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

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT02132390

Collaborator

(none)

300

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Chemotherapy Induced Amenorrhea Ovarian Function Suppression	Drug: Goserelin Drug: Toremifene	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Study of 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

Study Start Date :

May 1, 2014

Anticipated Primary Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Toremifene
Experimental: Arm II Patients who had CIA receive toremifene as in arm I	Drug: Toremifene
Experimental: Arm III Patients without CIA receive oral toremifene and goserelin for ovarian function suppression	Drug: Goserelin Other Names: Zoladex
Experimental: Arm IV Patients with CIA receive oral toremifene and goserelin for ovarian function suppression.	Drug: Goserelin Other Names: Zoladex

Outcome Measures

Primary Outcome Measures

Disease free survival [up to 120 months]
Overall Survival [up to 120 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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