Prognostic Evaluation of Changing Endocrine Therapy in Women With Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Qiang SUN, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT02097459
First received: March 19, 2014
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Anastrozole
Drug: Tamoxifen
Drug: Toremifene
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

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: 600
Study Start Date: March 2014
Estimated Primary Completion Date: March 2024 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   45 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02097459

Locations
China
Peking Union Medical College Hospital
Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Study Chair: Qiang Sun, Doctor Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: Qiang SUN, Chief of Breast Surgery Department, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02097459     History of Changes
Other Study ID Numbers: PUMCH-BREAST-AI
Study First Received: March 19, 2014
Last Updated: March 24, 2014
Health Authority: China: Ministry of Health

Keywords provided by Peking Union Medical College Hospital:
Breast cancer
Endocrine therapy
Perimenopausal and recently postmenopausal patients
Early-stage hormone receptor-positive

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

ClinicalTrials.gov processed this record on August 28, 2014