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

NCT02344940 | Completed Phase 4 DMC

• 1 other identifier: RJBC1401
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

operable; premenopausal; endocrine therapy; safety; tamoxifen; toremifene

Outcome Measures

Primary Outcomes (1)

• 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.

  participants will be followed during the first year of endocrine therapy

Secondary Outcomes (6)

• incidence of endometrial thickening

  participants will be followed during the first year of endocrine therapy

• change of female hormones

  participants will be followed during the first year of endocrine therapy

• change of blood lipid

  participants will be followed during the first year of endocrine therapy

• change of liver function

  participants will be followed during the first year of endocrine therapy

• incidence of fatty liver

  participants will be followed during the first year of endocrine therapy

Study Arms (2)

toremifene

EXPERIMENTAL

patients who will be treated with toremifene.

Drug: Toremifene

tamoxifen

ACTIVE COMPARATOR

patients who will be treated with tamoxifen.

Drug: Tamoxifen

Interventions

Toremifene DRUG

patients will take toremifene 60 mg qd.

Also known as: Fareston

toremifene

Tamoxifen DRUG

patients will take tamoxifen 10 mg bid.

tamoxifen

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (1)

• 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.

  PMID: 32677982 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Toremifene; Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Kunwei Shen, Professor

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: January 26, 2015
• Study Start: December 1, 2014
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 24, 2019

Record last verified: 2019-09

Locations

CN (1)