Safety of Toremifene and Tamoxifen Therapy in Premenopausal Patients With Operable Breast Cancer (TTOS)

September 23, 2019 updated by: Kunwei Shen, Shanghai Jiao Tong University School of Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women aged ≥18 years, premenopausal
  2. Histologically confirmed invasive breast cancer by core needle biopsy, hormonal receptor positive, defined as estrogen receptor(ER)/progesterone receptor(PR) positive
  3. 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.
  4. 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.
  5. Has Eastern Cooperative Oncology Group(ECOG) Performance Score 0-2;

Exclusion Criteria:

  1. Histologically confirmed hormonal receptor negative.
  2. Have received neoadjuvant/adjuvant endocrine therapy.
  3. With metastatic tumor.
  4. Family history of endometrial cancer or ovarian cancer or any other kind of gynecological malignant tumor.
  5. Have already been detected of ovarian abnormality or endometrial thickening by transvaginal ultrasound.
  6. With any of complications that will increase sex hormone level: pituitary adenoma，ovarian tumor, thymic cancer，etc.
  7. 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.
  8. Ovarian ablation or suppression
  9. With severe non-malignant co-morbidity that will influence long-term follow up.
  10. With severe hepatic dysfunction, Child-Pugh C.
  11. With severe cardiac dysfunction, New York Heart Association (NYHA) grading III or worse.
  12. Known severe hypersensitivity to any drugs in this study;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: toremifene
patients who will be treated with toremifene.
Drug: Toremifene
patients will take toremifene 60 mg qd.
Other Names:
  • Fareston
Active Comparator: tamoxifen
patients who will be treated with tamoxifen.
Drug: Tamoxifen
patients will take tamoxifen 10 mg bid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
participants will be followed during the first year of endocrine therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of endometrial thickening
Time Frame: participants will be followed during the first year of endocrine therapy
Endometrial thickness as measured with transvaginal ultrasonography is equal to or exceeded 8mm.Participants will be required to receive transvaginal ultrasonography every 3 months.
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 follicle stimulating hormone(FSH),luteinizing hormone(LH),estradiol(E2) as measured every 3 months
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 blood lipid as measured every 3 months
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
change of blood lipid as measured every 3 months
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
Incidence of fatty liver as examined by liver ultrasound every 3 months.
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
change of Kupperman index as measured every 3 months.
participants will be followed during the first year of endocrine therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Kunwei Shen, Professor, Ruijin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

January 5, 2015

First Submitted That Met QC Criteria

January 18, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Actual)

September 24, 2019

Last Update Submitted That Met QC Criteria

September 23, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJBC1401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Toremifene

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe