Breast Cancer Patients in PremenopausalPhase 2/3NCT02132000
Efficacy and Tolerability of Toremifene or Tamoxifen Therapy in Premenopausal Estrogen and Progesterone Receptor Positive Breast Cancer Patients
A Phase 2/3 study testing toremifene or tamoxifen in people with Breast Cancer Patients in Premenopausal and Estrogen and/or Progesterone Receptor Positive, run by Fengxi Su at 1 site in China.
Trial summary
In premenopausal women, endocrine adjuvant therapy for breast cancer primarily consists of tamoxifen alone or with ovarian suppressive strategies. Toremifene is a chlorinated derivative of tamoxifen, but with a superior risk-benefit profile. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancer Patients in Premenopausal, Estrogen and/or Progesterone Receptor Positive
- What is being tested?
- toremifene or tamoxifen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,036 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to May 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of Breast cancer
- Received standard treatment (chemotherapy, operation, or radiotherapy)
- premenopausal
- estrogen and/or progesterone receptor positive
Who cannot join
- Metastatic tumors
- During pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Breast cancer center of Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510000
Yaping yang, master, 0086-020-34071145, yypapple1225@163.com
Fengxi Su, Doctor
About this study
In premenopausal women, endocrine adjuvant therapy for breast cancer primarily consists of tamoxifen alone or with ovarian suppressive strategies. Toremifene is a chlorinated derivative of tamoxifen, but with a superior risk-benefit profile. In this trial, we sought to compare the efficacy and tolerability of toremifene and tamoxifen therapy in premenopausal patients with operable,estrogen and/or progesterone receptor positive breast cancer patients.
- Being tested
- toremifene or tamoxifen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
toremifene or tamoxifenDrug
| Study group | Role | What they receive |
|---|---|---|
| tamoxifen | Active comparator | tamoxifen,20mg/day Receives: Drug: toremifene or tamoxifen |
| toremifene | Experimental | toremifene,60mg/day Receives: Drug: toremifene or tamoxifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival outcomes: disease free survival
Measured: up to 5 years
5-year overall survival
Measured: up to 5 years
Secondary outcomes (2)
side effects effects of therapies
the primary safety measures are Hepatic function and blood lipid
Measured: Follow-up period,up to 5 years
Incidence of adverse events
Adverse events including hot flashes, irregular menses and others.
Measured: follow-up period, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Patients in PremenopausalStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,036 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fengxi Su
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fengxi Su, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132000
- Sponsor's protocol ID
- BCSCO002
- Status last verified
- May 2014
- First submitted
- 30 Apr 2014
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Toremifene or Tamoxifen Therapy in Premenopausal Estrogen and Progesterone Receptor Positive Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02132000
- Acronym / sponsor ID
- BCSCO002
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,036 participants (estimated)
- Lead sponsor
- Fengxi SuUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 6 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In premenopausal women, endocrine adjuvant therapy for breast cancer primarily consists of tamoxifen alone or with ovarian suppressive strategies. Toremifene is a chlorinated derivative of tamoxifen, but with a superior risk-benefit profile. In this trial, we sought to compare the efficacy and tolerability of toremifene and tamoxifen therapy in premenopausal patients with operable,estrogen and/or progesterone receptor positive breast cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tamoxifen | Active comparator | Drug: toremifene or tamoxifentamoxifen,20mg/day |
| toremifene | Experimental | Drug: toremifene or tamoxifentoremifene,60mg/day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of Breast cancer
- Received standard treatment (chemotherapy, operation, or radiotherapy)
- premenopausal
- estrogen and/or progesterone receptor positive
Key exclusion criteria (2 listed)
- Metastatic tumors
- During pregnancy or lactation
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 |
|---|---|---|
| toremifene or tamoxifen | Drug | tamoxifen, toremifene |
Primary outcome
survival outcomes: disease free survival
Time frame: up to 5 years
5-year overall survival
Time frame: up to 5 years
2 secondary outcomes
side effects effects of therapies
Time frame: Follow-up period,up to 5 years
Incidence of adverse events
Time frame: follow-up period, up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
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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.
Breast cancer center of Sun Yat-sen Memorial Hospital
Guangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing toremifene or tamoxifen in people with Breast Cancer Patients in Premenopausal and Estrogen and/or Progesterone Receptor Positive, run by Fengxi Su at 1 site in China.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival outcomes: disease free survival (time frame: up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2014.