- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02132390
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 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 Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Yidong ZHOU, Master
- Phone Number: 0086-10-69152700
- Email: wcj_sumy@126.com
Study Contact Backup
- Name: Changjun WANG, Doctor
- Phone Number: 0086-10-69152700
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Peking Union Medical College Hospital
-
Contact:
- Yidong ZHOU, Master
- Phone Number: 8610-69152700
- Email: wcj_sumy@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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
|
|
Experimental: Arm II
Patients who had CIA receive toremifene as in arm I
|
|
Experimental: Arm III
Patients without CIA receive oral toremifene and goserelin for ovarian function suppression
|
Other Names:
|
Experimental: Arm IV
Patients with CIA receive oral toremifene and goserelin for ovarian function suppression.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Survival
Time Frame: up to 120 months
|
up to 120 months
|
Disease free survival
Time Frame: up to 120 months
|
up to 120 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life
Time Frame: up to 120 months
|
up to 120 months
|
|
Bone mineral density loss
Time Frame: up to 120 months
|
measured by dual energy X-ray absorptiometry scans at every 12 months and by serum biomarkers
|
up to 120 months
|
Hormone levels
Time Frame: up to 120 months
|
up to 120 months
|
|
Incidence of pregnancy
Time Frame: up to 120 months
|
up to 120 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Menstruation Disturbances
- Breast Neoplasms
- Amenorrhea
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Bone Density Conservation Agents
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Goserelin
- Toremifene
Other Study ID Numbers
- PUMCH-Breast-CIA
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.
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