Prognostic Evaluation of Changing Endocrine Therapy in Women With Breast Cancer

NCT02097459 | Unknown Phase 3 DMC

• 1 other identifier: PUMCH-BREAST-AI
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast cancer; Endocrine therapy; Perimenopausal and recently postmenopausal patients; Early-stage hormone receptor-positive

Outcome Measures

Primary Outcomes (2)

• Disease free survival

  10 years

• Overall Survival

  10 years

Secondary Outcomes (2)

• Disease Free Survival

  5 years

• Overall Survival

  5 years

Other Outcomes (2)

• Disease Free Survival

  3 years

• Overall Survival

  3 years

Study Arms (3)

Failed group

EXPERIMENTAL

Patients who have recurrence of menstruation after changing endocrine therapy to anastrozole and then go back to the original SERMs therapy.

Drug: Anastrozole; Drug: Tamoxifen; Drug: Toremifene

Succeeded group

EXPERIMENTAL

Patients who have no recurrence of menstruation after changing endocrine therapy and then go on with anastrozole therapy.

Drug: Anastrozole

No chang group

ACTIVE COMPARATOR

Patients who don't change the endocrine therapy and go on with the original tamoxifen or toremifene therapy.

Drug: Tamoxifen; Drug: Toremifene

Interventions

Anastrozole DRUG

Also known as: Arimidex

Failed group; Succeeded group

Tamoxifen DRUG

Failed group; No chang group

Toremifene DRUG

Also known as: Fareston, Shu Rui

Failed group; No chang group

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anastrozole; Tamoxifen; Toremifene

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Qiang Sun, Doctor

  Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Qiang Sun, Doctor

CONTACT

8610-69152700; birds90@163.com

Yan Lin, Doctor

CONTACT

8610-69152700; birds90@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Breast Surgery Department, Professor

Study Record Dates

• First Submitted: March 19, 2014
• First Posted: March 27, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2024
• Last Updated: May 25, 2016

Record last verified: 2016-05

Locations

CN (1)