Prognostic Evaluation of Changing Endocrine Therapy in Women With Breast Cancer

May 24, 2016 updated by: Qiang SUN, Peking Union Medical College Hospital

Prognostic Evaluation of Changing Endocrine Therapy in Perimenopausal and Recently Postmenopausal Women With Early-stage Hormone Receptor-Positive Breast Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Qiang Sun, Doctor
  • Phone Number: 8610-69152700
  • Email: birds90@163.com

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: Tamoxifen
Drug: Anastrozole
Other Names:
  • Arimidex
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease free survival
Time Frame: 10 years
10 years
Overall Survival
Time Frame: 10 years
10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 5 years
5 years
Disease Free Survival
Time Frame: 5 years
5 years

Other Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 3 years
3 years
Disease Free Survival
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Chair: Qiang Sun, Doctor, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

March 19, 2014

First Submitted That Met QC Criteria

March 24, 2014

First Posted (Estimate)

March 27, 2014

Study Record Updates

Last Update Posted (Estimate)

May 25, 2016

Last Update Submitted That Met QC Criteria

May 24, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-BREAST-AI

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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