Prognostic Evaluation of Changing Endocrine Therapy in Women With Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02097459
Recruitment Status : Recruiting
First Posted : March 27, 2014
Last Update Posted : May 25, 2016
Information provided by (Responsible Party):
Qiang SUN, gwcmc

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Anastrozole Drug: Tamoxifen Drug: Toremifene Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prognostic Evaluation of Changing Endocrine Therapy in Perimenopausal and Recently Postmenopausal Women With Early-stage Hormone Receptor-Positive Breast Cancer
Study Start Date : March 2014
Estimated Primary Completion Date : March 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Failed group
Patients who have recurrence of menstruation after changing endocrine therapy to anastrozole and then go back to the original SERMs therapy.
Drug: Anastrozole
Other Name: Arimidex

Drug: Tamoxifen
Drug: Toremifene
Other Names:
  • Fareston
  • Shu Rui

Experimental: Succeeded group
Patients who have no recurrence of menstruation after changing endocrine therapy and then go on with anastrozole therapy.
Drug: Anastrozole
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.
Drug: Tamoxifen
Drug: Toremifene
Other Names:
  • Fareston
  • Shu Rui

Primary Outcome Measures :
  1. Disease free survival [ Time Frame: 10 years ]
  2. Overall Survival [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Disease Free Survival [ Time Frame: 5 years ]
  2. Overall Survival [ Time Frame: 5 years ]

Other Outcome Measures:
  1. Disease Free Survival [ Time Frame: 3 years ]
  2. Overall Survival [ Time Frame: 3 years ]

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Ages Eligible for Study:   45 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 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.

Exclusion Criteria:

  • 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.
  • Males.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02097459

Contact: Qiang Sun, Doctor 8610-69152700
Contact: Yan Lin, Doctor 8610-69152700

Peking Union Medical College Hospital Recruiting
Beijing, China, 100730
Contact: Qiang Sun, Doctor    8610-69152700   
Sponsors and Collaborators
Study Chair: Qiang Sun, Doctor gwcmc

Responsible Party: Qiang SUN, Chief of Breast Surgery Department, Professor, gwcmc Identifier: NCT02097459     History of Changes
Other Study ID Numbers: PUMCH-BREAST-AI
First Posted: March 27, 2014    Key Record Dates
Last Update Posted: May 25, 2016
Last Verified: May 2016

Keywords provided by Qiang SUN, gwcmc:
Breast cancer
Endocrine therapy
Perimenopausal and recently postmenopausal patients
Early-stage hormone receptor-positive

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action