Breast CancerPhase 3NCT00201851
Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
A Phase 3 study testing Tamoxifen and Surgery: Oophorectomy in people with Breast Cancer, run by International Breast Cancer Research Foundation at 9 sites in 3 countries.
Trial summary
This trial tests surgical oophorectomy (removal of ovaries) plus Tamoxifen, done at different times in the menstrual cycle, as adjuvant therapy for invasive breast cancer in 510 premenopausal women with Hormone Receptor-positive Breast Cancer. This study is recruiting at hospitals in Philippines, Vietnam, and Morocco. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tamoxifen and Surgery: Oophorectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 740 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Jan 2004to May 2013
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Open for accrual in Asia only
- Female age 18-50,
- premenopausal with regular cycles (>25-35 in length)
- fine-needle aspiration diagnosis
- Stage II-IIIA hormone receptor positive invasive breast cancer
- No prior radiation or chemotherapy
- Must be surgical candidate for bilateral oophorectomy
Who cannot join
None listed.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Philippines5 sites
Vicente Soto Memorial Medical Center
Cebu
East Avenue Medical Center
Manila
Philippine General Hospital
Manila
Rizal
Manila
Santo Toma Hospital
Manila
Vietnam3 sites
Danang General
Da Nang
Hospital K, National Cancer Institute
Hanoi
Hue Central
Huế
About this study
Official title: Phase III Randomized Study of Immediate Versus Luteal Phase Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-positive Breast Cancer
This trial tests surgical oophorectomy (removal of ovaries) plus Tamoxifen, done at different times in the menstrual cycle, as adjuvant therapy for invasive breast cancer in 510 premenopausal women with Hormone Receptor-positive Breast Cancer. This study is recruiting at hospitals in Philippines, Vietnam, and Morocco.
- Conditions
- Breast Cancer
- Being tested
- Tamoxifen, Surgery: Oophorectomy
- Keywords
- Asian, Premenopausal, Women, Oophorectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamoxifenDrug
Also called Nolvadex®
20 mg po daily x 5 years
Surgery: OophorectomyProcedure or surgery
Also called ovary removal surgery
Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)
| Study group | Role | What they receive |
|---|---|---|
| Immediate surgery | Active comparator | Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen Receives: Drug: Tamoxifen; Procedure: Surgery: Oophorectomy |
| Scheduled surgery | Experimental | Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen Receives: Drug: Tamoxifen; Procedure: Surgery: Oophorectomy |
| Immediate Surgery - nonrandomized | Other | Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization Receives: Drug: Tamoxifen; Procedure: Surgery: Oophorectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free Survival
5-year disease-free survival
Measured: two- to three-year accrual and initial two or more years of follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionDec 2011
- Study completionMay 2013
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 740 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Breast Cancer Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard R. Love, M.D., Principal investigator, International Breast Cancer Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201851
- Sponsor's protocol ID
- OSU-0483
- Status last verified
- Apr 2015
- First submitted
- 12 Sep 2005
- Last updated
- 29 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hade EM, Young GS, Love RR. Follow up after sample size re-estimation in a breast cancer randomized trial for disease-free survival. Trials. 2019 Aug 23;20(1):527. doi: 10.1186/s13063-019-3632-9.
PubMed 31443726
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Study of Immediate Versus Luteal Phase Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-positive Breast Cancer
- ClinicalTrials.gov ID
- NCT00201851
- Acronym / sponsor ID
- OSU-0483
- Conditions
- Breast Cancer
- Keywords
- Asian, Premenopausal, Women, Oophorectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 740 participants (actual)
- Lead sponsor
- International Breast Cancer Research FoundationUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Dec 2011 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 29 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial tests surgical oophorectomy (removal of ovaries) plus Tamoxifen, done at different times in the menstrual cycle, as adjuvant therapy for invasive breast cancer in 510 premenopausal women with Hormone Receptor-positive Breast Cancer. This study is recruiting at hospitals in Philippines, Vietnam, and Morocco.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immediate surgery | Active comparator | Drug: Tamoxifen, Procedure: Surgery: OophorectomyPatient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen |
| Scheduled surgery | Experimental | Drug: Tamoxifen, Procedure: Surgery: OophorectomyPatient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen |
| Immediate Surgery - nonrandomized | Other | Drug: Tamoxifen, Procedure: Surgery: OophorectomyPatient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Open for accrual in Asia only
- Female age 18-50,
- premenopausal with regular cycles (>25-35 in length)
- fine-needle aspiration diagnosis
- Stage II-IIIA hormone receptor positive invasive breast cancer
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| TamoxifenAlso: Nolvadex®20 mg po daily x 5 years | Drug | Immediate Surgery - nonrandomized, Immediate surgery, Scheduled surgery |
| Surgery: OophorectomyAlso: ovary removal surgeryGroup A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c) | Procedure or surgery | Immediate Surgery - nonrandomized, Immediate surgery, Scheduled surgery |
Primary outcome
Disease-free Survival
Time frame: two- to three-year accrual and initial two or more years of follow-up period
5-year disease-free survival
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31443726Hade EM, Young GS, Love RR. Follow up after sample size re-estimation in a breast cancer randomized trial for disease-free survival. Trials. 2019 Aug 23;20(1):527. doi: 10.1186/s13063-019-3632-9.
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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.
Richard R. Love, M.D. principal investigator
International Breast Cancer Research Foundation
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tamoxifen and Surgery: Oophorectomy in people with Breast Cancer, run by International Breast Cancer Research Foundation at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. 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 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Philippines, Vietnam, Morocco. 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 29 Apr 2015). 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?
Disease-free Survival (time frame: two- to three-year accrual and initial two or more years of follow-up period). 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 NCT00201851, 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 29 Apr 2015.