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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

March 19, 2014
March 24, 2014
March 2014
March 2024   (final data collection date for primary outcome measure)
  • Disease free survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02097459 on ClinicalTrials.gov Archive Site
  • Disease Free Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
  • Disease Free Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
 
Prognostic Evaluation of Changing Endocrine Therapy in Women With Breast Cancer
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Anastrozole
    Other Name: Arimidex
  • Drug: Tamoxifen
  • Drug: Toremifene
    Other Names:
    • Fareston
    • Shu Rui
  • Experimental: Failed group
    Patients who have recurrence of menstruation after changing endocrine therapy to anastrozole and then go back to the original SERMs therapy.
    Interventions:
    • Drug: Anastrozole
    • Drug: Tamoxifen
    • Drug: Toremifene
  • Experimental: Succeeded group
    Patients who have no recurrence of menstruation after changing endocrine therapy and then go on with anastrozole therapy.
    Intervention: Drug: Anastrozole
  • Active Comparator: No chang group
    Patients who don't change the endocrine therapy and go on with the original tamoxifen or toremifene therapy.
    Interventions:
    • Drug: Tamoxifen
    • Drug: Toremifene
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
Not Provided
March 2024   (final data collection date for primary outcome measure)

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.
Female
45 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT02097459
PUMCH-BREAST-AI
Yes
Qiang SUN, Peking Union Medical College Hospital
Peking Union Medical College Hospital
Not Provided
Study Chair: Qiang Sun, Doctor Peking Union Medical College Hospital
Peking Union Medical College Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP