Breast CancerPhase 4TTOSNCT02344940
Safety of Toremifene and Tamoxifen Therapy in Premenopausal Patients With Operable Breast Cancer
A Phase 4 study testing Toremifene and Tamoxifen in people with Breast Cancer, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
To compare the safety of toremifene and tamoxifen therapy in premenopausal patients with operable breast cancer by monitoring gynecological abnormality,blood lipid level,hepatic abnormality,estrogen level and perimenopausal symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Toremifene and Tamoxifen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Aug 2018
- Phase
- Phase 4
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged ≥18 years, premenopausal
- Histologically confirmed invasive breast cancer by core needle biopsy, hormonal receptor positive, defined as estrogen receptor(ER)/progesterone receptor(PR) positive
- Patients must have received standard local therapy: normalized modified radical mastectomy or breast conserving surgery with negative margin and post-surgical radiotherapy. Patient should completed adjuvant therapy according to conditions, including adjuvant radiotherapy, neoadjuvant or adjuvant chemotherapy.
- Leukocyte ≥ 3*109/L; Platelets ≥ 75*109/L; Serum glutamate oxaloacetate(AST/SGOT) or serum glutamic-pyruvic transaminase(ALT/SGPT) <2.5 times of upper limit of normal (UNL) range Serum creatinine/blood urea nitrogen(BUN) ≤ upper limit of normal (UNL) range; Written informed consent according to the local ethics committee requirements.
- Has Eastern Cooperative Oncology Group(ECOG) Performance Score 0-2;
Who cannot join
- Histologically confirmed hormonal receptor negative.
- Have received neoadjuvant/adjuvant endocrine therapy.
- With metastatic tumor.
- Family history of endometrial cancer or ovarian cancer or any other kind of gynecological malignant tumor.
- Have already been detected of ovarian abnormality or endometrial thickening by transvaginal ultrasound.
- With any of complications that will increase sex hormone level: pituitary adenoma，ovarian tumor, thymic cancer，etc.
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- With any of complications that will decrease sex hormone level:hyperthyroidism，hypothyroidism，liver cirrhosis，severe malnutrition，Turner's syndrome，sex hormone synthetase deficiency, intracranial tumor, pituitary atrophy, etc.
- Ovarian ablation or suppression
- With severe non-malignant co-morbidity that will influence long-term follow up.
- With severe hepatic dysfunction, Child-Pugh C.
- With severe cardiac dysfunction, New York Heart Association (NYHA) grading III or worse.
- Known severe hypersensitivity to any drugs in this study;
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Safety of Toremifene and Tamoxifen Therapy in Premenopausal Patients With Operable Breast Cancer: A Randomized, Controlled, Prospective, Observational Study
To compare the safety of toremifene and tamoxifen therapy in premenopausal patients with operable breast cancer by monitoring gynecological abnormality,blood lipid level,hepatic abnormality,estrogen level and perimenopausal symptoms.
- Conditions
- Breast Cancer
- Being tested
- Toremifene, Tamoxifen
- Keywords
- operable, premenopausal, endocrine therapy, safety, tamoxifen, toremifene
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToremifeneDrug
Also called Fareston
patients will take toremifene 60 mg qd.
TamoxifenDrug
patients will take tamoxifen 10 mg bid.
| Study group | Role | What they receive |
|---|---|---|
| toremifene | Experimental | patients who will be treated with toremifene. Receives: Drug: Toremifene |
| tamoxifen | Active comparator | patients who will be treated with tamoxifen. Receives: Drug: Tamoxifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of ovarian cyst
Ovarian cyst is defined as a purely liquid-filled structure that was equal to or exceeded 2 cm in its largest diameter detected by transvaginal ultrasonography.Participants will be required to receive transvaginal ultrasonography every 3 months.
Measured: participants will be followed during the first year of endocrine therapy
Secondary outcomes (6)
incidence of endometrial thickening
Endometrial thickness as measured with transvaginal ultrasonography is equal to or exceeded 8mm.Participants will be required to receive transvaginal ultrasonography every 3 months.
Measured: participants will be followed during the first year of endocrine therapy
change of female hormones
Change of follicle stimulating hormone(FSH),luteinizing hormone(LH),estradiol(E2) as measured every 3 months
Measured: participants will be followed during the first year of endocrine therapy
change of blood lipid
Change of blood lipid as measured every 3 months
Measured: participants will be followed during the first year of endocrine therapy
change of liver function
change of blood lipid as measured every 3 months
Measured: participants will be followed during the first year of endocrine therapy
incidence of fatty liver
Incidence of fatty liver as examined by liver ultrasound every 3 months.
Measured: participants will be followed during the first year of endocrine therapy
change of Kupperman index
change of Kupperman index as measured every 3 months.
Measured: participants will be followed during the first year of endocrine therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 Shanghai Jiao Tong University School of MedicineThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kunwei Shen, Shanghai Jiao Tong University School of Medicine
- Investigators
- Kunwei Shen, Professor, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344940
- Sponsor's protocol ID
- RJBC1401
- Acronym
- TTOS
- Status last verified
- Sep 2019
- First submitted
- 5 Jan 2015
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hong J, Huang J, Shen L, Zhu S, Gao W, Wu J, Huang O, He J, Zhu L, Chen W, Li Y, Chen X, Shen K. A prospective, randomized study of Toremifene vs. tamoxifen for the treatment of premenopausal breast cancer: safety and genital symptom analysis. BMC Cancer. 2020 Jul 16;20(1):663. doi: 10.1186/s12885-020-07156-x.
PubMed 32677982
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Toremifene and Tamoxifen Therapy in Premenopausal Patients With Operable Breast Cancer: A Randomized, Controlled, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT02344940
- Acronym / sponsor ID
- TTOS / RJBC1401
- Conditions
- Breast Cancer
- Keywords
- operable, premenopausal, endocrine therapy, safety, tamoxifen, toremifene
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 26 Jan 2015 (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.
To compare the safety of toremifene and tamoxifen therapy in premenopausal patients with operable breast cancer by monitoring gynecological abnormality,blood lipid level,hepatic abnormality,estrogen level and perimenopausal symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| toremifene | Experimental | Drug: Toremifenepatients who will be treated with toremifene. |
| tamoxifen | Active comparator | Drug: Tamoxifenpatients who will be treated with tamoxifen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women aged ≥18 years, premenopausal
- Histologically confirmed invasive breast cancer by core needle biopsy, hormonal receptor positive, defined as estrogen receptor(ER)/progesterone receptor(PR) positive
- Patients must have received standard local therapy: normalized modified radical mastectomy or breast conserving surgery with negative margin and post-surgical radiotherapy. Patient should completed adjuvant therapy according to conditions, including adjuvant radiotherapy, neoadjuvant or adjuvant chemotherapy.
- Leukocyte ≥ 3*109/L; Platelets ≥ 75*109/L; Serum glutamate oxaloacetate(AST/SGOT) or serum glutamic-pyruvic transaminase(ALT/SGPT) <2.5 times of upper limit of normal (UNL) range Serum creatinine/blood urea nitrogen(BUN) ≤ upper limit of normal (UNL) range; Written informed consent according to the local ethics committee requirements.
- Has Eastern Cooperative Oncology Group(ECOG) Performance Score 0-2;
Key exclusion criteria (12 listed)
- Histologically confirmed hormonal receptor negative.
- Have received neoadjuvant/adjuvant endocrine therapy.
- With metastatic tumor.
- Family history of endometrial cancer or ovarian cancer or any other kind of gynecological malignant tumor.
- Have already been detected of ovarian abnormality or endometrial thickening by transvaginal ultrasound.
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 |
|---|---|---|
| ToremifeneAlso: Farestonpatients will take toremifene 60 mg qd. | Drug | toremifene |
| Tamoxifenpatients will take tamoxifen 10 mg bid. | Drug | tamoxifen |
Primary outcome
incidence of ovarian cyst
Time frame: participants will be followed during the first year of endocrine therapy
Ovarian cyst is defined as a purely liquid-filled structure that was equal to or exceeded 2 cm in its largest diameter detected by transvaginal ultrasonography.Participants will be required to receive transvaginal ultrasonography every 3 months.
6 secondary outcomes
incidence of endometrial thickening
Time frame: participants will be followed during the first year of endocrine therapy
change of female hormones
Time frame: participants will be followed during the first year of endocrine therapy
change of blood lipid
Time frame: participants will be followed during the first year of endocrine therapy
change of liver function
Time frame: participants will be followed during the first year of endocrine therapy
incidence of fatty liver
Time frame: participants will be followed during the first year of endocrine therapy
change of Kupperman index
Time frame: participants will be followed during the first year of endocrine therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Derived from this study: PubMed 32677982Hong J, Huang J, Shen L, Zhu S, Gao W, Wu J, Huang O, He J, Zhu L, Chen W, Li Y, Chen X, Shen K. A prospective, randomized study of Toremifene vs. tamoxifen for the treatment of premenopausal breast cancer: safety and genital symptom analysis. BMC Cancer. 2020 Jul 16;20(1):663. doi: 10.1186/s12885-020-07156-x.
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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.
Kunwei Shen, Professor principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Toremifene and Tamoxifen in people with Breast Cancer, run by Shanghai Jiao Tong University School of Medicine 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 5 inclusion and 12 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 24 Sep 2019. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
incidence of ovarian cyst (time frame: participants will be followed during the first year of endocrine therapy). 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 NCT02344940, 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 24 Sep 2019.