Prognostic Evaluation of Changing Endocrine Therapy in Women With Breast Cancer
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Qiang SUN, Peking Union Medical College Hospital
First received: March 19, 2014
Last updated: March 24, 2014
Last verified: March 2014
It suggests in the Guideline that the postmenopausal women with breast cancer who have taken selective estrogen receptor modulators (SERMs) therapy for 2-3 years could benefit from changing endocrine therapy to aromatase inhibitors (AIs). This is a prospective, randomized and non-inferior trial to evaluate the prognosis of changing endocrine therapy from SERMs to AIs in perimenopausal and recently postmenopausal women with early-stage hormone receptor-positive breast cancer.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Prognostic Evaluation of Changing Endocrine Therapy in Perimenopausal and Recently Postmenopausal Women With Early-stage Hormone Receptor-Positive Breast Cancer
Primary Outcome Measures:
- Disease free survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Disease Free Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Other Outcome Measures:
- Disease Free Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||March 2024 (Final data collection date for primary outcome measure)
Experimental: Failed group
Patients who have recurrence of menstruation after changing endocrine therapy to anastrozole and then go back to the original SERMs therapy.
Other Name: Arimidex
Experimental: Succeeded group
Patients who have no recurrence of menstruation after changing endocrine therapy and then go on with anastrozole therapy.
Other Name: Arimidex
Active Comparator: No chang group
Patients who don't change the endocrine therapy and go on with the original tamoxifen or toremifene therapy.
|Ages Eligible for Study:
||45 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures.
- Age of at least 45 and at most 55 years.
- Performance status (Karnofsky-Index) ＞80%
- 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.
- Patients have taken the SERMs as endocrine therapy for 2-4 years.
- Patients who have had amenorrhea for at least half a year.
- 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 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.
- Known hypersensitivity reaction to the investigational compounds or incorporated substances.
- Hormone receptor-negative breast cancer.
- Local recurrence and/or metastasis of breast cancer.
- History of hysterectomy.
- Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration.
- History of osteoporosis and/or fractures due to osteoporosis.
- Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix)
- Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled high risk arrhythmias
- Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study.
- Concurrent treatment with other experimental drugs or any other anti-cancer therapy.
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02097459
|Peking Union Medical College Hospital
|Beijing, China, 100730 |
Peking Union Medical College Hospital
||Qiang Sun, Doctor
||Peking Union Medical College Hospital
No publications provided
||Qiang SUN, Chief of Breast Surgery Department, Professor, Peking Union Medical College Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 19, 2014
||March 24, 2014
||China: Ministry of Health
Keywords provided by Peking Union Medical College Hospital:
Perimenopausal and recently postmenopausal patients
Early-stage hormone receptor-positive
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 26, 2014
Neoplasms by Site
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Molecular Mechanisms of Pharmacological Action