Breast CancerPhase 3NCT02097459
Prognostic Evaluation of Changing Endocrine Therapy in Women With Breast Cancer
A Phase 3 study testing Anastrozole, Tamoxifen and Toremifene in people with Breast Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
It suggests in the Guideline that the postmenopausal women with breast cancer who have taken selective estrogen receptor modulators (SERMs) therapy for 2-3 years could benefit from changing endocrine therapy to aromatase inhibitors (AIs). Read more about this study
- Who is it for?
- Ages 45 to 55 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Anastrozole, Tamoxifen and Toremifene
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Mar 2014to Mar 2024
- Phase
- Phase 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 45 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures.
- Age of at least 45 and at most 55 years.
- Performance status (Karnofsky-Index) >80%
- Steroid receptor (estrogen and progesterone) positive tumor (diagnosis according to hospital standard-procedures).
- No clinical evidence of local recurrence or distant metastases.
- Complete staging work-up within 3 months prior to registration. All patients must have (bilateral) mammography or breast MRI, chest X-ray; other tests may be performed as clinically indicated.
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- Patients have taken the SERMs as endocrine therapy for 2-4 years.
- Patients who have had amenorrhea for at least half a year.
- Life expectancy of at least 10 years, disregarding the diagnosis of cancer.
- Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution.
- Patients must be available for and compliant to treatment and follow-up.
- Patients registered on this trial must be treated and followed up at the participating center.
Who cannot join
- Known hypersensitivity reaction to the investigational compounds or incorporated substances.
- Hormone receptor-negative breast cancer.
- Local recurrence and/or metastasis of breast cancer.
- History of hysterectomy.
- Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration.
- History of osteoporosis and/or fractures due to osteoporosis.
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- Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix)
- Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled high risk arrhythmias
- Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study.
- Concurrent treatment with other experimental drugs or any other anti-cancer therapy.
- Males.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Qiang Sun, Doctor, 8610-69152700, birds90@163.com
About this study
Official title: Prognostic Evaluation of Changing Endocrine Therapy in Perimenopausal and Recently Postmenopausal Women With Early-stage Hormone Receptor-Positive Breast Cancer
It suggests in the Guideline that the postmenopausal women with breast cancer who have taken selective estrogen receptor modulators (SERMs) therapy for 2-3 years could benefit from changing endocrine therapy to aromatase inhibitors (AIs). This is a prospective, randomized and non-inferior trial to evaluate the prognosis of changing endocrine therapy from SERMs to AIs in perimenopausal and recently postmenopausal women with early-stage hormone receptor-positive breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Anastrozole, Tamoxifen, Toremifene
- Keywords
- Breast cancer, Endocrine therapy, Perimenopausal and recently postmenopausal patients, Early-stage hormone receptor-positive
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnastrozoleDrug
Also called Arimidex
TamoxifenDrug
ToremifeneDrug
Also called Fareston, Shu Rui
| Study group | Role | What they receive |
|---|---|---|
| Failed group | Experimental | Patients who have recurrence of menstruation after changing endocrine therapy to anastrozole and then go back to the original SERMs therapy. Receives: Drug: Anastrozole; Drug: Tamoxifen; Drug: Toremifene |
| Succeeded group | Experimental | Patients who have no recurrence of menstruation after changing endocrine therapy and then go on with anastrozole therapy. Receives: Drug: Anastrozole |
| No chang group | Active comparator | Patients who don't change the endocrine therapy and go on with the original tamoxifen or toremifene therapy. Receives: Drug: Tamoxifen; Drug: Toremifene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Measured: 10 years
Overall Survival
Measured: 10 years
Secondary outcomes (2)
Disease Free Survival
Measured: 5 years
Overall Survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiang SUN, Peking Union Medical College Hospital
- Investigators
- Qiang Sun, Doctor, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097459
- Sponsor's protocol ID
- PUMCH-BREAST-AI
- Status last verified
- May 2016
- First submitted
- 19 Mar 2014
- Last updated
- 25 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Evaluation of Changing Endocrine Therapy in Perimenopausal and Recently Postmenopausal Women With Early-stage Hormone Receptor-Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT02097459
- Acronym / sponsor ID
- PUMCH-BREAST-AI
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Endocrine therapy, Perimenopausal and recently postmenopausal patients, Early-stage hormone receptor-positive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2024 (estimated)
- First posted
- 27 Mar 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.
It suggests in the Guideline that the postmenopausal women with breast cancer who have taken selective estrogen receptor modulators (SERMs) therapy for 2-3 years could benefit from changing endocrine therapy to aromatase inhibitors (AIs). This is a prospective, randomized and non-inferior trial to evaluate the prognosis of changing endocrine therapy from SERMs to AIs in perimenopausal and recently postmenopausal women with early-stage hormone receptor-positive breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Failed group | Experimental | Drug: Anastrozole, Drug: Tamoxifen, Drug: ToremifenePatients who have recurrence of menstruation after changing endocrine therapy to anastrozole and then go back to the original SERMs therapy. |
| Succeeded group | Experimental | Drug: AnastrozolePatients who have no recurrence of menstruation after changing endocrine therapy and then go on with anastrozole therapy. |
| No chang group | Active comparator | Drug: Tamoxifen, Drug: ToremifenePatients who don't change the endocrine therapy and go on with the original tamoxifen or toremifene therapy. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures.
- Age of at least 45 and at most 55 years.
- Performance status (Karnofsky-Index) >80%
- Steroid receptor (estrogen and progesterone) positive tumor (diagnosis according to hospital standard-procedures).
- No clinical evidence of local recurrence or distant metastases.
Key exclusion criteria (11 listed)
- Known hypersensitivity reaction to the investigational compounds or incorporated substances.
- Hormone receptor-negative breast cancer.
- Local recurrence and/or metastasis of breast cancer.
- History of hysterectomy.
- Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration.
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 |
|---|---|---|
| AnastrozoleAlso: Arimidex | Drug | Failed group, Succeeded group |
| Tamoxifen | Drug | Failed group, No chang group |
| ToremifeneAlso: Fareston, Shu Rui | Drug | Failed group, No chang group |
Primary outcome
Disease free survival
Time frame: 10 years
Overall Survival
Time frame: 10 years
2 secondary outcomes
Disease Free Survival
Time frame: 5 years
Overall Survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2016.
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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.
Qiang Sun, Doctor study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anastrozole, Tamoxifen and Toremifene in people with Breast Cancer, run by Peking Union Medical College Hospital 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 12 inclusion and 11 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 25 May 2016. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiang Sun, Doctor (8610-69152700, birds90@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: 10 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 25 May 2016.