) [12] 0 0
3065 - Fitzroy
Recruitment postcode(s) [13] 0 0
3050 - Parkville
Recruitment postcode(s) [14] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Huy
Country [2] 0 0
Belgium
State/province [2] 0 0
Leuven
Country [3] 0 0
Belgium
State/province [3] 0 0
Liege
Country [4] 0 0
Belgium
State/province [4] 0 0
Oostende
Country [5] 0 0
Belgium
State/province [5] 0 0
Verviers
Country [6] 0 0
Hungary
State/province [6] 0 0
Budapest
Country [7] 0 0
Italy
State/province [7] 0 0
Bergamo
Country [8] 0 0
Italy
State/province [8] 0 0
Biella
Country [9] 0 0
Italy
State/province [9] 0 0
Carpi
Country [10] 0 0
Italy
State/province [10] 0 0
Lecco
Country [11] 0 0
Italy
State/province [11] 0 0
Milano
Country [12] 0 0
New Zealand
State/province [12] 0 0
Auckland
Country [13] 0 0
Switzerland
State/province [13] 0 0
Bellinzona
Country [14] 0 0
Switzerland
State/province [14] 0 0
Bern
Country [15] 0 0
Switzerland
State/province [15] 0 0
Lausanne
Country [16] 0 0
Switzerland
State/province [16] 0 0
Locarno
Country [17] 0 0
Switzerland
State/province [17] 0 0
Lugano
Country [18] 0 0
Switzerland
State/province [18] 0 0
Mendrisio
Country [19] 0 0
Switzerland
State/province [19] 0 0
Thun

Funding & Sponsors
Primary sponsor type
Other
Name
SWOG Cancer Research Network
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Cancer and Leukemia Group B
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Eastern Cooperative Oncology Group
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
ETOP IBCSG Partners Foundation
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00068601
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Halle C Moore, MD
Address 0 0
The Cleveland Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00068601