Adjuvant Toremifene With or Without Goserrelin in Premenopausal Women With Stage I-IIIA, Hormonal Receptor Positive Breast Cancer Accompanied With or Without Chemotherapy Induced Amenorrhoea

Phase 3

• Conditions: Breast Cancer; Chemotherapy Induced Amenorrhea; Ovarian Function Suppression
• Interventions: Drug: Toremifene; Drug: Goserelin

• Registration Number: NCT02132390
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

Compare the potential benefits of adjuvant toremifene with or without goserelin in premenopausal women with stage I-IIIA, hormonal receptor positive breast cancer accompanied with or without chemotherapy induced amenorrhoea.

Detailed Description

This is a single center, randomized, controlled study. Patients undergo surgical resection with standard Doxorubicin/Cyclophosphamide Followed by Docetaxel (AC-T).

Chemotherapy begins within 4 weeks after surgery for patients randomized to arm I-IV. Arm I: patients who didn't have CIA receive oral toremifene daily. Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity. Arm II: patients who had CIA receive toremifene as in arm I. Arm III: patients without CIA receive oral toremifene and goserelin for ovarian function suppression. Arm IV: patients with CIA receive oral toremifene and goserelin for ovarian function suppression. Patients are followed every 6 months for 5 years and annually thereafter.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-05
• Study First Submitted QC: 2014-05-05
• Study First Posted: 2014-05-07
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-02
• Last Update Posted: 2014-06-04
• Primary Completion: 2024-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures
• Age of at least 18 and at most 45 years
• Spontaneous and regular menstrual periods before study entry with FSH below 15 mlU/ml in follicular phase
• Histologically confirmed primary breast cancer with the need for anthracycline-based chemotherapy
• 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
• Karnofsky-Index >80%
• 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 underwent standard Doxorubicin/Cyclophosphamide Followed by Docetaxel (AC-T)
• 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.

Exclusion Criteria

• Known hypersensitivity reaction to the investigational compounds or incorporated substances
• Prior cytotoxic treatment for any reason
• Suspected (primary or secondary) ovarian insufficiency
• Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration and must implement adequate non-hormonal contraceptive measures during study treatment; prior use of hormonal contraceptives has to be discontinued before first Goserelin injection
• Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study
• Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix)
• Concurrent treatment with other experimental drugs or any other anti-cancer therapy
• Concurrent treatment with sex hormones. Prior treatment must be stopped before study entry

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	Toremifene	Patients who didn't have CIA receive oral toremifene daily. Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity
Arm IV	Goserelin	Patients with CIA receive oral toremifene and goserelin for ovarian function suppression.
Arm II	Toremifene	Patients who had CIA receive toremifene as in arm I
Arm III	Goserelin	Patients without CIA receive oral toremifene and goserelin for ovarian function suppression

Primary Outcome Measures

Name	Time	Method
Disease free survival	up to 120 months
Overall Survival	up to 120 months

Secondary Outcome Measures

Name	Time	Method
Quality of life	up to 120 months
Bone mineral density loss	up to 120 months	measured by dual energy X-ray absorptiometry scans at every 12 months and by serum biomarkers
Hormone levels	up to 120 months
Incidence of pregnancy	up to 120 months

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China