Overview

Prognostic Evaluation of Changing Endocrine Therapy in Women With Breast Cancer

Status:
Recruiting
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Peking Union Medical College Hospital
Treatments:
Anastrozole
Tamoxifen
Toremifene
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.